Trial Outcomes & Findings for Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study (NCT NCT05131477)
NCT ID: NCT05131477
Last Updated: 2025-07-03
Results Overview
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
390 participants
Primary outcome timeframe
Baseline to week 16
Results posted on
2025-07-03
Participant Flow
This study started in December 2021 and ended in February 2024. An individual participant was part of this study for about 1 year and 5 months. The study took place at 100 sites in 12 countries. Up to 350 participants (approximately 70 participants per treatment group) were planned to be enrolled.
The study was performed in 2 parts: Part 1 for all population (baseline to Week 24) for efficacy and safety and Part 2 for Part 1 Responders (Week 24 to Week 52 for efficacy and Week 24 to Week 68 for safety). Responders are defined as participants who achieved ≥EASI 75 and/or IGA 0/1 at Week 24.
Participant milestones
| Measure |
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
|
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
|
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PART 1
STARTED
|
77
|
78
|
77
|
79
|
79
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PART 1
Randomized and Treated
|
77
|
78
|
77
|
78
|
78
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PART 1
Re-randomized at Week 24
|
47
|
40
|
45
|
42
|
16
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PART 1
COMPLETED
|
68
|
62
|
69
|
67
|
57
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PART 1
NOT COMPLETED
|
9
|
16
|
8
|
12
|
22
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PART 2
STARTED
|
0
|
0
|
0
|
0
|
0
|
13
|
34
|
12
|
28
|
12
|
33
|
7
|
35
|
16
|
|
PART 2
Re-randomized and Treated
|
0
|
0
|
0
|
0
|
0
|
13
|
34
|
11
|
28
|
12
|
32
|
7
|
34
|
15
|
|
PART 2
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
12
|
31
|
11
|
24
|
11
|
28
|
7
|
29
|
13
|
|
PART 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
3
|
1
|
4
|
1
|
5
|
0
|
6
|
3
|
Reasons for withdrawal
| Measure |
250 mg (500 mg LD) KY1005 (Part 1)
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
|
250 mg (no LD) KY1005 (Part 1)
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
|
125 mg KY1005 (Part 1)
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PART 1
Withdrawal by Subject
|
2
|
9
|
6
|
2
|
8
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PART 1
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PART 1
Adverse Event
|
3
|
5
|
1
|
6
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PART 1
unclassified
|
1
|
1
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PART 1
Randomized and not treated
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PART 1
Protocol Violation
|
2
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PART 1
Lack of Efficacy
|
0
|
1
|
1
|
2
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
PART 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
2
|
0
|
2
|
2
|
|
PART 2
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
0
|
|
PART 2
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
3
|
0
|
1
|
0
|
2
|
0
|
|
PART 2
Unclassified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
PART 2
Re-randomized and not treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
1
|
Baseline Characteristics
There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
Baseline characteristics by cohort
| Measure |
250 mg (500 mg LD) KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
|
250 mg (No LD) KY1005 (Part 1)
n=78 Participants
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
|
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
Total
n=390 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.3 years
STANDARD_DEVIATION 13.32 • n=99 Participants
|
40.8 years
STANDARD_DEVIATION 15.24 • n=107 Participants
|
37.9 years
STANDARD_DEVIATION 15.17 • n=206 Participants
|
37.6 years
STANDARD_DEVIATION 14.78 • n=7 Participants
|
36.4 years
STANDARD_DEVIATION 13.07 • n=31 Participants
|
37.8 years
STANDARD_DEVIATION 14.36 • n=30 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
30 Participants
n=31 Participants
|
171 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
49 Participants
n=31 Participants
|
219 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=107 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=206 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=7 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=31 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=30 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=99 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
12 Participants
n=107 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
10 Participants
n=206 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
14 Participants
n=7 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
12 Participants
n=31 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
60 Participants
n=30 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=107 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=206 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=7 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=31 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=30 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
2 Participants
n=107 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
4 Participants
n=206 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
4 Participants
n=7 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
6 Participants
n=31 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
20 Participants
n=30 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
|
Race (NIH/OMB)
White
|
61 Participants
n=99 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
63 Participants
n=107 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
63 Participants
n=206 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
60 Participants
n=7 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
60 Participants
n=31 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
307 Participants
n=30 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=107 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=206 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=7 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=31 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=30 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
1 Participants
n=107 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
0 Participants
n=206 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
1 Participants
n=7 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
1 Participants
n=31 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
3 Participants
n=30 Participants • There were 390 participants enrolled in Part 1 and 190 participants enrolled in Part 2.
|
|
EASI Score at Baseline
|
30.3 units on a scale
STANDARD_DEVIATION 11.66 • n=99 Participants
|
28.7 units on a scale
STANDARD_DEVIATION 10.53 • n=107 Participants
|
30.3 units on a scale
STANDARD_DEVIATION 12.43 • n=206 Participants
|
28.7 units on a scale
STANDARD_DEVIATION 10.09 • n=7 Participants
|
26.4 units on a scale
STANDARD_DEVIATION 7.85 • n=31 Participants
|
28.9 units on a scale
STANDARD_DEVIATION 10.65 • n=30 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 16Population: Full Analysis Set for Part 1. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Efficacy analyses were based on treatment allocated at randomization. The Primary efficacy endpoint is the percentage of change in EASI from Baseline to Day 113 (Week 16). The primary analysis was conducted on FAS1 after all the randomized patients had reached the Day 169 (Week 24) visit/ early termination. Missing data were imputed by multiple imputation.
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)
|
-51.6 percentage of change
Standard Error 4.59
|
-59.6 percentage of change
Standard Error 4.53
|
-29.4 percentage of change
Standard Error 4.76
|
-61.5 percentage of change
Standard Error 4.68
|
-56.8 percentage of change
Standard Error 4.59
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage change from baseline in EASI at Day 169 (Week 24). Missing data were imputed by multiple imputation.
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1)
|
-53.7 percentage of change
Standard Error 5.08
|
-54.4 percentage of change
Standard Error 5.09
|
-27.6 percentage of change
Standard Error 5.29
|
-64.4 percentage of change
Standard Error 5.17
|
-52.2 percentage of change
Standard Error 5.14
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 16 and week 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage of patients with at least 75% reduction from baseline in EASI (EASI 5) at days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders.
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1)
Week 16
|
42.9 Percentage of participants
|
40.5 Percentage of participants
|
11.4 Percentage of participants
|
40.3 Percentage of participants
|
38.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1)
Week 24
|
49.4 Percentage of participants
|
40.5 Percentage of participants
|
17.7 Percentage of participants
|
54.5 Percentage of participants
|
38.5 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 16 and week 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Percentage of patients with a response of IGA 0 or 1 and a reduction from baseline of ≥ 2 points at Days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders.
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear,1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1)
Week 16
|
19.5 Percentage of participants
|
25.3 Percentage of participants
|
5.1 Percentage of participants
|
22.1 Percentage of participants
|
14.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1)
Week 24
|
40.3 Percentage of participants
|
29.1 Percentage of participants
|
11.4 Percentage of participants
|
45.5 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 16 and week 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. The primary analysis was conducted on the FAS1 after all randomized patients had reached day 169 (Week 24) visit/ early termination. Proportion of patients with improvement (reduction) of weekly average of pruritus NRS ≥ 4 a baseline pruritus NRS of ≥ 4 from baseline to Days 113 (Week 16) and Day 169 (Week 24). Participants with missing data were considered as non-responders.
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1)
Week 16
|
20.8 Percentage of participants
|
22.8 Percentage of participants
|
5.1 Percentage of participants
|
24.7 Percentage of participants
|
19.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1)
Week 24
|
28.6 Percentage of participants
|
27.8 Percentage of participants
|
7.6 Percentage of participants
|
31.2 Percentage of participants
|
24.4 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks week 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported. Participants with missing data were considered as non-responders.
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 25
|
66.7 Percentage of participants
|
39.3 Percentage of participants
|
66.7 Percentage of participants
|
53.8 Percentage of participants
|
41.2 Percentage of participants
|
39.4 Percentage of participants
|
57.1 Percentage of participants
|
37.1 Percentage of participants
|
31.3 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 26
|
66.7 Percentage of participants
|
32.1 Percentage of participants
|
58.3 Percentage of participants
|
53.8 Percentage of participants
|
38.2 Percentage of participants
|
33.3 Percentage of participants
|
71.4 Percentage of participants
|
42.9 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 40
|
33.3 Percentage of participants
|
25.0 Percentage of participants
|
58.3 Percentage of participants
|
53.8 Percentage of participants
|
38.2 Percentage of participants
|
36.4 Percentage of participants
|
28.6 Percentage of participants
|
31.4 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 42
|
50.0 Percentage of participants
|
28.6 Percentage of participants
|
66.7 Percentage of participants
|
53.8 Percentage of participants
|
38.2 Percentage of participants
|
36.4 Percentage of participants
|
42.9 Percentage of participants
|
31.4 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 52
|
41.7 Percentage of participants
|
25.0 Percentage of participants
|
66.7 Percentage of participants
|
46.2 Percentage of participants
|
29.4 Percentage of participants
|
27.3 Percentage of participants
|
57.1 Percentage of participants
|
40.0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 24
|
75.0 Percentage of participants
|
35.7 Percentage of participants
|
58.3 Percentage of participants
|
53.8 Percentage of participants
|
41.2 Percentage of participants
|
45.5 Percentage of participants
|
71.4 Percentage of participants
|
45.7 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 27
|
58.3 Percentage of participants
|
28.6 Percentage of participants
|
58.3 Percentage of participants
|
61.5 Percentage of participants
|
35.3 Percentage of participants
|
39.4 Percentage of participants
|
71.4 Percentage of participants
|
37.1 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 28
|
66.7 Percentage of participants
|
35.7 Percentage of participants
|
58.3 Percentage of participants
|
61.5 Percentage of participants
|
35.3 Percentage of participants
|
42.4 Percentage of participants
|
57.1 Percentage of participants
|
37.1 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 29
|
50.0 Percentage of participants
|
25.0 Percentage of participants
|
58.3 Percentage of participants
|
69.2 Percentage of participants
|
38.2 Percentage of participants
|
45.5 Percentage of participants
|
57.1 Percentage of participants
|
40.0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 30
|
58.3 Percentage of participants
|
25.0 Percentage of participants
|
66.7 Percentage of participants
|
61.5 Percentage of participants
|
44.1 Percentage of participants
|
36.4 Percentage of participants
|
42.9 Percentage of participants
|
42.9 Percentage of participants
|
18.8 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 31
|
58.3 Percentage of participants
|
25.0 Percentage of participants
|
66.7 Percentage of participants
|
61.5 Percentage of participants
|
41.2 Percentage of participants
|
36.4 Percentage of participants
|
42.9 Percentage of participants
|
40.0 Percentage of participants
|
18.8 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 32
|
50.0 Percentage of participants
|
25.0 Percentage of participants
|
75.0 Percentage of participants
|
61.5 Percentage of participants
|
47.1 Percentage of participants
|
42.4 Percentage of participants
|
71.4 Percentage of participants
|
40.0 Percentage of participants
|
18.8 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 33
|
58.3 Percentage of participants
|
28.6 Percentage of participants
|
58.3 Percentage of participants
|
61.5 Percentage of participants
|
47.1 Percentage of participants
|
42.4 Percentage of participants
|
71.4 Percentage of participants
|
40.0 Percentage of participants
|
18.8 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 34
|
75.0 Percentage of participants
|
21.4 Percentage of participants
|
75.0 Percentage of participants
|
61.5 Percentage of participants
|
41.2 Percentage of participants
|
30.3 Percentage of participants
|
42.9 Percentage of participants
|
37.1 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 35
|
66.7 Percentage of participants
|
21.4 Percentage of participants
|
66.7 Percentage of participants
|
61.5 Percentage of participants
|
41.2 Percentage of participants
|
39.4 Percentage of participants
|
71.4 Percentage of participants
|
34.3 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 36
|
58.3 Percentage of participants
|
21.4 Percentage of participants
|
66.7 Percentage of participants
|
61.5 Percentage of participants
|
38.2 Percentage of participants
|
42.4 Percentage of participants
|
71.4 Percentage of participants
|
40.0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 37
|
50.0 Percentage of participants
|
28.6 Percentage of participants
|
66.7 Percentage of participants
|
53.8 Percentage of participants
|
41.2 Percentage of participants
|
42.4 Percentage of participants
|
71.4 Percentage of participants
|
37.1 Percentage of participants
|
18.8 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 38
|
50.0 Percentage of participants
|
25.0 Percentage of participants
|
58.3 Percentage of participants
|
53.8 Percentage of participants
|
35.3 Percentage of participants
|
42.4 Percentage of participants
|
71.4 Percentage of participants
|
31.4 Percentage of participants
|
18.8 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 39
|
50.0 Percentage of participants
|
25.0 Percentage of participants
|
58.3 Percentage of participants
|
53.8 Percentage of participants
|
41.2 Percentage of participants
|
39.4 Percentage of participants
|
71.4 Percentage of participants
|
31.4 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 41
|
41.7 Percentage of participants
|
28.6 Percentage of participants
|
66.7 Percentage of participants
|
61.5 Percentage of participants
|
35.3 Percentage of participants
|
39.4 Percentage of participants
|
57.1 Percentage of participants
|
34.3 Percentage of participants
|
31.3 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 43
|
50.0 Percentage of participants
|
28.6 Percentage of participants
|
58.3 Percentage of participants
|
53.8 Percentage of participants
|
35.3 Percentage of participants
|
36.4 Percentage of participants
|
42.9 Percentage of participants
|
34.3 Percentage of participants
|
31.3 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 44
|
41.7 Percentage of participants
|
21.4 Percentage of participants
|
75.0 Percentage of participants
|
61.5 Percentage of participants
|
38.2 Percentage of participants
|
39.4 Percentage of participants
|
42.9 Percentage of participants
|
37.1 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 45
|
41.7 Percentage of participants
|
21.4 Percentage of participants
|
75.0 Percentage of participants
|
61.5 Percentage of participants
|
41.2 Percentage of participants
|
36.4 Percentage of participants
|
42.9 Percentage of participants
|
40.0 Percentage of participants
|
31.3 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 46
|
50.0 Percentage of participants
|
28.6 Percentage of participants
|
50.0 Percentage of participants
|
53.8 Percentage of participants
|
44.1 Percentage of participants
|
27.3 Percentage of participants
|
42.9 Percentage of participants
|
37.1 Percentage of participants
|
31.3 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 47
|
33.3 Percentage of participants
|
28.6 Percentage of participants
|
58.3 Percentage of participants
|
46.2 Percentage of participants
|
38.2 Percentage of participants
|
30.3 Percentage of participants
|
42.9 Percentage of participants
|
45.7 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 48
|
41.7 Percentage of participants
|
28.6 Percentage of participants
|
66.7 Percentage of participants
|
38.5 Percentage of participants
|
35.3 Percentage of participants
|
27.3 Percentage of participants
|
57.1 Percentage of participants
|
37.1 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 49
|
50.0 Percentage of participants
|
35.7 Percentage of participants
|
66.7 Percentage of participants
|
38.5 Percentage of participants
|
41.2 Percentage of participants
|
30.3 Percentage of participants
|
57.1 Percentage of participants
|
40.0 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 50
|
50.0 Percentage of participants
|
32.1 Percentage of participants
|
66.7 Percentage of participants
|
38.5 Percentage of participants
|
35.3 Percentage of participants
|
24.2 Percentage of participants
|
57.1 Percentage of participants
|
37.1 Percentage of participants
|
25.0 Percentage of participants
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)
Week 51
|
41.7 Percentage of participants
|
28.6 Percentage of participants
|
58.3 Percentage of participants
|
30.8 Percentage of participants
|
32.4 Percentage of participants
|
27.3 Percentage of participants
|
42.9 Percentage of participants
|
34.3 Percentage of participants
|
25.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Week 12
|
-16.56 score on a scale
Standard Deviation 14.062
|
-16.46 score on a scale
Standard Deviation 11.699
|
-8.76 score on a scale
Standard Deviation 9.608
|
-18.49 score on a scale
Standard Deviation 12.411
|
-13.84 score on a scale
Standard Deviation 11.121
|
—
|
—
|
—
|
—
|
|
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Week 20
|
-16.98 score on a scale
Standard Deviation 15.321
|
-16.76 score on a scale
Standard Deviation 12.590
|
-7.91 score on a scale
Standard Deviation 11.163
|
-21.93 score on a scale
Standard Deviation 14.283
|
-16.46 score on a scale
Standard Deviation 12.834
|
—
|
—
|
—
|
—
|
|
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Week 2
|
-6.17 score on a scale
Standard Deviation 10.071
|
-7.51 score on a scale
Standard Deviation 8.836
|
-3.98 score on a scale
Standard Deviation 7.855
|
-8.49 score on a scale
Standard Deviation 10.777
|
-5.27 score on a scale
Standard Deviation 8.485
|
—
|
—
|
—
|
—
|
|
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Week 4
|
-10.33 score on a scale
Standard Deviation 10.861
|
-10.27 score on a scale
Standard Deviation 10.550
|
-7.20 score on a scale
Standard Deviation 8.510
|
-11.21 score on a scale
Standard Deviation 10.612
|
-8.38 score on a scale
Standard Deviation 9.944
|
—
|
—
|
—
|
—
|
|
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Week 8
|
-13.77 score on a scale
Standard Deviation 12.964
|
-14.37 score on a scale
Standard Deviation 10.054
|
-7.64 score on a scale
Standard Deviation 10.450
|
-15.67 score on a scale
Standard Deviation 11.872
|
-11.93 score on a scale
Standard Deviation 11.018
|
—
|
—
|
—
|
—
|
|
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Week 16
|
-15.70 score on a scale
Standard Deviation 14.226
|
-17.82 score on a scale
Standard Deviation 11.730
|
-7.47 score on a scale
Standard Deviation 11.338
|
-19.71 score on a scale
Standard Deviation 12.731
|
-16.31 score on a scale
Standard Deviation 12.329
|
—
|
—
|
—
|
—
|
|
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Week 24
|
-16.91 score on a scale
Standard Deviation 15.085
|
-17.09 score on a scale
Standard Deviation 13.088
|
-7.52 score on a scale
Standard Deviation 12.537
|
-21.92 score on a scale
Standard Deviation 14.475
|
-15.72 score on a scale
Standard Deviation 12.977
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 2,4, 8,12,16, 20 and 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Week 2
|
-19.09 Percentage of change
Standard Deviation 39.499
|
-26.03 Percentage of change
Standard Deviation 34.462
|
-15.26 Percentage of change
Standard Deviation 34.143
|
-27.94 Percentage of change
Standard Deviation 30.032
|
-17.75 Percentage of change
Standard Deviation 38.988
|
—
|
—
|
—
|
—
|
|
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Week 4
|
-35.10 Percentage of change
Standard Deviation 34.457
|
-35.49 Percentage of change
Standard Deviation 38.786
|
-27.56 Percentage of change
Standard Deviation 31.037
|
-36.85 Percentage of change
Standard Deviation 28.901
|
-29.13 Percentage of change
Standard Deviation 42.013
|
—
|
—
|
—
|
—
|
|
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Week 8
|
-45.96 Percentage of change
Standard Deviation 38.150
|
-51.70 Percentage of change
Standard Deviation 31.046
|
-28.70 Percentage of change
Standard Deviation 38.603
|
-50.25 Percentage of change
Standard Deviation 30.666
|
-41.21 Percentage of change
Standard Deviation 41.129
|
—
|
—
|
—
|
—
|
|
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Week 12
|
-55.23 Percentage of change
Standard Deviation 40.218
|
-57.36 Percentage of change
Standard Deviation 34.275
|
-33.72 Percentage of change
Standard Deviation 35.358
|
-59.61 Percentage of change
Standard Deviation 30.717
|
-50.15 Percentage of change
Standard Deviation 36.086
|
—
|
—
|
—
|
—
|
|
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Week 16
|
-52.50 Percentage of change
Standard Deviation 40.820
|
-61.51 Percentage of change
Standard Deviation 31.663
|
-28.25 Percentage of change
Standard Deviation 41.173
|
-62.35 Percentage of change
Standard Deviation 32.322
|
-59.98 Percentage of change
Standard Deviation 37.444
|
—
|
—
|
—
|
—
|
|
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Week 20
|
-56.29 Percentage of change
Standard Deviation 43.103
|
-57.87 Percentage of change
Standard Deviation 38.977
|
-30.32 Percentage of change
Standard Deviation 40.486
|
-67.85 Percentage of change
Standard Deviation 33.135
|
-57.80 Percentage of change
Standard Deviation 38.921
|
—
|
—
|
—
|
—
|
|
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)
Week 24
|
-56.72 Percentage of change
Standard Deviation 44.271
|
-57.37 Percentage of change
Standard Deviation 40.225
|
-28.55 Percentage of change
Standard Deviation 44.004
|
-68.01 Percentage of change
Standard Deviation 36.052
|
-55.84 Percentage of change
Standard Deviation 40.299
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported.
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 28
|
-25.86 Score on a scale
Standard Deviation 13.128
|
-17.29 Score on a scale
Standard Deviation 12.458
|
-26.37 Score on a scale
Standard Deviation 13.067
|
-30.51 Score on a scale
Standard Deviation 12.422
|
-26.34 Score on a scale
Standard Deviation 14.353
|
-22.87 Score on a scale
Standard Deviation 15.667
|
-23.79 Score on a scale
Standard Deviation 10.424
|
-21.75 Score on a scale
Standard Deviation 13.106
|
-21.69 Score on a scale
Standard Deviation 11.918
|
|
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 24
|
-27.60 Score on a scale
Standard Deviation 11.170
|
-18.90 Score on a scale
Standard Deviation 11.932
|
-27.10 Score on a scale
Standard Deviation 12.670
|
-29.65 Score on a scale
Standard Deviation 11.278
|
-26.28 Score on a scale
Standard Deviation 13.353
|
-22.45 Score on a scale
Standard Deviation 14.998
|
-25.47 Score on a scale
Standard Deviation 12.209
|
-22.41 Score on a scale
Standard Deviation 12.841
|
-21.47 Score on a scale
Standard Deviation 10.420
|
|
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 32
|
-22.99 Score on a scale
Standard Deviation 15.741
|
-15.38 Score on a scale
Standard Deviation 12.620
|
-27.36 Score on a scale
Standard Deviation 13.383
|
-29.08 Score on a scale
Standard Deviation 14.544
|
-24.79 Score on a scale
Standard Deviation 15.775
|
-22.94 Score on a scale
Standard Deviation 14.915
|
-24.94 Score on a scale
Standard Deviation 11.245
|
-20.32 Score on a scale
Standard Deviation 14.189
|
-19.60 Score on a scale
Standard Deviation 10.632
|
|
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 40
|
-22.56 Score on a scale
Standard Deviation 14.949
|
-14.81 Score on a scale
Standard Deviation 13.178
|
-27.96 Score on a scale
Standard Deviation 14.444
|
-28.54 Score on a scale
Standard Deviation 15.203
|
-22.30 Score on a scale
Standard Deviation 17.908
|
-20.45 Score on a scale
Standard Deviation 16.659
|
-25.51 Score on a scale
Standard Deviation 11.796
|
-20.80 Score on a scale
Standard Deviation 14.601
|
-20.05 Score on a scale
Standard Deviation 10.596
|
|
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 36
|
-22.27 Score on a scale
Standard Deviation 16.368
|
-14.57 Score on a scale
Standard Deviation 13.550
|
-27.51 Score on a scale
Standard Deviation 13.550
|
-28.15 Score on a scale
Standard Deviation 15.138
|
-22.78 Score on a scale
Standard Deviation 17.505
|
-22.99 Score on a scale
Standard Deviation 14.978
|
-24.65 Score on a scale
Standard Deviation 10.801
|
-20.09 Score on a scale
Standard Deviation 15.098
|
-20.20 Score on a scale
Standard Deviation 10.436
|
|
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 44
|
-23.07 Score on a scale
Standard Deviation 15.679
|
-14.49 Score on a scale
Standard Deviation 12.877
|
-27.49 Score on a scale
Standard Deviation 14.324
|
-28.43 Score on a scale
Standard Deviation 15.061
|
-22.23 Score on a scale
Standard Deviation 17.487
|
-19.76 Score on a scale
Standard Deviation 16.561
|
-22.34 Score on a scale
Standard Deviation 11.070
|
-20.70 Score on a scale
Standard Deviation 14.343
|
-20.43 Score on a scale
Standard Deviation 11.007
|
|
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 48
|
-22.24 Score on a scale
Standard Deviation 16.312
|
-13.95 Score on a scale
Standard Deviation 13.596
|
-27.72 Score on a scale
Standard Deviation 14.882
|
-22.15 Score on a scale
Standard Deviation 14.876
|
-21.82 Score on a scale
Standard Deviation 17.764
|
-18.34 Score on a scale
Standard Deviation 16.959
|
-23.88 Score on a scale
Standard Deviation 12.517
|
-19.74 Score on a scale
Standard Deviation 15.277
|
-19.99 Score on a scale
Standard Deviation 11.292
|
|
Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 52
|
-22.68 Score on a scale
Standard Deviation 15.418
|
-13.89 Score on a scale
Standard Deviation 13.427
|
-28.08 Score on a scale
Standard Deviation 16.097
|
-22.03 Score on a scale
Standard Deviation 14.889
|
-19.59 Score on a scale
Standard Deviation 15.321
|
-17.30 Score on a scale
Standard Deviation 16.752
|
-23.26 Score on a scale
Standard Deviation 11.789
|
-20.81 Score on a scale
Standard Deviation 14.813
|
-20.30 Score on a scale
Standard Deviation 11.526
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported.
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 24
|
-84.20 Percentage of change
Standard Deviation 16.741
|
-72.72 Percentage of change
Standard Deviation 41.299
|
-90.91 Percentage of change
Standard Deviation 10.585
|
-91.71 Percentage of change
Standard Deviation 8.539
|
-81.85 Percentage of change
Standard Deviation 31.624
|
-74.56 Percentage of change
Standard Deviation 39.811
|
-85.81 Percentage of change
Standard Deviation 10.212
|
-76.74 Percentage of change
Standard Deviation 30.922
|
-78.51 Percentage of change
Standard Deviation 28.977
|
|
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 28
|
-79.34 Percentage of change
Standard Deviation 28.091
|
-66.53 Percentage of change
Standard Deviation 43.437
|
-87.78 Percentage of change
Standard Deviation 13.648
|
-93.56 Percentage of change
Standard Deviation 8.382
|
-81.47 Percentage of change
Standard Deviation 32.251
|
-74.18 Percentage of change
Standard Deviation 42.104
|
-89.88 Percentage of change
Standard Deviation 6.304
|
-74.54 Percentage of change
Standard Deviation 31.665
|
-76.87 Percentage of change
Standard Deviation 31.377
|
|
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 32
|
-69.06 Percentage of change
Standard Deviation 38.468
|
-58.78 Percentage of change
Standard Deviation 44.767
|
-91.07 Percentage of change
Standard Deviation 13.744
|
-86.08 Percentage of change
Standard Deviation 24.896
|
-76.51 Percentage of change
Standard Deviation 38.401
|
-75.64 Percentage of change
Standard Deviation 41.038
|
-93.76 Percentage of change
Standard Deviation 4.960
|
-68.09 Percentage of change
Standard Deviation 34.850
|
-71.98 Percentage of change
Standard Deviation 33.063
|
|
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 36
|
-66.64 Percentage of change
Standard Deviation 39.631
|
-56.24 Percentage of change
Standard Deviation 46.469
|
-91.22 Percentage of change
Standard Deviation 13.203
|
-86.56 Percentage of change
Standard Deviation 28.656
|
-69.33 Percentage of change
Standard Deviation 43.838
|
-75.77 Percentage of change
Standard Deviation 40.984
|
-93.09 Percentage of change
Standard Deviation 6.000
|
-67.27 Percentage of change
Standard Deviation 40.162
|
-74.93 Percentage of change
Standard Deviation 32.664
|
|
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 40
|
-68.31 Percentage of change
Standard Deviation 38.024
|
-57.39 Percentage of change
Standard Deviation 47.379
|
-90.68 Percentage of change
Standard Deviation 13.737
|
-84.74 Percentage of change
Standard Deviation 28.948
|
-65.65 Percentage of change
Standard Deviation 44.932
|
-64.68 Percentage of change
Standard Deviation 64.041
|
-95.55 Percentage of change
Standard Deviation 5.011
|
-70.11 Percentage of change
Standard Deviation 37.802
|
-74.05 Percentage of change
Standard Deviation 32.343
|
|
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 44
|
-69.41 Percentage of change
Standard Deviation 38.731
|
-56.30 Percentage of change
Standard Deviation 46.700
|
-90.18 Percentage of change
Standard Deviation 12.912
|
-84.46 Percentage of change
Standard Deviation 28.757
|
-66.73 Percentage of change
Standard Deviation 44.328
|
-62.46 Percentage of change
Standard Deviation 63.983
|
-83.57 Percentage of change
Standard Deviation 21.909
|
-69.98 Percentage of change
Standard Deviation 37.145
|
-72.99 Percentage of change
Standard Deviation 33.353
|
|
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 48
|
-66.61 Percentage of change
Standard Deviation 39.645
|
-53.59 Percentage of change
Standard Deviation 48.780
|
-90.26 Percentage of change
Standard Deviation 12.961
|
-71.66 Percentage of change
Standard Deviation 40.416
|
-65.18 Percentage of change
Standard Deviation 44.327
|
-57.47 Percentage of change
Standard Deviation 65.142
|
-88.02 Percentage of change
Standard Deviation 22.234
|
-66.63 Percentage of change
Standard Deviation 40.889
|
-70.92 Percentage of change
Standard Deviation 33.888
|
|
Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)
Week 52
|
-68.09 Percentage of change
Standard Deviation 37.719
|
-53.58 Percentage of change
Standard Deviation 48.725
|
-89.09 Percentage of change
Standard Deviation 15.625
|
-71.22 Percentage of change
Standard Deviation 40.152
|
-61.78 Percentage of change
Standard Deviation 44.406
|
-54.42 Percentage of change
Standard Deviation 65.177
|
-86.51 Percentage of change
Standard Deviation 22.331
|
-69.76 Percentage of change
Standard Deviation 38.241
|
-72.04 Percentage of change
Standard Deviation 34.827
|
SECONDARY outcome
Timeframe: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participant with missing data were considered as non-responders.
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)
Week 2
|
16.9 Percentage of participants
|
22.8 Percentage of participants
|
13.9 Percentage of participants
|
19.5 Percentage of participants
|
15.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)
Week 4
|
39.0 Percentage of participants
|
39.2 Percentage of participants
|
24.1 Percentage of participants
|
29.9 Percentage of participants
|
21.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)
Week 8
|
53.2 Percentage of participants
|
54.4 Percentage of participants
|
27.8 Percentage of participants
|
45.5 Percentage of participants
|
38.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)
Week 12
|
61.0 Percentage of participants
|
62.0 Percentage of participants
|
26.6 Percentage of participants
|
62.3 Percentage of participants
|
44.9 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)
Week 16
|
57.1 Percentage of participants
|
65.8 Percentage of participants
|
27.8 Percentage of participants
|
63.6 Percentage of participants
|
52.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)
Week 20
|
58.4 Percentage of participants
|
58.2 Percentage of participants
|
25.3 Percentage of participants
|
63.6 Percentage of participants
|
51.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)
Week 24
|
55.8 Percentage of participants
|
53.2 Percentage of participants
|
24.1 Percentage of participants
|
66.2 Percentage of participants
|
43.6 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline at weeks 2, 4, 8, 12, 16, 20 and 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)
Week 2
|
2.6 Percentage of participants
|
2.5 Percentage of participants
|
5.1 Percentage of participants
|
9.1 Percentage of participants
|
2.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)
Week 4
|
11.7 Percentage of participants
|
11.4 Percentage of participants
|
6.3 Percentage of participants
|
9.1 Percentage of participants
|
9.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)
Week 8
|
27.3 Percentage of participants
|
25.3 Percentage of participants
|
8.9 Percentage of participants
|
23.4 Percentage of participants
|
16.7 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)
Week 12
|
44.2 Percentage of participants
|
43.0 Percentage of participants
|
11.4 Percentage of participants
|
33.8 Percentage of participants
|
25.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)
Week 16
|
42.9 Percentage of participants
|
40.5 Percentage of participants
|
11.4 Percentage of participants
|
40.3 Percentage of participants
|
38.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)
Week 20
|
48.1 Percentage of participants
|
40.5 Percentage of participants
|
13.9 Percentage of participants
|
49.4 Percentage of participants
|
42.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)
Week 24
|
49.4 Percentage of participants
|
40.5 Percentage of participants
|
17.7 Percentage of participants
|
54.5 Percentage of participants
|
38.5 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)
Week 2
|
0 Percentage of participants
|
1.3 Percentage of participants
|
0 Percentage of participants
|
2.6 Percentage of participants
|
1.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)
Week 4
|
1.3 Percentage of participants
|
2.5 Percentage of participants
|
0 Percentage of participants
|
6.5 Percentage of participants
|
1.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)
Week 8
|
9.1 Percentage of participants
|
8.9 Percentage of participants
|
1.3 Percentage of participants
|
7.8 Percentage of participants
|
7.7 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)
Week 12
|
14.3 Percentage of participants
|
12.7 Percentage of participants
|
5.1 Percentage of participants
|
10.4 Percentage of participants
|
9.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)
Week 16
|
16.9 Percentage of participants
|
19.0 Percentage of participants
|
3.8 Percentage of participants
|
15.6 Percentage of participants
|
14.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)
Week 20
|
24.7 Percentage of participants
|
19.0 Percentage of participants
|
7.6 Percentage of participants
|
27.3 Percentage of participants
|
23.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)
Week 24
|
32.5 Percentage of participants
|
24.1 Percentage of participants
|
11.4 Percentage of participants
|
37.7 Percentage of participants
|
26.9 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 2, 4, 8, 12, 16, 20 and 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)
Week 2
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)
Week 4
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.6 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)
Week 8
|
1.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.6 Percentage of participants
|
5.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)
Week 12
|
2.6 Percentage of participants
|
2.5 Percentage of participants
|
0 Percentage of participants
|
3.9 Percentage of participants
|
2.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)
Week 16
|
2.6 Percentage of participants
|
1.3 Percentage of participants
|
1.3 Percentage of participants
|
3.9 Percentage of participants
|
1.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)
Week 20
|
3.9 Percentage of participants
|
2.5 Percentage of participants
|
1.3 Percentage of participants
|
6.5 Percentage of participants
|
6.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)
Week 24
|
9.1 Percentage of participants
|
1.3 Percentage of participants
|
3.8 Percentage of participants
|
7.8 Percentage of participants
|
6.4 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)
Week 2
|
-0.29 Score on a scale
Standard Deviation 0.540
|
-0.23 Score on a scale
Standard Deviation 0.481
|
-0.18 Score on a scale
Standard Deviation 0.503
|
-0.33 Score on a scale
Standard Deviation 0.625
|
-0.21 Score on a scale
Standard Deviation 0.408
|
—
|
—
|
—
|
—
|
|
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)
Week 4
|
-0.45 Score on a scale
Standard Deviation 0.620
|
-0.51 Score on a scale
Standard Deviation 0.661
|
-0.31 Score on a scale
Standard Deviation 0.592
|
-0.57 Score on a scale
Standard Deviation 0.869
|
-0.38 Score on a scale
Standard Deviation 0.590
|
—
|
—
|
—
|
—
|
|
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)
Week 8
|
-0.80 Score on a scale
Standard Deviation 0.900
|
-0.76 Score on a scale
Standard Deviation 0.709
|
-0.32 Score on a scale
Standard Deviation 0.728
|
-0.79 Score on a scale
Standard Deviation 0.976
|
-0.74 Score on a scale
Standard Deviation 0.829
|
—
|
—
|
—
|
—
|
|
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)
Week 12
|
-1.04 Score on a scale
Standard Deviation 1.013
|
-1.00 Score on a scale
Standard Deviation 0.973
|
-0.36 Score on a scale
Standard Deviation 0.660
|
-1.10 Score on a scale
Standard Deviation 1.024
|
-0.87 Score on a scale
Standard Deviation 0.867
|
—
|
—
|
—
|
—
|
|
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)
Week 16
|
-0.96 Score on a scale
Standard Deviation 1.033
|
-1.09 Score on a scale
Standard Deviation 0.969
|
-0.43 Score on a scale
Standard Deviation 0.757
|
-1.23 Score on a scale
Standard Deviation 0.981
|
-0.99 Score on a scale
Standard Deviation 0.899
|
—
|
—
|
—
|
—
|
|
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)
Week 20
|
-1.11 Score on a scale
Standard Deviation 1.120
|
-1.10 Score on a scale
Standard Deviation 0.981
|
-0.45 Score on a scale
Standard Deviation 0.822
|
-1.43 Score on a scale
Standard Deviation 1.118
|
-1.17 Score on a scale
Standard Deviation 1.137
|
—
|
—
|
—
|
—
|
|
Change in IGA (Investigator Global Assessment) From Baseline to (Week 24) (Part 1)
Week 24
|
-1.32 Score on a scale
Standard Deviation 1.265
|
-1.16 Score on a scale
Standard Deviation 1.030
|
-0.49 Score on a scale
Standard Deviation 0.959
|
-1.48 Score on a scale
Standard Deviation 1.205
|
-1.16 Score on a scale
Standard Deviation 1.241
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 28, 31, 36, 40, 44, 48 & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints are reported.
The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Change in IGA (Investigator Global Assessment) From Baseline (Part 2)
Week 52
|
-1.64 Score on a scale
Standard Deviation 1.286
|
-1.36 Score on a scale
Standard Deviation 1.420
|
-2.18 Score on a scale
Standard Deviation 1.401
|
-1.77 Score on a scale
Standard Deviation 1.301
|
-1.55 Score on a scale
Standard Deviation 1.434
|
-1.48 Score on a scale
Standard Deviation 1.214
|
-2.00 Score on a scale
Standard Deviation 1.155
|
-1.65 Score on a scale
Standard Deviation 1.305
|
-1.79 Score on a scale
Standard Deviation 1.672
|
|
Change in IGA (Investigator Global Assessment) From Baseline (Part 2)
Week 40
|
-1.64 Score on a scale
Standard Deviation 1.286
|
-1.29 Score on a scale
Standard Deviation 1.301
|
-2.36 Score on a scale
Standard Deviation 1.120
|
-2.08 Score on a scale
Standard Deviation 1.115
|
-1.71 Score on a scale
Standard Deviation 1.395
|
-1.75 Score on a scale
Standard Deviation 1.164
|
-1.86 Score on a scale
Standard Deviation 1.215
|
-1.58 Score on a scale
Standard Deviation 1.311
|
-1.53 Score on a scale
Standard Deviation 1.302
|
|
Change in IGA (Investigator Global Assessment) From Baseline (Part 2)
Week 44
|
-1.73 Score on a scale
Standard Deviation 1.348
|
-1.32 Score on a scale
Standard Deviation 1.335
|
-2.08 Score on a scale
Standard Deviation 1.084
|
-2.00 Score on a scale
Standard Deviation 1.155
|
-1.69 Score on a scale
Standard Deviation 1.447
|
-1.63 Score on a scale
Standard Deviation 1.070
|
-1.71 Score on a scale
Standard Deviation 1.113
|
-1.58 Score on a scale
Standard Deviation 1.259
|
-1.64 Score on a scale
Standard Deviation 1.393
|
|
Change in IGA (Investigator Global Assessment) From Baseline (Part 2)
Week 24
|
-2.00 Score on a scale
Standard Deviation 0.953
|
-1.82 Score on a scale
Standard Deviation 1.156
|
-2.42 Score on a scale
Standard Deviation 0.793
|
-2.31 Score on a scale
Standard Deviation 0.855
|
-1.91 Score on a scale
Standard Deviation 1.026
|
-1.82 Score on a scale
Standard Deviation 1.131
|
-2.00 Score on a scale
Standard Deviation 1.000
|
-1.73 Score on a scale
Standard Deviation 0.911
|
-1.63 Score on a scale
Standard Deviation 1.204
|
|
Change in IGA (Investigator Global Assessment) From Baseline (Part 2)
Week 28
|
-2.17 Score on a scale
Standard Deviation 1.193
|
-1.46 Score on a scale
Standard Deviation 1.138
|
-2.25 Score on a scale
Standard Deviation 0.965
|
-2.46 Score on a scale
Standard Deviation 0.967
|
-2.00 Score on a scale
Standard Deviation 1.155
|
-1.74 Score on a scale
Standard Deviation 1.064
|
-1.71 Score on a scale
Standard Deviation 0.951
|
-1.47 Score on a scale
Standard Deviation 0.961
|
-1.71 Score on a scale
Standard Deviation 1.383
|
|
Change in IGA (Investigator Global Assessment) From Baseline (Part 2)
Week 32
|
-1.73 Score on a scale
Standard Deviation 1.348
|
-1.32 Score on a scale
Standard Deviation 1.188
|
-2.33 Score on a scale
Standard Deviation 0.985
|
-2.00 Score on a scale
Standard Deviation 1.000
|
-1.82 Score on a scale
Standard Deviation 1.314
|
-1.75 Score on a scale
Standard Deviation 1.078
|
-1.71 Score on a scale
Standard Deviation 0.951
|
-1.41 Score on a scale
Standard Deviation 1.160
|
-1.67 Score on a scale
Standard Deviation 1.234
|
|
Change in IGA (Investigator Global Assessment) From Baseline (Part 2)
Week 36
|
-1.40 Score on a scale
Standard Deviation 1.174
|
-1.29 Score on a scale
Standard Deviation 1.182
|
-2.17 Score on a scale
Standard Deviation 1.115
|
-2.08 Score on a scale
Standard Deviation 1.188
|
-1.70 Score on a scale
Standard Deviation 1.380
|
-1.81 Score on a scale
Standard Deviation 1.230
|
-2.00 Score on a scale
Standard Deviation 1.000
|
-1.53 Score on a scale
Standard Deviation 1.344
|
-1.67 Score on a scale
Standard Deviation 1.234
|
|
Change in IGA (Investigator Global Assessment) From Baseline (Part 2)
Week 48
|
-1.60 Score on a scale
Standard Deviation 1.350
|
-1.36 Score on a scale
Standard Deviation 1.367
|
-2.08 Score on a scale
Standard Deviation 1.240
|
-1.69 Score on a scale
Standard Deviation 1.182
|
-1.69 Score on a scale
Standard Deviation 1.469
|
-1.50 Score on a scale
Standard Deviation 1.137
|
-2.00 Score on a scale
Standard Deviation 1.414
|
-1.63 Score on a scale
Standard Deviation 1.351
|
-1.71 Score on a scale
Standard Deviation 1.590
|
SECONDARY outcome
Timeframe: Baseline to weeks 2, 4, 8,12,16,20 & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.
The IGA is a five-point scale that provides a global clinical assessment of AD (Atopic Dermatitis) severity ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe AD
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)
Week 2
|
0 Percentage of participants
|
0 Percentage of participants
|
1.3 Percentage of participants
|
1.3 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)
Week 4
|
1.3 Percentage of participants
|
2.5 Percentage of participants
|
2.5 Percentage of participants
|
5.2 Percentage of participants
|
1.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)
Week 8
|
13.0 Percentage of participants
|
5.1 Percentage of participants
|
5.1 Percentage of participants
|
9.1 Percentage of participants
|
9.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)
Week 12
|
19.5 Percentage of participants
|
19.0 Percentage of participants
|
3.8 Percentage of participants
|
16.9 Percentage of participants
|
12.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)
Week 16
|
19.5 Percentage of participants
|
25.3 Percentage of participants
|
5.1 Percentage of participants
|
22.1 Percentage of participants
|
14.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)
Week 20
|
27.3 Percentage of participants
|
21.5 Percentage of participants
|
8.9 Percentage of participants
|
33.8 Percentage of participants
|
25.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)
Week 24
|
40.3 Percentage of participants
|
29.1 Percentage of participants
|
11.4 Percentage of participants
|
45.5 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 4, 8, 12, 16, 20 & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Week 4
|
-15.89 Score on a scale
Standard Deviation 14.865
|
-14.43 Score on a scale
Standard Deviation 13.691
|
-11.13 Score on a scale
Standard Deviation 14.243
|
-15.30 Score on a scale
Standard Deviation 16.517
|
-12.27 Score on a scale
Standard Deviation 13.455
|
—
|
—
|
—
|
—
|
|
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Week 8
|
-21.49 Score on a scale
Standard Deviation 19.200
|
-21.42 Score on a scale
Standard Deviation 16.956
|
-12.50 Score on a scale
Standard Deviation 16.584
|
-22.39 Score on a scale
Standard Deviation 19.368
|
-19.61 Score on a scale
Standard Deviation 17.527
|
—
|
—
|
—
|
—
|
|
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Week 12
|
-27.72 Score on a scale
Standard Deviation 20.084
|
-26.45 Score on a scale
Standard Deviation 19.649
|
-13.97 Score on a scale
Standard Deviation 16.898
|
-27.80 Score on a scale
Standard Deviation 19.621
|
-22.31 Score on a scale
Standard Deviation 17.936
|
—
|
—
|
—
|
—
|
|
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Week 16
|
-26.28 Score on a scale
Standard Deviation 21.258
|
-28.15 Score on a scale
Standard Deviation 19.831
|
-13.85 Score on a scale
Standard Deviation 18.123
|
-30.12 Score on a scale
Standard Deviation 20.086
|
-25.07 Score on a scale
Standard Deviation 20.233
|
—
|
—
|
—
|
—
|
|
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Week 20
|
-29.80 Score on a scale
Standard Deviation 23.594
|
-26.71 Score on a scale
Standard Deviation 21.056
|
-13.91 Score on a scale
Standard Deviation 19.325
|
-34.89 Score on a scale
Standard Deviation 22.369
|
-28.04 Score on a scale
Standard Deviation 22.472
|
—
|
—
|
—
|
—
|
|
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Week 24
|
-29.96 Score on a scale
Standard Deviation 25.735
|
-28.48 Score on a scale
Standard Deviation 21.793
|
-15.08 Score on a scale
Standard Deviation 22.739
|
-36.19 Score on a scale
Standard Deviation 24.605
|
-27.28 Score on a scale
Standard Deviation 22.937
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to week 24, 28, 32, 36, 40, 44, 48 & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24.
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 28
|
-43.38 Score on a scale
Standard Deviation 24.261
|
-33.40 Score on a scale
Standard Deviation 23.845
|
-47.15 Score on a scale
Standard Deviation 16.401
|
-54.19 Score on a scale
Standard Deviation 18.525
|
-44.30 Score on a scale
Standard Deviation 23.737
|
-43.95 Score on a scale
Standard Deviation 24.475
|
-41.17 Score on a scale
Standard Deviation 19.190
|
-37.46 Score on a scale
Standard Deviation 23.843
|
-42.98 Score on a scale
Standard Deviation 24.770
|
|
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 32
|
-37.58 Score on a scale
Standard Deviation 27.000
|
-28.31 Score on a scale
Standard Deviation 23.318
|
-50.76 Score on a scale
Standard Deviation 16.285
|
-51.19 Score on a scale
Standard Deviation 23.086
|
-41.55 Score on a scale
Standard Deviation 25.962
|
-44.04 Score on a scale
Standard Deviation 22.541
|
-40.76 Score on a scale
Standard Deviation 17.685
|
-36.72 Score on a scale
Standard Deviation 25.421
|
-37.81 Score on a scale
Standard Deviation 25.964
|
|
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 36
|
-33.91 Score on a scale
Standard Deviation 26.686
|
-27.91 Score on a scale
Standard Deviation 24.154
|
-52.12 Score on a scale
Standard Deviation 19.167
|
-49.68 Score on a scale
Standard Deviation 25.709
|
-38.72 Score on a scale
Standard Deviation 27.164
|
-45.28 Score on a scale
Standard Deviation 23.438
|
-40.09 Score on a scale
Standard Deviation 16.767
|
-37.15 Score on a scale
Standard Deviation 27.483
|
-39.35 Score on a scale
Standard Deviation 25.340
|
|
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 40
|
-36.05 Score on a scale
Standard Deviation 27.550
|
-30.05 Score on a scale
Standard Deviation 26.602
|
-52.42 Score on a scale
Standard Deviation 19.560
|
-49.88 Score on a scale
Standard Deviation 26.342
|
-38.96 Score on a scale
Standard Deviation 29.090
|
-42.93 Score on a scale
Standard Deviation 24.694
|
-45.31 Score on a scale
Standard Deviation 22.710
|
-37.75 Score on a scale
Standard Deviation 27.127
|
-36.74 Score on a scale
Standard Deviation 25.865
|
|
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 44
|
-37.95 Score on a scale
Standard Deviation 28.362
|
-29.98 Score on a scale
Standard Deviation 26.387
|
-51.14 Score on a scale
Standard Deviation 20.299
|
-47.38 Score on a scale
Standard Deviation 26.194
|
-38.61 Score on a scale
Standard Deviation 28.602
|
-40.96 Score on a scale
Standard Deviation 24.470
|
-36.39 Score on a scale
Standard Deviation 21.651
|
-36.83 Score on a scale
Standard Deviation 27.061
|
-37.47 Score on a scale
Standard Deviation 27.887
|
|
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 48
|
-35.13 Score on a scale
Standard Deviation 27.409
|
-29.71 Score on a scale
Standard Deviation 28.021
|
-52.40 Score on a scale
Standard Deviation 22.250
|
-39.75 Score on a scale
Standard Deviation 25.447
|
-38.18 Score on a scale
Standard Deviation 29.948
|
-38.38 Score on a scale
Standard Deviation 24.940
|
-43.80 Score on a scale
Standard Deviation 27.380
|
-37.64 Score on a scale
Standard Deviation 28.543
|
-38.10 Score on a scale
Standard Deviation 28.181
|
|
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 52
|
-35.04 Score on a scale
Standard Deviation 27.120
|
-29.26 Score on a scale
Standard Deviation 27.488
|
-50.26 Score on a scale
Standard Deviation 26.772
|
-40.26 Score on a scale
Standard Deviation 26.751
|
-34.69 Score on a scale
Standard Deviation 28.925
|
-37.07 Score on a scale
Standard Deviation 25.763
|
-42.26 Score on a scale
Standard Deviation 25.861
|
-38.41 Score on a scale
Standard Deviation 26.915
|
-39.94 Score on a scale
Standard Deviation 29.182
|
|
Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 24
|
-42.44 Score on a scale
Standard Deviation 21.879
|
-36.77 Score on a scale
Standard Deviation 21.919
|
-49.87 Score on a scale
Standard Deviation 13.012
|
-52.22 Score on a scale
Standard Deviation 14.314
|
-44.25 Score on a scale
Standard Deviation 21.373
|
-41.65 Score on a scale
Standard Deviation 24.173
|
-45.20 Score on a scale
Standard Deviation 18.017
|
-38.45 Score on a scale
Standard Deviation 22.077
|
-40.54 Score on a scale
Standard Deviation 23.584
|
SECONDARY outcome
Timeframe: Baseline to weeks 4, 8, 12, 16, 20, & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Week 4
|
-22.76 Percentage of change
Standard Deviation 20.903
|
-21.42 Percentage of change
Standard Deviation 21.101
|
-16.67 Percentage of change
Standard Deviation 21.045
|
-22.02 Percentage of change
Standard Deviation 22.050
|
-18.52 Percentage of change
Standard Deviation 20.315
|
—
|
—
|
—
|
—
|
|
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Week 8
|
-30.47 Percentage of change
Standard Deviation 26.260
|
-32.07 Percentage of change
Standard Deviation 23.600
|
-18.27 Percentage of change
Standard Deviation 23.875
|
-31.84 Percentage of change
Standard Deviation 24.549
|
-30.00 Percentage of change
Standard Deviation 28.050
|
—
|
—
|
—
|
—
|
|
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Week 12
|
-39.38 Percentage of change
Standard Deviation 27.228
|
-39.22 Percentage of change
Standard Deviation 26.807
|
-20.70 Percentage of change
Standard Deviation 24.587
|
-40.32 Percentage of change
Standard Deviation 25.145
|
-33.64 Percentage of change
Standard Deviation 26.502
|
—
|
—
|
—
|
—
|
|
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Week 16
|
-37.33 Percentage of change
Standard Deviation 29.071
|
-41.44 Percentage of change
Standard Deviation 26.134
|
-20.87 Percentage of change
Standard Deviation 26.791
|
-43.25 Percentage of change
Standard Deviation 26.555
|
-37.18 Percentage of change
Standard Deviation 28.395
|
—
|
—
|
—
|
—
|
|
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Week 20
|
-42.30 Percentage of change
Standard Deviation 32.422
|
-39.05 Percentage of change
Standard Deviation 28.347
|
-20.88 Percentage of change
Standard Deviation 28.527
|
-49.92 Percentage of change
Standard Deviation 28.279
|
-42.07 Percentage of change
Standard Deviation 32.179
|
—
|
—
|
—
|
—
|
|
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)
Week 24
|
-42.58 Percentage of change
Standard Deviation 35.812
|
-41.49 Percentage of change
Standard Deviation 29.263
|
-22.21 Percentage of change
Standard Deviation 33.233
|
-57.87 Percentage of change
Standard Deviation 32.609
|
-41.04 Percentage of change
Standard Deviation 34.212
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.
SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease)
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 24
|
-60.09 Percentage of change
Standard Deviation 26.373
|
-57.73 Percentage of change
Standard Deviation 34.302
|
-72.55 Percentage of change
Standard Deviation 15.422
|
-76.47 Percentage of change
Standard Deviation 11.581
|
-63.86 Percentage of change
Standard Deviation 27.005
|
-58.96 Percentage of change
Standard Deviation 31.260
|
-66.12 Percentage of change
Standard Deviation 19.532
|
-55.75 Percentage of change
Standard Deviation 26.945
|
-60.13 Percentage of change
Standard Deviation 33.848
|
|
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 28
|
-62.58 Percentage of change
Standard Deviation 32.229
|
-52.12 Percentage of change
Standard Deviation 35.950
|
-68.39 Percentage of change
Standard Deviation 21.143
|
-78.39 Percentage of change
Standard Deviation 16.236
|
-63.35 Percentage of change
Standard Deviation 28.625
|
-61.69 Percentage of change
Standard Deviation 32.214
|
-64.22 Percentage of change
Standard Deviation 18.649
|
-53.98 Percentage of change
Standard Deviation 29.707
|
-62.81 Percentage of change
Standard Deviation 36.300
|
|
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 32
|
-53.42 Percentage of change
Standard Deviation 34.955
|
-44.49 Percentage of change
Standard Deviation 35.890
|
-74.03 Percentage of change
Standard Deviation 21.589
|
-72.44 Percentage of change
Standard Deviation 25.786
|
-59.37 Percentage of change
Standard Deviation 33.889
|
-62.38 Percentage of change
Standard Deviation 31.104
|
-64.07 Percentage of change
Standard Deviation 16.853
|
-52.47 Percentage of change
Standard Deviation 31.788
|
-56.11 Percentage of change
Standard Deviation 38.003
|
|
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 36
|
-49.88 Percentage of change
Standard Deviation 36.111
|
-43.78 Percentage of change
Standard Deviation 36.278
|
-75.08 Percentage of change
Standard Deviation 21.563
|
-71.50 Percentage of change
Standard Deviation 31.364
|
-55.13 Percentage of change
Standard Deviation 35.598
|
-63.79 Percentage of change
Standard Deviation 31.710
|
-64.24 Percentage of change
Standard Deviation 20.730
|
-53.95 Percentage of change
Standard Deviation 35.053
|
-58.72 Percentage of change
Standard Deviation 36.827
|
|
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 40
|
-51.85 Percentage of change
Standard Deviation 37.053
|
-46.81 Percentage of change
Standard Deviation 39.055
|
-74.34 Percentage of change
Standard Deviation 22.474
|
-71.43 Percentage of change
Standard Deviation 31.643
|
-54.79 Percentage of change
Standard Deviation 38.533
|
-61.12 Percentage of change
Standard Deviation 34.217
|
-70.27 Percentage of change
Standard Deviation 22.037
|
-54.56 Percentage of change
Standard Deviation 34.785
|
-54.24 Percentage of change
Standard Deviation 36.614
|
|
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 44
|
-54.10 Percentage of change
Standard Deviation 37.251
|
-46.95 Percentage of change
Standard Deviation 39.736
|
-73.34 Percentage of change
Standard Deviation 22.409
|
-67.26 Percentage of change
Standard Deviation 31.749
|
-54.96 Percentage of change
Standard Deviation 38.272
|
-57.94 Percentage of change
Standard Deviation 33.953
|
-58.19 Percentage of change
Standard Deviation 33.365
|
-52.89 Percentage of change
Standard Deviation 34.032
|
-55.26 Percentage of change
Standard Deviation 39.204
|
|
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 48
|
-51.66 Percentage of change
Standard Deviation 37.347
|
-45.48 Percentage of change
Standard Deviation 41.426
|
-74.37 Percentage of change
Standard Deviation 23.066
|
-59.99 Percentage of change
Standard Deviation 35.979
|
-53.71 Percentage of change
Standard Deviation 39.548
|
-54.55 Percentage of change
Standard Deviation 34.719
|
-67.92 Percentage of change
Standard Deviation 35.766
|
-54.29 Percentage of change
Standard Deviation 35.851
|
-56.30 Percentage of change
Standard Deviation 39.696
|
|
Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)
Week 52
|
-49.68 Percentage of change
Standard Deviation 35.129
|
-44.93 Percentage of change
Standard Deviation 40.527
|
-69.62 Percentage of change
Standard Deviation 29.104
|
-60.41 Percentage of change
Standard Deviation 36.686
|
-49.90 Percentage of change
Standard Deviation 40.104
|
-52.47 Percentage of change
Standard Deviation 35.396
|
-65.97 Percentage of change
Standard Deviation 34.709
|
-56.19 Percentage of change
Standard Deviation 34.460
|
-58.86 Percentage of change
Standard Deviation 40.701
|
SECONDARY outcome
Timeframe: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)
Week 2
|
-9.08 Percentage of body surface area
Standard Deviation 15.999
|
-7.41 Percentage of body surface area
Standard Deviation 12.588
|
-4.84 Percentage of body surface area
Standard Deviation 9.113
|
-4.50 Percentage of body surface area
Standard Deviation 10.610
|
-5.61 Percentage of body surface area
Standard Deviation 10.165
|
—
|
—
|
—
|
—
|
|
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)
Week 4
|
-13.34 Percentage of body surface area
Standard Deviation 17.347
|
-12.51 Percentage of body surface area
Standard Deviation 16.318
|
-9.67 Percentage of body surface area
Standard Deviation 16.941
|
-12.83 Percentage of body surface area
Standard Deviation 15.922
|
-10.16 Percentage of body surface area
Standard Deviation 12.917
|
—
|
—
|
—
|
—
|
|
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)
Week 8
|
-17.55 Percentage of body surface area
Standard Deviation 21.064
|
-19.11 Percentage of body surface area
Standard Deviation 18.253
|
-10.00 Percentage of body surface area
Standard Deviation 17.375
|
-19.37 Percentage of body surface area
Standard Deviation 18.857
|
-15.77 Percentage of body surface area
Standard Deviation 17.004
|
—
|
—
|
—
|
—
|
|
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)
Week 12
|
-21.94 Percentage of body surface area
Standard Deviation 22.715
|
-24.14 Percentage of body surface area
Standard Deviation 19.903
|
-11.46 Percentage of body surface area
Standard Deviation 17.035
|
-24.13 Percentage of body surface area
Standard Deviation 18.097
|
-19.54 Percentage of body surface area
Standard Deviation 19.578
|
—
|
—
|
—
|
—
|
|
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)
Week 16
|
-21.74 Percentage of body surface area
Standard Deviation 24.799
|
-26.04 Percentage of body surface area
Standard Deviation 20.403
|
-8.87 Percentage of body surface area
Standard Deviation 16.956
|
-26.91 Percentage of body surface area
Standard Deviation 20.286
|
-22.71 Percentage of body surface area
Standard Deviation 21.966
|
—
|
—
|
—
|
—
|
|
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)
Week 20
|
-24.35 Percentage of body surface area
Standard Deviation 26.238
|
-24.63 Percentage of body surface area
Standard Deviation 21.263
|
-11.04 Percentage of body surface area
Standard Deviation 19.653
|
-30.25 Percentage of body surface area
Standard Deviation 21.850
|
-23.33 Percentage of body surface area
Standard Deviation 22.600
|
—
|
—
|
—
|
—
|
|
Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)
Week 24
|
-22.66 Percentage of body surface area
Standard Deviation 27.317
|
-25.77 Percentage of body surface area
Standard Deviation 22.085
|
-10.45 Percentage of body surface area
Standard Deviation 20.837
|
-31.35 Percentage of body surface area
Standard Deviation 22.434
|
-21.82 Percentage of body surface area
Standard Deviation 21.882
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change in Affected BSA From Baseline (Part 2)
Week 24
|
-37.17 Percentage of body surface area
Standard Deviation 17.994
|
-28.14 Percentage of body surface area
Standard Deviation 21.790
|
-41.17 Percentage of body surface area
Standard Deviation 22.982
|
-46.92 Percentage of body surface area
Standard Deviation 22.009
|
-37.94 Percentage of body surface area
Standard Deviation 18.723
|
-33.81 Percentage of body surface area
Standard Deviation 26.454
|
-40.60 Percentage of body surface area
Standard Deviation 26.006
|
-34.30 Percentage of body surface area
Standard Deviation 19.787
|
-32.06 Percentage of body surface area
Standard Deviation 22.831
|
|
Absolute Change in Affected BSA From Baseline (Part 2)
Week 28
|
-35.92 Percentage of body surface area
Standard Deviation 20.804
|
-25.54 Percentage of body surface area
Standard Deviation 22.718
|
-40.00 Percentage of body surface area
Standard Deviation 23.394
|
-48.69 Percentage of body surface area
Standard Deviation 23.329
|
-38.68 Percentage of body surface area
Standard Deviation 20.582
|
-35.61 Percentage of body surface area
Standard Deviation 25.720
|
-37.14 Percentage of body surface area
Standard Deviation 23.801
|
-33.62 Percentage of body surface area
Standard Deviation 19.692
|
-36.00 Percentage of body surface area
Standard Deviation 24.553
|
|
Absolute Change in Affected BSA From Baseline (Part 2)
Week 32
|
-29.64 Percentage of body surface area
Standard Deviation 25.590
|
-23.21 Percentage of body surface area
Standard Deviation 23.710
|
-42.08 Percentage of body surface area
Standard Deviation 22.685
|
-47.15 Percentage of body surface area
Standard Deviation 25.271
|
-36.62 Percentage of body surface area
Standard Deviation 23.049
|
-35.94 Percentage of body surface area
Standard Deviation 26.193
|
-38.00 Percentage of body surface area
Standard Deviation 23.847
|
-32.13 Percentage of body surface area
Standard Deviation 21.515
|
-30.07 Percentage of body surface area
Standard Deviation 22.861
|
|
Absolute Change in Affected BSA From Baseline (Part 2)
Week 36
|
-28.30 Percentage of body surface area
Standard Deviation 26.437
|
-22.21 Percentage of body surface area
Standard Deviation 23.857
|
-41.67 Percentage of body surface area
Standard Deviation 23.051
|
-46.00 Percentage of body surface area
Standard Deviation 26.242
|
-33.61 Percentage of body surface area
Standard Deviation 24.187
|
-35.75 Percentage of body surface area
Standard Deviation 25.664
|
-37.86 Percentage of body surface area
Standard Deviation 24.674
|
-30.91 Percentage of body surface area
Standard Deviation 24.288
|
-31.27 Percentage of body surface area
Standard Deviation 24.391
|
|
Absolute Change in Affected BSA From Baseline (Part 2)
Week 40
|
-29.18 Percentage of body surface area
Standard Deviation 24.774
|
-22.57 Percentage of body surface area
Standard Deviation 23.841
|
-41.45 Percentage of body surface area
Standard Deviation 23.729
|
-46.62 Percentage of body surface area
Standard Deviation 26.314
|
-32.94 Percentage of body surface area
Standard Deviation 24.589
|
-33.41 Percentage of body surface area
Standard Deviation 22.649
|
-39.57 Percentage of body surface area
Standard Deviation 24.758
|
-32.00 Percentage of body surface area
Standard Deviation 23.697
|
-31.27 Percentage of body surface area
Standard Deviation 24.566
|
|
Absolute Change in Affected BSA From Baseline (Part 2)
Week 44
|
-29.73 Percentage of body surface area
Standard Deviation 25.503
|
-22.21 Percentage of body surface area
Standard Deviation 23.706
|
-42.17 Percentage of body surface area
Standard Deviation 25.283
|
-47.23 Percentage of body surface area
Standard Deviation 26.540
|
-33.22 Percentage of body surface area
Standard Deviation 24.143
|
-31.91 Percentage of body surface area
Standard Deviation 22.069
|
-34.43 Percentage of body surface area
Standard Deviation 25.172
|
-32.23 Percentage of body surface area
Standard Deviation 23.250
|
-27.43 Percentage of body surface area
Standard Deviation 20.478
|
|
Absolute Change in Affected BSA From Baseline (Part 2)
Week 48
|
-28.30 Percentage of body surface area
Standard Deviation 26.378
|
-21.50 Percentage of body surface area
Standard Deviation 24.053
|
-42.92 Percentage of body surface area
Standard Deviation 25.336
|
-35.69 Percentage of body surface area
Standard Deviation 26.183
|
-32.72 Percentage of body surface area
Standard Deviation 25.358
|
-30.53 Percentage of body surface area
Standard Deviation 23.544
|
-36.43 Percentage of body surface area
Standard Deviation 21.141
|
-31.13 Percentage of body surface area
Standard Deviation 26.208
|
-26.93 Percentage of body surface area
Standard Deviation 20.775
|
|
Absolute Change in Affected BSA From Baseline (Part 2)
Week 52
|
-29.55 Percentage of body surface area
Standard Deviation 25.359
|
-21.46 Percentage of body surface area
Standard Deviation 23.562
|
-45.09 Percentage of body surface area
Standard Deviation 25.770
|
-35.54 Percentage of body surface area
Standard Deviation 26.384
|
-29.48 Percentage of body surface area
Standard Deviation 22.232
|
-29.66 Percentage of body surface area
Standard Deviation 23.818
|
-34.71 Percentage of body surface area
Standard Deviation 18.688
|
-33.33 Percentage of body surface area
Standard Deviation 22.702
|
-27.21 Percentage of body surface area
Standard Deviation 20.955
|
SECONDARY outcome
Timeframe: Baseline to weeks 2, 4, 8, 12, 16, 20, & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in Affected BSA From Baseline (Part 1)
Week 2
|
-19.43 Percentage change
Standard Deviation 30.139
|
-15.06 Percentage change
Standard Deviation 37.312
|
-11.45 Percentage change
Standard Deviation 22.767
|
-10.11 Percentage change
Standard Deviation 24.013
|
-12.23 Percentage change
Standard Deviation 26.053
|
—
|
—
|
—
|
—
|
|
Percentage Change in Affected BSA From Baseline (Part 1)
Week 4
|
-29.46 Percentage change
Standard Deviation 32.934
|
-28.84 Percentage change
Standard Deviation 38.412
|
-20.92 Percentage change
Standard Deviation 38.260
|
-26.45 Percentage change
Standard Deviation 28.733
|
-23.44 Percentage change
Standard Deviation 28.941
|
—
|
—
|
—
|
—
|
|
Percentage Change in Affected BSA From Baseline (Part 1)
Week 8
|
-37.60 Percentage change
Standard Deviation 36.988
|
-42.84 Percentage change
Standard Deviation 33.931
|
-21.24 Percentage change
Standard Deviation 40.914
|
-39.12 Percentage change
Standard Deviation 31.915
|
-36.01 Percentage change
Standard Deviation 35.268
|
—
|
—
|
—
|
—
|
|
Percentage Change in Affected BSA From Baseline (Part 1)
Week 12
|
-47.04 Percentage change
Standard Deviation 40.519
|
-52.16 Percentage change
Standard Deviation 35.736
|
-26.56 Percentage change
Standard Deviation 36.705
|
-49.88 Percentage change
Standard Deviation 29.737
|
-43.68 Percentage change
Standard Deviation 38.140
|
—
|
—
|
—
|
—
|
|
Percentage Change in Affected BSA From Baseline (Part 1)
Week 16
|
-46.35 Percentage change
Standard Deviation 43.511
|
-56.36 Percentage change
Standard Deviation 35.593
|
-22.37 Percentage change
Standard Deviation 40.483
|
-54.58 Percentage change
Standard Deviation 32.206
|
-49.44 Percentage change
Standard Deviation 40.861
|
—
|
—
|
—
|
—
|
|
Percentage Change in Affected BSA From Baseline (Part 1)
Week 20
|
-50.36 Percentage change
Standard Deviation 45.871
|
-53.55 Percentage change
Standard Deviation 42.762
|
-25.46 Percentage change
Standard Deviation 42.034
|
-59.75 Percentage change
Standard Deviation 33.804
|
-51.07 Percentage change
Standard Deviation 42.023
|
—
|
—
|
—
|
—
|
|
Percentage Change in Affected BSA From Baseline (Part 1)
Week 24
|
-48.11 Percentage change
Standard Deviation 48.748
|
-52.94 Percentage change
Standard Deviation 44.872
|
-23.76 Percentage change
Standard Deviation 44.394
|
-63.02 Percentage change
Standard Deviation 36.184
|
-49.42 Percentage change
Standard Deviation 43.012
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in Affected BSA From Baseline (Part 2)
Week 24
|
-80.67 Percentage change
Standard Deviation 27.843
|
-67.85 Percentage change
Standard Deviation 39.902
|
-85.29 Percentage change
Standard Deviation 19.008
|
-88.09 Percentage change
Standard Deviation 12.983
|
-78.75 Percentage change
Standard Deviation 27.966
|
-71.05 Percentage change
Standard Deviation 39.900
|
-80.52 Percentage change
Standard Deviation 14.717
|
-74.02 Percentage change
Standard Deviation 31.419
|
-72.91 Percentage change
Standard Deviation 34.317
|
|
Percentage Change in Affected BSA From Baseline (Part 2)
Week 28
|
-76.55 Percentage change
Standard Deviation 35.680
|
-62.09 Percentage change
Standard Deviation 42.748
|
-81.75 Percentage change
Standard Deviation 24.996
|
-90.51 Percentage change
Standard Deviation 10.816
|
-79.51 Percentage change
Standard Deviation 29.501
|
-73.28 Percentage change
Standard Deviation 40.454
|
-88.57 Percentage change
Standard Deviation 5.800
|
-72.98 Percentage change
Standard Deviation 30.947
|
-75.14 Percentage change
Standard Deviation 37.955
|
|
Percentage Change in Affected BSA From Baseline (Part 2)
Week 32
|
-65.07 Percentage change
Standard Deviation 49.743
|
-55.89 Percentage change
Standard Deviation 45.768
|
-86.34 Percentage change
Standard Deviation 18.724
|
-83.58 Percentage change
Standard Deviation 23.940
|
-75.09 Percentage change
Standard Deviation 36.907
|
-74.61 Percentage change
Standard Deviation 40.429
|
-90.31 Percentage change
Standard Deviation 10.263
|
-66.90 Percentage change
Standard Deviation 35.357
|
-69.74 Percentage change
Standard Deviation 38.644
|
|
Percentage Change in Affected BSA From Baseline (Part 2)
Week 36
|
-61.93 Percentage change
Standard Deviation 51.222
|
-53.48 Percentage change
Standard Deviation 45.933
|
-85.33 Percentage change
Standard Deviation 18.348
|
-81.56 Percentage change
Standard Deviation 27.924
|
-68.81 Percentage change
Standard Deviation 40.261
|
-74.73 Percentage change
Standard Deviation 40.570
|
-89.70 Percentage change
Standard Deviation 10.552
|
-63.85 Percentage change
Standard Deviation 46.152
|
-72.34 Percentage change
Standard Deviation 39.621
|
|
Percentage Change in Affected BSA From Baseline (Part 2)
Week 40
|
-64.54 Percentage change
Standard Deviation 49.422
|
-54.92 Percentage change
Standard Deviation 47.035
|
-86.81 Percentage change
Standard Deviation 17.237
|
-82.62 Percentage change
Standard Deviation 28.019
|
-66.33 Percentage change
Standard Deviation 41.876
|
-72.10 Percentage change
Standard Deviation 41.016
|
-94.09 Percentage change
Standard Deviation 5.083
|
-66.00 Percentage change
Standard Deviation 43.207
|
-72.08 Percentage change
Standard Deviation 39.691
|
|
Percentage Change in Affected BSA From Baseline (Part 2)
Week 44
|
-65.39 Percentage change
Standard Deviation 49.945
|
-53.82 Percentage change
Standard Deviation 46.414
|
-84.47 Percentage change
Standard Deviation 24.104
|
-83.52 Percentage change
Standard Deviation 28.118
|
-66.91 Percentage change
Standard Deviation 41.122
|
-69.38 Percentage change
Standard Deviation 41.133
|
-81.11 Percentage change
Standard Deviation 19.107
|
-66.54 Percentage change
Standard Deviation 41.241
|
-70.30 Percentage change
Standard Deviation 40.560
|
|
Percentage Change in Affected BSA From Baseline (Part 2)
Week 48
|
-62.01 Percentage change
Standard Deviation 51.359
|
-52.52 Percentage change
Standard Deviation 47.479
|
-85.70 Percentage change
Standard Deviation 19.040
|
-69.37 Percentage change
Standard Deviation 40.195
|
-64.74 Percentage change
Standard Deviation 42.092
|
-64.73 Percentage change
Standard Deviation 42.700
|
-87.79 Percentage change
Standard Deviation 16.209
|
-62.58 Percentage change
Standard Deviation 48.827
|
-68.01 Percentage change
Standard Deviation 40.428
|
|
Percentage Change in Affected BSA From Baseline (Part 2)
Week 52
|
-64.90 Percentage change
Standard Deviation 49.605
|
-52.82 Percentage change
Standard Deviation 47.733
|
-89.06 Percentage change
Standard Deviation 14.176
|
-68.90 Percentage change
Standard Deviation 40.301
|
-61.59 Percentage change
Standard Deviation 42.339
|
-62.25 Percentage change
Standard Deviation 42.451
|
-85.46 Percentage change
Standard Deviation 16.921
|
-68.75 Percentage change
Standard Deviation 39.935
|
-68.78 Percentage change
Standard Deviation 41.236
|
SECONDARY outcome
Timeframe: Baseline to weeks 4, 8, 12, 16, 20, & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Week 4
|
-5.42 Score on a scale
Standard Deviation 6.498
|
-4.08 Score on a scale
Standard Deviation 5.448
|
-2.32 Score on a scale
Standard Deviation 5.910
|
-4.40 Score on a scale
Standard Deviation 6.403
|
-4.01 Score on a scale
Standard Deviation 6.287
|
—
|
—
|
—
|
—
|
|
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Week 8
|
-5.70 Score on a scale
Standard Deviation 6.943
|
-6.75 Score on a scale
Standard Deviation 6.646
|
-2.13 Score on a scale
Standard Deviation 6.400
|
-7.03 Score on a scale
Standard Deviation 6.869
|
-5.13 Score on a scale
Standard Deviation 7.093
|
—
|
—
|
—
|
—
|
|
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Week 12
|
-7.29 Score on a scale
Standard Deviation 7.216
|
-7.36 Score on a scale
Standard Deviation 7.460
|
-2.26 Score on a scale
Standard Deviation 6.088
|
-7.87 Score on a scale
Standard Deviation 7.286
|
-6.50 Score on a scale
Standard Deviation 7.229
|
—
|
—
|
—
|
—
|
|
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Week 16
|
-7.19 Score on a scale
Standard Deviation 7.720
|
-7.32 Score on a scale
Standard Deviation 7.017
|
-2.37 Score on a scale
Standard Deviation 6.867
|
-8.28 Score on a scale
Standard Deviation 7.286
|
-7.23 Score on a scale
Standard Deviation 7.744
|
—
|
—
|
—
|
—
|
|
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Week 20
|
-8.10 Score on a scale
Standard Deviation 8.150
|
-7.39 Score on a scale
Standard Deviation 7.721
|
-2.33 Score on a scale
Standard Deviation 6.821
|
-9.39 Score on a scale
Standard Deviation 7.577
|
-7.13 Score on a scale
Standard Deviation 8.662
|
—
|
—
|
—
|
—
|
|
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Week 24
|
-7.86 Score on a scale
Standard Deviation 8.572
|
-7.64 Score on a scale
Standard Deviation 7.011
|
-2.19 Score on a scale
Standard Deviation 7.310
|
-9.96 Score on a scale
Standard Deviation 7.888
|
-7.21 Score on a scale
Standard Deviation 8.213
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 32, 36, 40, 44, 48 & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Week 44
|
-10.45 Score on a scale
Standard Deviation 6.699
|
-6.50 Score on a scale
Standard Deviation 8.804
|
-11.92 Score on a scale
Standard Deviation 8.262
|
-13.31 Score on a scale
Standard Deviation 8.460
|
-9.81 Score on a scale
Standard Deviation 8.920
|
-10.19 Score on a scale
Standard Deviation 8.361
|
-7.86 Score on a scale
Standard Deviation 7.515
|
-8.71 Score on a scale
Standard Deviation 8.158
|
-7.93 Score on a scale
Standard Deviation 7.908
|
|
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Week 48
|
-11.50 Score on a scale
Standard Deviation 6.916
|
-7.50 Score on a scale
Standard Deviation 9.268
|
-11.75 Score on a scale
Standard Deviation 9.836
|
-11.69 Score on a scale
Standard Deviation 9.861
|
-10.39 Score on a scale
Standard Deviation 8.519
|
-10.33 Score on a scale
Standard Deviation 8.125
|
-9.57 Score on a scale
Standard Deviation 9.126
|
-9.90 Score on a scale
Standard Deviation 8.660
|
-7.50 Score on a scale
Standard Deviation 8.438
|
|
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Week 52
|
-11.36 Score on a scale
Standard Deviation 6.889
|
-6.82 Score on a scale
Standard Deviation 9.318
|
-10.64 Score on a scale
Standard Deviation 10.053
|
-11.85 Score on a scale
Standard Deviation 10.148
|
-9.13 Score on a scale
Standard Deviation 8.320
|
-8.55 Score on a scale
Standard Deviation 8.240
|
-10.00 Score on a scale
Standard Deviation 9.452
|
-8.58 Score on a scale
Standard Deviation 9.164
|
-8.50 Score on a scale
Standard Deviation 9.146
|
|
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Week 24
|
-11.58 Score on a scale
Standard Deviation 8.586
|
-9.25 Score on a scale
Standard Deviation 8.347
|
-11.75 Score on a scale
Standard Deviation 7.086
|
-15.31 Score on a scale
Standard Deviation 6.061
|
-11.97 Score on a scale
Standard Deviation 6.410
|
-10.42 Score on a scale
Standard Deviation 7.580
|
-14.00 Score on a scale
Standard Deviation 6.205
|
-9.45 Score on a scale
Standard Deviation 7.155
|
-8.75 Score on a scale
Standard Deviation 7.197
|
|
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Week 32
|
-11.91 Score on a scale
Standard Deviation 8.240
|
-6.79 Score on a scale
Standard Deviation 8.875
|
-12.83 Score on a scale
Standard Deviation 7.082
|
-14.69 Score on a scale
Standard Deviation 8.499
|
-10.23 Score on a scale
Standard Deviation 8.320
|
-11.32 Score on a scale
Standard Deviation 8.113
|
-11.29 Score on a scale
Standard Deviation 10.323
|
-9.42 Score on a scale
Standard Deviation 7.784
|
-7.62 Score on a scale
Standard Deviation 8.856
|
|
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Week 36
|
-11.90 Score on a scale
Standard Deviation 7.264
|
-7.00 Score on a scale
Standard Deviation 8.932
|
-13.00 Score on a scale
Standard Deviation 7.019
|
-13.23 Score on a scale
Standard Deviation 8.738
|
-9.91 Score on a scale
Standard Deviation 8.129
|
-11.75 Score on a scale
Standard Deviation 8.370
|
-12.57 Score on a scale
Standard Deviation 9.502
|
-8.66 Score on a scale
Standard Deviation 7.790
|
-7.93 Score on a scale
Standard Deviation 7.966
|
|
Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Week 40
|
-11.00 Score on a scale
Standard Deviation 6.633
|
-7.82 Score on a scale
Standard Deviation 9.302
|
-11.73 Score on a scale
Standard Deviation 8.162
|
-13.92 Score on a scale
Standard Deviation 8.411
|
-9.10 Score on a scale
Standard Deviation 8.715
|
-11.88 Score on a scale
Standard Deviation 8.698
|
-11.29 Score on a scale
Standard Deviation 8.995
|
-8.81 Score on a scale
Standard Deviation 8.300
|
-7.50 Score on a scale
Standard Deviation 7.714
|
SECONDARY outcome
Timeframe: Baseline to weeks 4, 8, 12, 16, 20, & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Week 4
|
-22.77 Percentage of change
Standard Deviation 30.783
|
-17.94 Percentage of change
Standard Deviation 30.152
|
-8.99 Percentage of change
Standard Deviation 39.554
|
-20.81 Percentage of change
Standard Deviation 34.179
|
-21.02 Percentage of change
Standard Deviation 31.360
|
—
|
—
|
—
|
—
|
|
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Week 8
|
-26.62 Percentage of change
Standard Deviation 34.946
|
-34.60 Percentage of change
Standard Deviation 31.584
|
-6.28 Percentage of change
Standard Deviation 42.851
|
-33.06 Percentage of change
Standard Deviation 41.272
|
-26.52 Percentage of change
Standard Deviation 33.397
|
—
|
—
|
—
|
—
|
|
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Week 12
|
-33.33 Percentage of change
Standard Deviation 33.732
|
-34.61 Percentage of change
Standard Deviation 34.275
|
-8.04 Percentage of change
Standard Deviation 41.445
|
-36.22 Percentage of change
Standard Deviation 43.169
|
-32.42 Percentage of change
Standard Deviation 32.145
|
—
|
—
|
—
|
—
|
|
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Week 16
|
-32.78 Percentage of change
Standard Deviation 36.449
|
-35.49 Percentage of change
Standard Deviation 32.862
|
-8.12 Percentage of change
Standard Deviation 45.515
|
-37.08 Percentage of change
Standard Deviation 52.391
|
-34.71 Percentage of change
Standard Deviation 34.574
|
—
|
—
|
—
|
—
|
|
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Week 20
|
-37.38 Percentage of change
Standard Deviation 38.448
|
-35.37 Percentage of change
Standard Deviation 36.589
|
-8.32 Percentage of change
Standard Deviation 44.942
|
-44.03 Percentage of change
Standard Deviation 38.850
|
-34.23 Percentage of change
Standard Deviation 38.938
|
—
|
—
|
—
|
—
|
|
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)
Week 24
|
-36.65 Percentage of change
Standard Deviation 40.947
|
-36.81 Percentage of change
Standard Deviation 34.444
|
-6.98 Percentage of change
Standard Deviation 49.837
|
-44.69 Percentage of change
Standard Deviation 61.808
|
-33.91 Percentage of change
Standard Deviation 48.273
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 32, 36, 40. 44, 48, & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified timepoints are reported.
POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Week 24
|
-54.05 Percentage of change
Standard Deviation 38.147
|
-46.08 Percentage of change
Standard Deviation 37.356
|
-60.03 Percentage of change
Standard Deviation 30.545
|
-72.61 Percentage of change
Standard Deviation 19.898
|
-61.00 Percentage of change
Standard Deviation 30.657
|
-51.61 Percentage of change
Standard Deviation 35.438
|
-64.00 Percentage of change
Standard Deviation 20.049
|
-45.63 Percentage of change
Standard Deviation 34.579
|
-47.92 Percentage of change
Standard Deviation 40.572
|
|
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Week 32
|
-56.00 Percentage of change
Standard Deviation 35.875
|
-30.61 Percentage of change
Standard Deviation 39.689
|
-64.21 Percentage of change
Standard Deviation 28.981
|
-64.90 Percentage of change
Standard Deviation 38.029
|
-50.03 Percentage of change
Standard Deviation 44.543
|
-55.82 Percentage of change
Standard Deviation 36.229
|
-47.30 Percentage of change
Standard Deviation 57.463
|
-46.42 Percentage of change
Standard Deviation 38.011
|
-43.95 Percentage of change
Standard Deviation 50.962
|
|
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Week 36
|
-57.09 Percentage of change
Standard Deviation 34.068
|
-33.73 Percentage of change
Standard Deviation 38.724
|
-66.78 Percentage of change
Standard Deviation 27.084
|
-60.09 Percentage of change
Standard Deviation 40.508
|
-48.61 Percentage of change
Standard Deviation 43.883
|
-57.38 Percentage of change
Standard Deviation 37.436
|
-57.54 Percentage of change
Standard Deviation 59.987
|
-43.35 Percentage of change
Standard Deviation 40.000
|
-44.58 Percentage of change
Standard Deviation 45.387
|
|
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Week 40
|
-54.47 Percentage of change
Standard Deviation 35.815
|
-37.89 Percentage of change
Standard Deviation 40.032
|
-58.98 Percentage of change
Standard Deviation 33.289
|
-62.85 Percentage of change
Standard Deviation 38.659
|
-44.35 Percentage of change
Standard Deviation 45.524
|
-58.12 Percentage of change
Standard Deviation 38.754
|
-49.79 Percentage of change
Standard Deviation 55.862
|
-43.75 Percentage of change
Standard Deviation 40.933
|
-42.88 Percentage of change
Standard Deviation 45.567
|
|
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Week 44
|
-52.24 Percentage of change
Standard Deviation 36.218
|
-30.25 Percentage of change
Standard Deviation 43.110
|
-59.17 Percentage of change
Standard Deviation 35.572
|
-60.83 Percentage of change
Standard Deviation 40.648
|
-48.48 Percentage of change
Standard Deviation 47.524
|
-50.10 Percentage of change
Standard Deviation 37.814
|
-36.09 Percentage of change
Standard Deviation 53.637
|
-43.16 Percentage of change
Standard Deviation 39.688
|
-46.19 Percentage of change
Standard Deviation 46.429
|
|
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Week 48
|
-55.93 Percentage of change
Standard Deviation 35.043
|
-35.37 Percentage of change
Standard Deviation 42.309
|
-58.18 Percentage of change
Standard Deviation 46.077
|
-54.56 Percentage of change
Standard Deviation 46.380
|
-51.53 Percentage of change
Standard Deviation 44.857
|
-51.56 Percentage of change
Standard Deviation 39.299
|
-44.04 Percentage of change
Standard Deviation 58.904
|
-50.45 Percentage of change
Standard Deviation 41.809
|
-43.48 Percentage of change
Standard Deviation 48.292
|
|
Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)
Week 52
|
-54.47 Percentage of change
Standard Deviation 34.319
|
-29.38 Percentage of change
Standard Deviation 46.373
|
-52.64 Percentage of change
Standard Deviation 47.556
|
-54.68 Percentage of change
Standard Deviation 45.987
|
-44.51 Percentage of change
Standard Deviation 43.725
|
-43.45 Percentage of change
Standard Deviation 42.459
|
-48.82 Percentage of change
Standard Deviation 63.478
|
-43.01 Percentage of change
Standard Deviation 45.577
|
-47.62 Percentage of change
Standard Deviation 50.785
|
SECONDARY outcome
Timeframe: Baseline to weeks 2, 8, 16, 20, & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified timepoints are reported.
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1)
Week 2
|
-3.32 Score on a scale
Standard Deviation 5.745
|
-3.40 Score on a scale
Standard Deviation 5.131
|
-2.09 Score on a scale
Standard Deviation 4.710
|
-3.63 Score on a scale
Standard Deviation 4.992
|
-2.82 Score on a scale
Standard Deviation 4.850
|
—
|
—
|
—
|
—
|
|
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1)
Week 8
|
-5.08 Score on a scale
Standard Deviation 7.252
|
-7.13 Score on a scale
Standard Deviation 5.954
|
-2.43 Score on a scale
Standard Deviation 5.466
|
-6.13 Score on a scale
Standard Deviation 6.164
|
-5.59 Score on a scale
Standard Deviation 5.553
|
—
|
—
|
—
|
—
|
|
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1)
Week 16
|
-6.47 Score on a scale
Standard Deviation 7.835
|
-7.76 Score on a scale
Standard Deviation 6.265
|
-2.35 Score on a scale
Standard Deviation 6.069
|
-7.79 Score on a scale
Standard Deviation 6.832
|
-6.25 Score on a scale
Standard Deviation 6.246
|
—
|
—
|
—
|
—
|
|
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1)
Week 20
|
-6.97 Score on a scale
Standard Deviation 8.512
|
-7.31 Score on a scale
Standard Deviation 7.132
|
-2.39 Score on a scale
Standard Deviation 6.391
|
-7.89 Score on a scale
Standard Deviation 6.848
|
-6.42 Score on a scale
Standard Deviation 6.833
|
—
|
—
|
—
|
—
|
|
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Parts 1)
Week 24
|
-6.74 Score on a scale
Standard Deviation 8.681
|
-7.69 Score on a scale
Standard Deviation 7.230
|
-2.30 Score on a scale
Standard Deviation 6.406
|
-8.33 Score on a scale
Standard Deviation 7.036
|
-6.54 Score on a scale
Standard Deviation 6.384
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 24
|
-9.08 Score on a scale
Standard Deviation 6.487
|
-7.57 Score on a scale
Standard Deviation 7.295
|
-11.42 Score on a scale
Standard Deviation 7.115
|
-12.54 Score on a scale
Standard Deviation 6.703
|
-9.00 Score on a scale
Standard Deviation 6.290
|
-8.26 Score on a scale
Standard Deviation 9.338
|
-15.40 Score on a scale
Standard Deviation 8.562
|
-9.67 Score on a scale
Standard Deviation 7.712
|
-6.44 Score on a scale
Standard Deviation 7.420
|
|
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 28
|
-9.83 Score on a scale
Standard Deviation 6.658
|
-7.21 Score on a scale
Standard Deviation 6.488
|
-11.33 Score on a scale
Standard Deviation 7.832
|
-12.62 Score on a scale
Standard Deviation 8.191
|
-9.52 Score on a scale
Standard Deviation 6.929
|
-8.45 Score on a scale
Standard Deviation 9.705
|
-12.29 Score on a scale
Standard Deviation 9.232
|
-9.68 Score on a scale
Standard Deviation 8.029
|
-5.77 Score on a scale
Standard Deviation 8.633
|
|
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 32
|
-8.55 Score on a scale
Standard Deviation 8.238
|
-5.75 Score on a scale
Standard Deviation 7.183
|
-12.25 Score on a scale
Standard Deviation 7.700
|
-12.38 Score on a scale
Standard Deviation 8.272
|
-8.00 Score on a scale
Standard Deviation 7.612
|
-8.50 Score on a scale
Standard Deviation 9.629
|
-13.14 Score on a scale
Standard Deviation 8.050
|
-9.13 Score on a scale
Standard Deviation 7.906
|
-5.47 Score on a scale
Standard Deviation 7.963
|
|
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 36
|
-7.90 Score on a scale
Standard Deviation 6.903
|
-6.18 Score on a scale
Standard Deviation 7.222
|
-12.58 Score on a scale
Standard Deviation 7.716
|
-11.85 Score on a scale
Standard Deviation 8.122
|
-7.72 Score on a scale
Standard Deviation 7.985
|
-8.84 Score on a scale
Standard Deviation 9.893
|
-14.00 Score on a scale
Standard Deviation 8.446
|
-8.53 Score on a scale
Standard Deviation 7.927
|
-5.93 Score on a scale
Standard Deviation 7.839
|
|
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 40
|
-7.18 Score on a scale
Standard Deviation 5.456
|
-6.21 Score on a scale
Standard Deviation 7.279
|
-11.27 Score on a scale
Standard Deviation 7.976
|
-12.23 Score on a scale
Standard Deviation 7.715
|
-7.07 Score on a scale
Standard Deviation 8.073
|
-8.06 Score on a scale
Standard Deviation 9.844
|
-14.57 Score on a scale
Standard Deviation 7.569
|
-8.23 Score on a scale
Standard Deviation 8.281
|
-5.36 Score on a scale
Standard Deviation 8.308
|
|
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 44
|
-8.18 Score on a scale
Standard Deviation 6.258
|
-5.68 Score on a scale
Standard Deviation 7.029
|
-12.08 Score on a scale
Standard Deviation 8.426
|
-11.38 Score on a scale
Standard Deviation 8.109
|
-7.19 Score on a scale
Standard Deviation 7.943
|
-6.88 Score on a scale
Standard Deviation 9.587
|
-10.29 Score on a scale
Standard Deviation 7.889
|
-8.26 Score on a scale
Standard Deviation 8.058
|
-5.93 Score on a scale
Standard Deviation 6.889
|
|
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 48
|
-8.40 Score on a scale
Standard Deviation 7.516
|
-6.21 Score on a scale
Standard Deviation 7.218
|
-11.92 Score on a scale
Standard Deviation 8.229
|
-9.92 Score on a scale
Standard Deviation 6.800
|
-7.29 Score on a scale
Standard Deviation 8.022
|
-6.83 Score on a scale
Standard Deviation 9.322
|
-11.29 Score on a scale
Standard Deviation 6.237
|
-7.93 Score on a scale
Standard Deviation 7.891
|
-6.79 Score on a scale
Standard Deviation 7.040
|
|
Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 52
|
-8.09 Score on a scale
Standard Deviation 7.077
|
-5.93 Score on a scale
Standard Deviation 7.383
|
-12.55 Score on a scale
Standard Deviation 9.136
|
-9.08 Score on a scale
Standard Deviation 6.652
|
-6.83 Score on a scale
Standard Deviation 7.852
|
-6.41 Score on a scale
Standard Deviation 9.428
|
-11.57 Score on a scale
Standard Deviation 6.705
|
-8.10 Score on a scale
Standard Deviation 7.752
|
-6.64 Score on a scale
Standard Deviation 6.902
|
SECONDARY outcome
Timeframe: Baseline to weeks 2, 8, 16, 20, & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)
Week 2
|
-16.80 Percentage of change
Standard Deviation 41.680
|
-22.73 Percentage of change
Standard Deviation 32.711
|
-10.30 Percentage of change
Standard Deviation 37.999
|
-22.68 Percentage of change
Standard Deviation 31.305
|
-11.95 Percentage of change
Standard Deviation 47.921
|
—
|
—
|
—
|
—
|
|
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)
Week 8
|
-27.54 Percentage of change
Standard Deviation 59.199
|
-45.85 Percentage of change
Standard Deviation 32.198
|
-13.12 Percentage of change
Standard Deviation 42.775
|
-36.87 Percentage of change
Standard Deviation 36.954
|
-36.14 Percentage of change
Standard Deviation 41.176
|
—
|
—
|
—
|
—
|
|
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)
Week 16
|
-34.02 Percentage of change
Standard Deviation 62.565
|
-48.96 Percentage of change
Standard Deviation 29.801
|
-11.35 Percentage of change
Standard Deviation 51.739
|
-46.69 Percentage of change
Standard Deviation 40.563
|
-41.27 Percentage of change
Standard Deviation 43.616
|
—
|
—
|
—
|
—
|
|
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)
Week 20
|
-35.79 Percentage of change
Standard Deviation 67.398
|
-44.33 Percentage of change
Standard Deviation 36.816
|
-12.08 Percentage of change
Standard Deviation 49.973
|
-47.48 Percentage of change
Standard Deviation 40.616
|
-42.90 Percentage of change
Standard Deviation 46.336
|
—
|
—
|
—
|
—
|
|
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)
Week 24
|
-33.28 Percentage of change
Standard Deviation 72.816
|
-45.63 Percentage of change
Standard Deviation 33.860
|
-11.91 Percentage of change
Standard Deviation 55.694
|
-51.84 Percentage of change
Standard Deviation 41.442
|
-42.36 Percentage of change
Standard Deviation 45.550
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48, & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized Participants at week 24. Only those participants with data available at specified time points are reported.
DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 24
|
-64.74 Percentage of change
Standard Deviation 31.091
|
-44.26 Percentage of change
Standard Deviation 57.217
|
-72.47 Percentage of change
Standard Deviation 27.818
|
-75.53 Percentage of change
Standard Deviation 26.705
|
-61.64 Percentage of change
Standard Deviation 35.809
|
-47.08 Percentage of change
Standard Deviation 82.439
|
-70.77 Percentage of change
Standard Deviation 27.653
|
-55.36 Percentage of change
Standard Deviation 33.443
|
-48.30 Percentage of change
Standard Deviation 57.726
|
|
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 28
|
-71.77 Percentage of change
Standard Deviation 29.970
|
-44.81 Percentage of change
Standard Deviation 56.575
|
-70.02 Percentage of change
Standard Deviation 28.760
|
-72.50 Percentage of change
Standard Deviation 37.184
|
-62.65 Percentage of change
Standard Deviation 43.216
|
-48.86 Percentage of change
Standard Deviation 83.936
|
-65.28 Percentage of change
Standard Deviation 26.807
|
-55.62 Percentage of change
Standard Deviation 34.382
|
-41.13 Percentage of change
Standard Deviation 80.192
|
|
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 32
|
-61.68 Percentage of change
Standard Deviation 42.315
|
-31.65 Percentage of change
Standard Deviation 55.087
|
-77.14 Percentage of change
Standard Deviation 26.277
|
-68.19 Percentage of change
Standard Deviation 38.039
|
-48.69 Percentage of change
Standard Deviation 56.833
|
-50.15 Percentage of change
Standard Deviation 83.141
|
-72.98 Percentage of change
Standard Deviation 17.074
|
-52.99 Percentage of change
Standard Deviation 36.735
|
-41.18 Percentage of change
Standard Deviation 68.097
|
|
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 36
|
-60.50 Percentage of change
Standard Deviation 41.018
|
-35.86 Percentage of change
Standard Deviation 58.071
|
-79.13 Percentage of change
Standard Deviation 24.980
|
-65.76 Percentage of change
Standard Deviation 35.792
|
-48.12 Percentage of change
Standard Deviation 56.610
|
-52.16 Percentage of change
Standard Deviation 84.141
|
-78.26 Percentage of change
Standard Deviation 23.932
|
-49.48 Percentage of change
Standard Deviation 43.137
|
-45.04 Percentage of change
Standard Deviation 65.630
|
|
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 40
|
-58.29 Percentage of change
Standard Deviation 42.112
|
-36.52 Percentage of change
Standard Deviation 58.909
|
-72.31 Percentage of change
Standard Deviation 27.268
|
-69.26 Percentage of change
Standard Deviation 34.172
|
-44.78 Percentage of change
Standard Deviation 59.798
|
-46.41 Percentage of change
Standard Deviation 84.277
|
-83.18 Percentage of change
Standard Deviation 16.284
|
-49.75 Percentage of change
Standard Deviation 42.024
|
-38.69 Percentage of change
Standard Deviation 80.196
|
|
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 44
|
-63.04 Percentage of change
Standard Deviation 42.005
|
-33.25 Percentage of change
Standard Deviation 58.480
|
-76.32 Percentage of change
Standard Deviation 31.166
|
-63.03 Percentage of change
Standard Deviation 41.237
|
-45.33 Percentage of change
Standard Deviation 60.470
|
-39.27 Percentage of change
Standard Deviation 83.804
|
-60.44 Percentage of change
Standard Deviation 28.925
|
-49.15 Percentage of change
Standard Deviation 43.228
|
-48.21 Percentage of change
Standard Deviation 48.871
|
|
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 48
|
-63.97 Percentage of change
Standard Deviation 43.622
|
-35.98 Percentage of change
Standard Deviation 57.915
|
-73.10 Percentage of change
Standard Deviation 28.704
|
-59.02 Percentage of change
Standard Deviation 36.676
|
-45.68 Percentage of change
Standard Deviation 59.933
|
-40.20 Percentage of change
Standard Deviation 84.240
|
-70.04 Percentage of change
Standard Deviation 26.437
|
-50.82 Percentage of change
Standard Deviation 41.018
|
-57.92 Percentage of change
Standard Deviation 45.339
|
|
Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)
Week 52
|
-61.04 Percentage of change
Standard Deviation 42.716
|
-33.21 Percentage of change
Standard Deviation 59.514
|
-72.35 Percentage of change
Standard Deviation 33.768
|
-53.62 Percentage of change
Standard Deviation 36.496
|
-43.64 Percentage of change
Standard Deviation 56.804
|
-35.27 Percentage of change
Standard Deviation 85.953
|
-71.56 Percentage of change
Standard Deviation 28.287
|
-49.24 Percentage of change
Standard Deviation 43.003
|
-57.12 Percentage of change
Standard Deviation 44.899
|
SECONDARY outcome
Timeframe: Baseline to weeks 16, & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
Week 16
|
-6.22 Score on a scale
Standard Deviation 6.272
|
-6.61 Score on a scale
Standard Deviation 5.804
|
-2.50 Score on a scale
Standard Deviation 4.589
|
-6.70 Score on a scale
Standard Deviation 5.813
|
-5.41 Score on a scale
Standard Deviation 6.054
|
—
|
—
|
—
|
—
|
|
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
Week 24
|
-6.70 Score on a scale
Standard Deviation 6.566
|
-6.66 Score on a scale
Standard Deviation 5.868
|
-1.90 Score on a scale
Standard Deviation 5.046
|
-7.35 Score on a scale
Standard Deviation 6.695
|
-5.80 Score on a scale
Standard Deviation 6.187
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 36 & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
Week 24
|
-9.83 Score on a scale
Standard Deviation 6.506
|
-7.44 Score on a scale
Standard Deviation 5.673
|
-9.83 Score on a scale
Standard Deviation 5.132
|
-11.23 Score on a scale
Standard Deviation 6.071
|
-8.64 Score on a scale
Standard Deviation 5.927
|
-8.42 Score on a scale
Standard Deviation 6.386
|
-12.60 Score on a scale
Standard Deviation 6.986
|
-8.29 Score on a scale
Standard Deviation 5.996
|
-6.25 Score on a scale
Standard Deviation 6.083
|
|
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
Week 36
|
-8.20 Score on a scale
Standard Deviation 6.143
|
-7.78 Score on a scale
Standard Deviation 6.123
|
-10.33 Score on a scale
Standard Deviation 5.483
|
-11.46 Score on a scale
Standard Deviation 5.681
|
-8.13 Score on a scale
Standard Deviation 6.463
|
-9.26 Score on a scale
Standard Deviation 6.875
|
-10.71 Score on a scale
Standard Deviation 6.550
|
-8.03 Score on a scale
Standard Deviation 6.385
|
-6.38 Score on a scale
Standard Deviation 6.063
|
|
Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
Week 52
|
-8.82 Score on a scale
Standard Deviation 6.809
|
-7.44 Score on a scale
Standard Deviation 6.594
|
-10.45 Score on a scale
Standard Deviation 5.989
|
-11.31 Score on a scale
Standard Deviation 4.768
|
-8.30 Score on a scale
Standard Deviation 5.706
|
-6.48 Score on a scale
Standard Deviation 6.539
|
-9.71 Score on a scale
Standard Deviation 4.751
|
-8.34 Score on a scale
Standard Deviation 6.893
|
-7.14 Score on a scale
Standard Deviation 6.125
|
SECONDARY outcome
Timeframe: Baseline to weeks 16, & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
Week 16
|
-36.42 Percentage of change
Standard Deviation 37.103
|
-38.72 Percentage of change
Standard Deviation 30.762
|
-17.04 Percentage of change
Standard Deviation 32.553
|
-40.56 Percentage of change
Standard Deviation 37.340
|
-33.42 Percentage of change
Standard Deviation 34.745
|
—
|
—
|
—
|
—
|
|
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)
Week 24
|
-40.45 Percentage of change
Standard Deviation 40.708
|
-39.35 Percentage of change
Standard Deviation 31.799
|
-12.31 Percentage of change
Standard Deviation 37.504
|
-45.18 Percentage of change
Standard Deviation 42.438
|
-36.20 Percentage of change
Standard Deviation 41.363
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 36 & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified time points are reported.
ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
Week 24
|
-56.01 Percentage of change
Standard Deviation 36.112
|
-49.97 Percentage of change
Standard Deviation 34.078
|
-65.46 Percentage of change
Standard Deviation 26.823
|
-66.75 Percentage of change
Standard Deviation 32.632
|
-57.08 Percentage of change
Standard Deviation 37.656
|
-53.10 Percentage of change
Standard Deviation 40.207
|
-63.92 Percentage of change
Standard Deviation 29.784
|
-50.66 Percentage of change
Standard Deviation 33.458
|
-44.95 Percentage of change
Standard Deviation 45.331
|
|
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
Week 36
|
-50.01 Percentage of change
Standard Deviation 37.199
|
-50.87 Percentage of change
Standard Deviation 33.197
|
-69.73 Percentage of change
Standard Deviation 28.925
|
-69.01 Percentage of change
Standard Deviation 29.493
|
-50.38 Percentage of change
Standard Deviation 42.649
|
-58.44 Percentage of change
Standard Deviation 43.340
|
-62.63 Percentage of change
Standard Deviation 23.130
|
-48.59 Percentage of change
Standard Deviation 38.274
|
-49.42 Percentage of change
Standard Deviation 45.902
|
|
Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)
Week 52
|
-52.75 Percentage of change
Standard Deviation 41.167
|
-47.15 Percentage of change
Standard Deviation 39.681
|
-67.84 Percentage of change
Standard Deviation 32.469
|
-69.93 Percentage of change
Standard Deviation 26.250
|
-54.77 Percentage of change
Standard Deviation 34.128
|
-41.39 Percentage of change
Standard Deviation 43.875
|
-64.19 Percentage of change
Standard Deviation 28.274
|
-50.29 Percentage of change
Standard Deviation 41.341
|
-53.35 Percentage of change
Standard Deviation 47.196
|
SECONDARY outcome
Timeframe: Baseline to weeks 8 16, 20, & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
Week 8
|
-2.35 Score on a scale
Standard Deviation 5.641
|
-3.29 Score on a scale
Standard Deviation 5.132
|
-0.97 Score on a scale
Standard Deviation 3.940
|
-2.20 Score on a scale
Standard Deviation 4.639
|
-2.07 Score on a scale
Standard Deviation 6.194
|
—
|
—
|
—
|
—
|
|
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
Week 16
|
-3.04 Score on a scale
Standard Deviation 6.292
|
-3.74 Score on a scale
Standard Deviation 6.401
|
-0.57 Score on a scale
Standard Deviation 5.088
|
-2.67 Score on a scale
Standard Deviation 5.761
|
-2.53 Score on a scale
Standard Deviation 6.510
|
—
|
—
|
—
|
—
|
|
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
Week 20
|
-3.38 Score on a scale
Standard Deviation 6.787
|
-4.24 Score on a scale
Standard Deviation 5.873
|
-0.66 Score on a scale
Standard Deviation 4.176
|
-2.52 Score on a scale
Standard Deviation 7.254
|
-2.35 Score on a scale
Standard Deviation 7.326
|
—
|
—
|
—
|
—
|
|
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
Week 24
|
-2.83 Score on a scale
Standard Deviation 6.818
|
-4.00 Score on a scale
Standard Deviation 6.802
|
-0.97 Score on a scale
Standard Deviation 4.196
|
-2.96 Score on a scale
Standard Deviation 7.550
|
-2.30 Score on a scale
Standard Deviation 6.880
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 24
|
-5.58 score on a scale
Standard Deviation 10.184
|
-2.81 score on a scale
Standard Deviation 6.822
|
-3.67 score on a scale
Standard Deviation 6.998
|
-4.54 score on a scale
Standard Deviation 8.482
|
-1.73 score on a scale
Standard Deviation 7.434
|
-4.42 score on a scale
Standard Deviation 7.890
|
-8.20 score on a scale
Standard Deviation 6.340
|
-4.03 score on a scale
Standard Deviation 6.710
|
-0.38 score on a scale
Standard Deviation 4.660
|
|
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 28
|
-6.50 score on a scale
Standard Deviation 11.430
|
-2.70 score on a scale
Standard Deviation 6.916
|
-4.33 score on a scale
Standard Deviation 7.679
|
-3.54 score on a scale
Standard Deviation 7.965
|
-2.52 score on a scale
Standard Deviation 6.205
|
-4.97 score on a scale
Standard Deviation 8.428
|
-7.29 score on a scale
Standard Deviation 5.251
|
-5.26 score on a scale
Standard Deviation 7.034
|
0.38 score on a scale
Standard Deviation 4.753
|
|
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 32
|
-4.09 score on a scale
Standard Deviation 9.027
|
-2.74 score on a scale
Standard Deviation 7.593
|
-4.42 score on a scale
Standard Deviation 7.242
|
-3.38 score on a scale
Standard Deviation 8.893
|
-1.24 score on a scale
Standard Deviation 6.996
|
-5.66 score on a scale
Standard Deviation 8.280
|
-6.86 score on a scale
Standard Deviation 5.460
|
-3.97 score on a scale
Standard Deviation 6.483
|
-0.20 score on a scale
Standard Deviation 4.491
|
|
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 36
|
-3.80 score on a scale
Standard Deviation 10.497
|
-2.52 score on a scale
Standard Deviation 5.833
|
-4.42 score on a scale
Standard Deviation 6.999
|
-1.85 score on a scale
Standard Deviation 9.754
|
-1.22 score on a scale
Standard Deviation 8.015
|
-5.50 score on a scale
Standard Deviation 8.828
|
-7.14 score on a scale
Standard Deviation 4.880
|
-3.75 score on a scale
Standard Deviation 7.878
|
0.29 score on a scale
Standard Deviation 4.250
|
|
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 40
|
-3.09 score on a scale
Standard Deviation 10.222
|
-2.70 score on a scale
Standard Deviation 6.151
|
-3.55 score on a scale
Standard Deviation 7.594
|
-2.92 score on a scale
Standard Deviation 8.864
|
-1.40 score on a scale
Standard Deviation 6.966
|
-5.16 score on a scale
Standard Deviation 8.674
|
-7.43 score on a scale
Standard Deviation 5.563
|
-3.29 score on a scale
Standard Deviation 5.593
|
0.50 score on a scale
Standard Deviation 5.125
|
|
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 44
|
-3.45 score on a scale
Standard Deviation 10.511
|
-3.07 score on a scale
Standard Deviation 5.313
|
-4.25 score on a scale
Standard Deviation 7.225
|
-2.69 score on a scale
Standard Deviation 8.873
|
-0.29 score on a scale
Standard Deviation 6.963
|
-4.56 score on a scale
Standard Deviation 8.879
|
-5.43 score on a scale
Standard Deviation 5.192
|
-3.71 score on a scale
Standard Deviation 7.408
|
-0.21 score on a scale
Standard Deviation 4.318
|
|
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 48
|
-4.40 score on a scale
Standard Deviation 10.024
|
-2.85 score on a scale
Standard Deviation 5.559
|
-3.33 score on a scale
Standard Deviation 7.797
|
-3.08 score on a scale
Standard Deviation 8.883
|
-0.68 score on a scale
Standard Deviation 7.078
|
-5.23 score on a scale
Standard Deviation 8.724
|
-7.43 score on a scale
Standard Deviation 5.412
|
-4.17 score on a scale
Standard Deviation 7.269
|
-1.00 score on a scale
Standard Deviation 4.852
|
|
Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 52
|
-2.55 score on a scale
Standard Deviation 8.359
|
-3.00 score on a scale
Standard Deviation 5.877
|
-4.18 score on a scale
Standard Deviation 7.167
|
-2.46 score on a scale
Standard Deviation 9.162
|
-0.80 score on a scale
Standard Deviation 7.092
|
-4.59 score on a scale
Standard Deviation 8.454
|
-7.29 score on a scale
Standard Deviation 5.794
|
-3.13 score on a scale
Standard Deviation 8.082
|
-0.64 score on a scale
Standard Deviation 5.719
|
SECONDARY outcome
Timeframe: Baseline to weeks 8, 16, 20, & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
Week 20
|
-17.62 Percentage of change
Standard Deviation 59.518
|
-25.97 Percentage of change
Standard Deviation 83.249
|
-5.02 Percentage of change
Standard Deviation 78.180
|
-20.15 Percentage of change
Standard Deviation 65.506
|
-7.39 Percentage of change
Standard Deviation 62.693
|
—
|
—
|
—
|
—
|
|
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
Week 24
|
-17.75 Percentage of change
Standard Deviation 52.049
|
-12.07 Percentage of change
Standard Deviation 120.061
|
-8.17 Percentage of change
Standard Deviation 77.872
|
-13.22 Percentage of change
Standard Deviation 97.953
|
-8.67 Percentage of change
Standard Deviation 60.563
|
—
|
—
|
—
|
—
|
|
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
Week 8
|
-10.22 Percentage of change
Standard Deviation 56.395
|
-13.15 Percentage of change
Standard Deviation 69.427
|
-0.66 Percentage of change
Standard Deviation 77.969
|
-18.40 Percentage of change
Standard Deviation 46.151
|
-11.76 Percentage of change
Standard Deviation 48.829
|
—
|
—
|
—
|
—
|
|
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)
Week 16
|
-15.84 Percentage of change
Standard Deviation 54.001
|
-17.47 Percentage of change
Standard Deviation 94.346
|
2.82 Percentage of change
Standard Deviation 101.930
|
-18.12 Percentage of change
Standard Deviation 56.175
|
-11.72 Percentage of change
Standard Deviation 54.678
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 28, 32, 36, 40, 44, 48 & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.
The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 28
|
-30.97 Percentage of change
Standard Deviation 51.945
|
-17.92 Percentage of change
Standard Deviation 53.098
|
4.22 Percentage of change
Standard Deviation 96.782
|
-18.57 Percentage of change
Standard Deviation 53.870
|
-22.56 Percentage of change
Standard Deviation 67.645
|
-30.52 Percentage of change
Standard Deviation 66.305
|
-49.58 Percentage of change
Standard Deviation 31.509
|
-33.17 Percentage of change
Standard Deviation 41.412
|
-38.39 Percentage of change
Standard Deviation 77.030
|
|
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 24
|
-34.27 Percentage of change
Standard Deviation 48.841
|
-13.63 Percentage of change
Standard Deviation 65.697
|
-20.28 Percentage of change
Standard Deviation 49.825
|
-28.01 Percentage of change
Standard Deviation 54.369
|
-17.89 Percentage of change
Standard Deviation 76.693
|
-32.24 Percentage of change
Standard Deviation 65.070
|
-46.94 Percentage of change
Standard Deviation 22.063
|
-22.38 Percentage of change
Standard Deviation 58.898
|
-32.55 Percentage of change
Standard Deviation 66.184
|
|
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 32
|
-29.10 Percentage of change
Standard Deviation 52.035
|
-20.31 Percentage of change
Standard Deviation 63.189
|
-11.36 Percentage of change
Standard Deviation 87.084
|
-19.06 Percentage of change
Standard Deviation 60.844
|
-14.02 Percentage of change
Standard Deviation 82.893
|
-43.96 Percentage of change
Standard Deviation 68.306
|
-42.56 Percentage of change
Standard Deviation 27.759
|
-32.62 Percentage of change
Standard Deviation 49.764
|
-38.06 Percentage of change
Standard Deviation 69.176
|
|
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 36
|
-6.28 Percentage of change
Standard Deviation 62.772
|
-22.30 Percentage of change
Standard Deviation 51.020
|
-8.75 Percentage of change
Standard Deviation 85.214
|
11.76 Percentage of change
Standard Deviation 84.979
|
-9.44 Percentage of change
Standard Deviation 81.662
|
-37.19 Percentage of change
Standard Deviation 71.372
|
-51.27 Percentage of change
Standard Deviation 29.960
|
-32.59 Percentage of change
Standard Deviation 49.531
|
-9.11 Percentage of change
Standard Deviation 110.289
|
|
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 40
|
7.25 Percentage of change
Standard Deviation 82.513
|
-21.32 Percentage of change
Standard Deviation 50.659
|
4.24 Percentage of change
Standard Deviation 91.941
|
-13.29 Percentage of change
Standard Deviation 60.249
|
-18.23 Percentage of change
Standard Deviation 79.025
|
-40.11 Percentage of change
Standard Deviation 67.991
|
-56.66 Percentage of change
Standard Deviation 33.879
|
-35.92 Percentage of change
Standard Deviation 46.888
|
-1.02 Percentage of change
Standard Deviation 98.096
|
|
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 44
|
-23.23 Percentage of change
Standard Deviation 56.824
|
-31.88 Percentage of change
Standard Deviation 49.100
|
-15.90 Percentage of change
Standard Deviation 85.382
|
-2.42 Percentage of change
Standard Deviation 54.527
|
-5.30 Percentage of change
Standard Deviation 88.418
|
-30.93 Percentage of change
Standard Deviation 71.891
|
-41.44 Percentage of change
Standard Deviation 37.143
|
-32.73 Percentage of change
Standard Deviation 57.357
|
-22.21 Percentage of change
Standard Deviation 80.062
|
|
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 48
|
-28.27 Percentage of change
Standard Deviation 51.499
|
-21.89 Percentage of change
Standard Deviation 53.010
|
4.97 Percentage of change
Standard Deviation 88.017
|
-14.15 Percentage of change
Standard Deviation 60.660
|
-4.47 Percentage of change
Standard Deviation 95.509
|
-39.36 Percentage of change
Standard Deviation 69.672
|
-60.77 Percentage of change
Standard Deviation 35.190
|
-36.32 Percentage of change
Standard Deviation 47.746
|
-34.95 Percentage of change
Standard Deviation 67.833
|
|
Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)
Week 52
|
-13.70 Percentage of change
Standard Deviation 44.085
|
-19.98 Percentage of change
Standard Deviation 56.405
|
0.43 Percentage of change
Standard Deviation 85.522
|
-8.10 Percentage of change
Standard Deviation 67.182
|
-7.59 Percentage of change
Standard Deviation 92.868
|
-14.22 Percentage of change
Standard Deviation 78.739
|
-59.23 Percentage of change
Standard Deviation 37.434
|
-23.84 Percentage of change
Standard Deviation 50.933
|
-18.16 Percentage of change
Standard Deviation 69.310
|
SECONDARY outcome
Timeframe: Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 15
|
-2.10 score on a scale
Standard Deviation 2.290
|
-2.32 score on a scale
Standard Deviation 2.288
|
-0.57 score on a scale
Standard Deviation 2.018
|
-1.87 score on a scale
Standard Deviation 2.386
|
-2.08 score on a scale
Standard Deviation 2.511
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 1
|
-0.49 score on a scale
Standard Deviation 0.965
|
-0.45 score on a scale
Standard Deviation 0.908
|
-0.28 score on a scale
Standard Deviation 1.071
|
-0.54 score on a scale
Standard Deviation 1.096
|
-0.56 score on a scale
Standard Deviation 0.978
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 2
|
-0.73 score on a scale
Standard Deviation 1.075
|
-0.81 score on a scale
Standard Deviation 1.224
|
-0.42 score on a scale
Standard Deviation 1.046
|
-0.65 score on a scale
Standard Deviation 1.316
|
-0.79 score on a scale
Standard Deviation 1.367
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 3
|
-1.05 score on a scale
Standard Deviation 1.302
|
-0.88 score on a scale
Standard Deviation 1.478
|
-0.65 score on a scale
Standard Deviation 1.567
|
-0.90 score on a scale
Standard Deviation 1.619
|
-0.92 score on a scale
Standard Deviation 1.392
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 4
|
-1.36 score on a scale
Standard Deviation 1.443
|
-1.09 score on a scale
Standard Deviation 1.668
|
-0.77 score on a scale
Standard Deviation 1.744
|
-.096 score on a scale
Standard Deviation 1.672
|
-1.25 score on a scale
Standard Deviation 1.657
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 5
|
-1.42 score on a scale
Standard Deviation 1.591
|
-1.49 score on a scale
Standard Deviation 1.799
|
-0.83 score on a scale
Standard Deviation 2.030
|
-0.99 score on a scale
Standard Deviation 1.811
|
-1.38 score on a scale
Standard Deviation 1.653
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 6
|
-1.38 score on a scale
Standard Deviation 1.666
|
-1.58 score on a scale
Standard Deviation 2.057
|
-0.94 score on a scale
Standard Deviation 1.899
|
-1.09 score on a scale
Standard Deviation 1.679
|
-1.35 score on a scale
Standard Deviation 1.818
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 7
|
-1.57 score on a scale
Standard Deviation 1.710
|
-1.78 score on a scale
Standard Deviation 2.002
|
-0.78 score on a scale
Standard Deviation 1.922
|
-1.25 score on a scale
Standard Deviation 1.966
|
-1.54 score on a scale
Standard Deviation 1.850
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 8
|
-1.60 score on a scale
Standard Deviation 1.816
|
-1.93 score on a scale
Standard Deviation 2.053
|
-0.80 score on a scale
Standard Deviation 1.979
|
-1.42 score on a scale
Standard Deviation 2.062
|
-1.50 score on a scale
Standard Deviation 1.786
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 9
|
-1.89 score on a scale
Standard Deviation 1.885
|
-2.13 score on a scale
Standard Deviation 2.031
|
-1.00 score on a scale
Standard Deviation 2.142
|
-1.44 score on a scale
Standard Deviation 2.104
|
-1.52 score on a scale
Standard Deviation 1.805
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 10
|
-1.82 score on a scale
Standard Deviation 2.082
|
-2.17 score on a scale
Standard Deviation 2.137
|
-0.97 score on a scale
Standard Deviation 2.244
|
-1.62 score on a scale
Standard Deviation 2.162
|
-1.67 score on a scale
Standard Deviation 1.852
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 11
|
-2.06 score on a scale
Standard Deviation 2.091
|
-2.31 score on a scale
Standard Deviation 2.248
|
-0.93 score on a scale
Standard Deviation 2.111
|
-1.68 score on a scale
Standard Deviation 2.176
|
-1.67 score on a scale
Standard Deviation 1.936
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 12
|
-1.96 score on a scale
Standard Deviation 2.107
|
-2.28 score on a scale
Standard Deviation 2.262
|
-0.79 score on a scale
Standard Deviation 2.162
|
-1.70 score on a scale
Standard Deviation 2.204
|
-1.65 score on a scale
Standard Deviation 2.074
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 13
|
-2.05 score on a scale
Standard Deviation 2.164
|
-2.28 score on a scale
Standard Deviation 2.291
|
-0.72 score on a scale
Standard Deviation 2.087
|
-1.83 score on a scale
Standard Deviation 2.295
|
-1.87 score on a scale
Standard Deviation 2.247
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 14
|
-2.13 score on a scale
Standard Deviation 2.308
|
-2.35 score on a scale
Standard Deviation 2.316
|
-0.58 score on a scale
Standard Deviation 2.055
|
-1.82 score on a scale
Standard Deviation 2.355
|
-2.02 score on a scale
Standard Deviation 2.468
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 16
|
-2.22 score on a scale
Standard Deviation 2.275
|
-2.31 score on a scale
Standard Deviation 2.301
|
-0.54 score on a scale
Standard Deviation 2.077
|
-2.06 score on a scale
Standard Deviation 2.539
|
-2.09 score on a scale
Standard Deviation 2.497
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 17
|
-2.14 score on a scale
Standard Deviation 2.368
|
-2.35 score on a scale
Standard Deviation 2.346
|
-0.61 score on a scale
Standard Deviation 2.143
|
-2.13 score on a scale
Standard Deviation 2.465
|
-2.18 score on a scale
Standard Deviation 2.457
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 18
|
-2.16 score on a scale
Standard Deviation 2.307
|
-2.37 score on a scale
Standard Deviation 2.383
|
-0.55 score on a scale
Standard Deviation 2.168
|
-2.18 score on a scale
Standard Deviation 2.534
|
-2.21 score on a scale
Standard Deviation 2.543
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 19
|
-2.14 score on a scale
Standard Deviation 2.291
|
-2.38 score on a scale
Standard Deviation 2.463
|
-0.75 score on a scale
Standard Deviation 2.278
|
-2.19 score on a scale
Standard Deviation 2.484
|
-2.22 score on a scale
Standard Deviation 2.563
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 20
|
-2.13 score on a scale
Standard Deviation 2.360
|
-2.31 score on a scale
Standard Deviation 2.401
|
-0.67 score on a scale
Standard Deviation 2.201
|
-2.28 score on a scale
Standard Deviation 2.522
|
-2.19 score on a scale
Standard Deviation 2.530
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 21
|
-2.27 score on a scale
Standard Deviation 2.352
|
-2.43 score on a scale
Standard Deviation 2.404
|
-0.76 score on a scale
Standard Deviation 2.332
|
-2.28 score on a scale
Standard Deviation 2.516
|
-2.23 score on a scale
Standard Deviation 2.576
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 22
|
-2.25 score on a scale
Standard Deviation 2.438
|
-2.44 score on a scale
Standard Deviation 2.383
|
-0.73 score on a scale
Standard Deviation 2.314
|
-2.38 score on a scale
Standard Deviation 2.622
|
-2.29 score on a scale
Standard Deviation 2.699
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 23
|
-2.20 score on a scale
Standard Deviation 2.529
|
-2.59 score on a scale
Standard Deviation 2.453
|
-0.61 score on a scale
Standard Deviation 2.215
|
-2.56 score on a scale
Standard Deviation 2.671
|
-2.27 score on a scale
Standard Deviation 2.538
|
—
|
—
|
—
|
—
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 24
|
-2.21 score on a scale
Standard Deviation 2.616
|
-2.46 score on a scale
Standard Deviation 2.427
|
-0.55 score on a scale
Standard Deviation 2.224
|
-2.58 score on a scale
Standard Deviation 2.662
|
-2.30 score on a scale
Standard Deviation 2.672
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified timepoints are reported.
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 33
|
-3.06 Score on a scale
Standard Deviation 2.755
|
-1.85 Score on a scale
Standard Deviation 2.867
|
-4.32 Score on a scale
Standard Deviation 2.316
|
-3.60 Score on a scale
Standard Deviation 2.722
|
-2.49 Score on a scale
Standard Deviation 3.220
|
-2.83 Score on a scale
Standard Deviation 2.579
|
-4.14 Score on a scale
Standard Deviation 1.843
|
-2.66 Score on a scale
Standard Deviation 2.705
|
-1.45 Score on a scale
Standard Deviation 3.332
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 24
|
-4.00 Score on a scale
Standard Deviation 2.711
|
-2.25 Score on a scale
Standard Deviation 2.861
|
-4.34 Score on a scale
Standard Deviation 2.169
|
-3.63 Score on a scale
Standard Deviation 2.380
|
-2.83 Score on a scale
Standard Deviation 2.909
|
-2.92 Score on a scale
Standard Deviation 2.539
|
-4.63 Score on a scale
Standard Deviation 1.822
|
-2.82 Score on a scale
Standard Deviation 2.571
|
-1.95 Score on a scale
Standard Deviation 3.083
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 25
|
-4.08 Score on a scale
Standard Deviation 2.726
|
-2.42 Score on a scale
Standard Deviation 2.895
|
-4.12 Score on a scale
Standard Deviation 2.413
|
-3.83 Score on a scale
Standard Deviation 2.353
|
-2.73 Score on a scale
Standard Deviation 2.973
|
-2.81 Score on a scale
Standard Deviation 2.405
|
-4.92 Score on a scale
Standard Deviation 1.863
|
-2.64 Score on a scale
Standard Deviation 2.577
|
-2.08 Score on a scale
Standard Deviation 3.177
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 26
|
-3.75 Score on a scale
Standard Deviation 2.654
|
-2.33 Score on a scale
Standard Deviation 3.096
|
-3.83 Score on a scale
Standard Deviation 2.428
|
-3.82 Score on a scale
Standard Deviation 2.442
|
-2.71 Score on a scale
Standard Deviation 2.891
|
-2.56 Score on a scale
Standard Deviation 2.400
|
-4.56 Score on a scale
Standard Deviation 1.903
|
-2.70 Score on a scale
Standard Deviation 2.634
|
-1.93 Score on a scale
Standard Deviation 3.202
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 27
|
-3.65 Score on a scale
Standard Deviation 2.619
|
-2.28 Score on a scale
Standard Deviation 2.994
|
-4.09 Score on a scale
Standard Deviation 2.567
|
-3.84 Score on a scale
Standard Deviation 2.444
|
-2.58 Score on a scale
Standard Deviation 2.819
|
-2.84 Score on a scale
Standard Deviation 2.467
|
-4.51 Score on a scale
Standard Deviation 1.790
|
-2.57 Score on a scale
Standard Deviation 2.748
|
-2.04 Score on a scale
Standard Deviation 3.351
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 34
|
-3.32 Score on a scale
Standard Deviation 2.732
|
-1.30 Score on a scale
Standard Deviation 2.792
|
-4.43 Score on a scale
Standard Deviation 2.297
|
-3.49 Score on a scale
Standard Deviation 2.644
|
-2.26 Score on a scale
Standard Deviation 3.114
|
-2.84 Score on a scale
Standard Deviation 2.508
|
-3.97 Score on a scale
Standard Deviation 1.948
|
-2.58 Score on a scale
Standard Deviation 2.665
|
-1.86 Score on a scale
Standard Deviation 3.578
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 28
|
-3.59 Score on a scale
Standard Deviation 2.575
|
-2.29 Score on a scale
Standard Deviation 2.782
|
-4.02 Score on a scale
Standard Deviation 2.525
|
-3.86 Score on a scale
Standard Deviation 2.432
|
-2.56 Score on a scale
Standard Deviation 2.892
|
-3.01 Score on a scale
Standard Deviation 2.504
|
-4.38 Score on a scale
Standard Deviation 1.827
|
-2.75 Score on a scale
Standard Deviation 2.753
|
-1.89 Score on a scale
Standard Deviation 3.459
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 29
|
-3.81 Score on a scale
Standard Deviation 2.425
|
-1.85 Score on a scale
Standard Deviation 2.733
|
-4.16 Score on a scale
Standard Deviation 2.387
|
-3.73 Score on a scale
Standard Deviation 2.612
|
-2.51 Score on a scale
Standard Deviation 2.874
|
-2.99 Score on a scale
Standard Deviation 2.591
|
-4.50 Score on a scale
Standard Deviation 2.035
|
-2.64 Score on a scale
Standard Deviation 2.695
|
-1.81 Score on a scale
Standard Deviation 3.386
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 30
|
-3.76 Score on a scale
Standard Deviation 2.394
|
-2.07 Score on a scale
Standard Deviation 2.564
|
-4.44 Score on a scale
Standard Deviation 2.526
|
-3.32 Score on a scale
Standard Deviation 2.564
|
-2.78 Score on a scale
Standard Deviation 3.030
|
-2.68 Score on a scale
Standard Deviation 2.490
|
-3.73 Score on a scale
Standard Deviation 2.125
|
-2.59 Score on a scale
Standard Deviation 2.653
|
-1.80 Score on a scale
Standard Deviation 3.445
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 31
|
-3.73 Score on a scale
Standard Deviation 2.431
|
-1.71 Score on a scale
Standard Deviation 2.980
|
-4.18 Score on a scale
Standard Deviation 2.428
|
-3.41 Score on a scale
Standard Deviation 2.580
|
-2.74 Score on a scale
Standard Deviation 3.213
|
-2.81 Score on a scale
Standard Deviation 2.662
|
-4.02 Score on a scale
Standard Deviation 2.280
|
-2.78 Score on a scale
Standard Deviation 2.691
|
-1.46 Score on a scale
Standard Deviation 3.132
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 32
|
-3.13 Score on a scale
Standard Deviation 2.818
|
-1.51 Score on a scale
Standard Deviation 2.736
|
-4.27 Score on a scale
Standard Deviation 2.261
|
-3.43 Score on a scale
Standard Deviation 2.607
|
-2.56 Score on a scale
Standard Deviation 3.098
|
-2.86 Score on a scale
Standard Deviation 2.617
|
-4.40 Score on a scale
Standard Deviation 2.170
|
-2.68 Score on a scale
Standard Deviation 2.674
|
-1.54 Score on a scale
Standard Deviation 3.221
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 35
|
-3.09 Score on a scale
Standard Deviation 2.600
|
-1.42 Score on a scale
Standard Deviation 2.685
|
-4.60 Score on a scale
Standard Deviation 2.497
|
-3.47 Score on a scale
Standard Deviation 2.712
|
-2.51 Score on a scale
Standard Deviation 3.219
|
-3.01 Score on a scale
Standard Deviation 2.529
|
-4.55 Score on a scale
Standard Deviation 2.055
|
-2.65 Score on a scale
Standard Deviation 2.674
|
-1.86 Score on a scale
Standard Deviation 3.390
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 36
|
-2.81 Score on a scale
Standard Deviation 2.693
|
-1.64 Score on a scale
Standard Deviation 2.670
|
-4.67 Score on a scale
Standard Deviation 2.468
|
-3.48 Score on a scale
Standard Deviation 2.752
|
-2.47 Score on a scale
Standard Deviation 3.262
|
-2.90 Score on a scale
Standard Deviation 2.527
|
-4.14 Score on a scale
Standard Deviation 1.845
|
-2.39 Score on a scale
Standard Deviation 2.626
|
-1.56 Score on a scale
Standard Deviation 3.318
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 37
|
-2.50 Score on a scale
Standard Deviation 2.523
|
-1.85 Score on a scale
Standard Deviation 2.758
|
-4.51 Score on a scale
Standard Deviation 2.429
|
-3.44 Score on a scale
Standard Deviation 2.726
|
-2.53 Score on a scale
Standard Deviation 3.244
|
-3.11 Score on a scale
Standard Deviation 2.508
|
-4.49 Score on a scale
Standard Deviation 1.992
|
-2.33 Score on a scale
Standard Deviation 2.564
|
-1.58 Score on a scale
Standard Deviation 3.328
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 38
|
-2.06 Score on a scale
Standard Deviation 2.464
|
-1.74 Score on a scale
Standard Deviation 2.803
|
-4.57 Score on a scale
Standard Deviation 2.505
|
-3.31 Score on a scale
Standard Deviation 3.182
|
-2.33 Score on a scale
Standard Deviation 3.159
|
-3.16 Score on a scale
Standard Deviation 2.672
|
-4.52 Score on a scale
Standard Deviation 2.046
|
-2.37 Score on a scale
Standard Deviation 2.548
|
-1.64 Score on a scale
Standard Deviation 3.449
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 39
|
-2.52 Score on a scale
Standard Deviation 2.462
|
-1.81 Score on a scale
Standard Deviation 2.792
|
-4.24 Score on a scale
Standard Deviation 2.451
|
-3.34 Score on a scale
Standard Deviation 3.206
|
-2.35 Score on a scale
Standard Deviation 3.212
|
-3.07 Score on a scale
Standard Deviation 2.548
|
-4.66 Score on a scale
Standard Deviation 2.070
|
-2.27 Score on a scale
Standard Deviation 2.605
|
-1.78 Score on a scale
Standard Deviation 3.350
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 40
|
-2.11 Score on a scale
Standard Deviation 2.064
|
-1.74 Score on a scale
Standard Deviation 2.697
|
-4.24 Score on a scale
Standard Deviation 2.419
|
-3.29 Score on a scale
Standard Deviation 3.245
|
-2.26 Score on a scale
Standard Deviation 3.208
|
-2.92 Score on a scale
Standard Deviation 2.574
|
-2.98 Score on a scale
Standard Deviation 1.946
|
-2.38 Score on a scale
Standard Deviation 2.659
|
-1.67 Score on a scale
Standard Deviation 3.413
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 41
|
-1.82 Score on a scale
Standard Deviation 1.991
|
-1.97 Score on a scale
Standard Deviation 2.774
|
-4.56 Score on a scale
Standard Deviation 2.344
|
-3.25 Score on a scale
Standard Deviation 3.188
|
-2.26 Score on a scale
Standard Deviation 3.213
|
-2.67 Score on a scale
Standard Deviation 2.798
|
-3.73 Score on a scale
Standard Deviation 2.142
|
-2.41 Score on a scale
Standard Deviation 2.697
|
-1.64 Score on a scale
Standard Deviation 3.856
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 42
|
-2.53 Score on a scale
Standard Deviation 2.603
|
-1.91 Score on a scale
Standard Deviation 2.835
|
-4.67 Score on a scale
Standard Deviation 2.494
|
-3.21 Score on a scale
Standard Deviation 3.218
|
-2.28 Score on a scale
Standard Deviation 3.307
|
-2.92 Score on a scale
Standard Deviation 2.876
|
-3.78 Score on a scale
Standard Deviation 2.183
|
-2.24 Score on a scale
Standard Deviation 2.655
|
-2.01 Score on a scale
Standard Deviation 3.719
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 43
|
-2.53 Score on a scale
Standard Deviation 2.523
|
-1.74 Score on a scale
Standard Deviation 2.821
|
-4.64 Score on a scale
Standard Deviation 2.864
|
-3.30 Score on a scale
Standard Deviation 3.246
|
-2.27 Score on a scale
Standard Deviation 3.158
|
-2.82 Score on a scale
Standard Deviation 2.612
|
-3.70 Score on a scale
Standard Deviation 2.063
|
-2.22 Score on a scale
Standard Deviation 2.736
|
-2.31 Score on a scale
Standard Deviation 3.823
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 44
|
-2.37 Score on a scale
Standard Deviation 2.349
|
-1.79 Score on a scale
Standard Deviation 2.690
|
-4.83 Score on a scale
Standard Deviation 2.484
|
-3.34 Score on a scale
Standard Deviation 3.276
|
-2.31 Score on a scale
Standard Deviation 3.196
|
-2.81 Score on a scale
Standard Deviation 2.693
|
-3.51 Score on a scale
Standard Deviation 2.084
|
-2.21 Score on a scale
Standard Deviation 2.656
|
-2.01 Score on a scale
Standard Deviation 3.730
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 45
|
-1.97 Score on a scale
Standard Deviation 2.110
|
-1.87 Score on a scale
Standard Deviation 2.745
|
-4.68 Score on a scale
Standard Deviation 2.637
|
-3.63 Score on a scale
Standard Deviation 3.034
|
-2.41 Score on a scale
Standard Deviation 3.267
|
-2.62 Score on a scale
Standard Deviation 2.636
|
-3.58 Score on a scale
Standard Deviation 1.992
|
-2.23 Score on a scale
Standard Deviation 2.678
|
-1.87 Score on a scale
Standard Deviation 3.752
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 46
|
-2.61 Score on a scale
Standard Deviation 2.550
|
-1.84 Score on a scale
Standard Deviation 2.679
|
-4.41 Score on a scale
Standard Deviation 2.864
|
-3.29 Score on a scale
Standard Deviation 3.359
|
-2.46 Score on a scale
Standard Deviation 3.219
|
-2.33 Score on a scale
Standard Deviation 2.614
|
-3.78 Score on a scale
Standard Deviation 2.146
|
-2.28 Score on a scale
Standard Deviation 2.713
|
-1.99 Score on a scale
Standard Deviation 4.071
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 47
|
-1.95 Score on a scale
Standard Deviation 2.320
|
-1.84 Score on a scale
Standard Deviation 2.796
|
-4.46 Score on a scale
Standard Deviation 2.830
|
-3.17 Score on a scale
Standard Deviation 3.283
|
-2.31 Score on a scale
Standard Deviation 3.183
|
-2.30 Score on a scale
Standard Deviation 2.731
|
-3.66 Score on a scale
Standard Deviation 2.139
|
-2.38 Score on a scale
Standard Deviation 2.645
|
-1.78 Score on a scale
Standard Deviation 3.762
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 48
|
-2.36 Score on a scale
Standard Deviation 2.366
|
-1.84 Score on a scale
Standard Deviation 2.761
|
-4.64 Score on a scale
Standard Deviation 2.892
|
-2.82 Score on a scale
Standard Deviation 3.247
|
-2.43 Score on a scale
Standard Deviation 3.202
|
-2.04 Score on a scale
Standard Deviation 2.636
|
-3.96 Score on a scale
Standard Deviation 2.251
|
-2.31 Score on a scale
Standard Deviation 2.731
|
-2.05 Score on a scale
Standard Deviation 3.716
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 49
|
-2.66 Score on a scale
Standard Deviation 2.610
|
-2.02 Score on a scale
Standard Deviation 2.909
|
-4.68 Score on a scale
Standard Deviation 2.893
|
-2.80 Score on a scale
Standard Deviation 3.230
|
-2.27 Score on a scale
Standard Deviation 3.139
|
-2.02 Score on a scale
Standard Deviation 2.625
|
-3.65 Score on a scale
Standard Deviation 1.938
|
-2.46 Score on a scale
Standard Deviation 2.847
|
-2.06 Score on a scale
Standard Deviation 3.875
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 50
|
-2.44 Score on a scale
Standard Deviation 2.699
|
-1.90 Score on a scale
Standard Deviation 2.913
|
-4.56 Score on a scale
Standard Deviation 2.923
|
-2.78 Score on a scale
Standard Deviation 3.223
|
-2.23 Score on a scale
Standard Deviation 3.218
|
-1.87 Score on a scale
Standard Deviation 2.596
|
-3.78 Score on a scale
Standard Deviation 2.092
|
-2.35 Score on a scale
Standard Deviation 2.788
|
-2.16 Score on a scale
Standard Deviation 3.870
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 51
|
-2.39 Score on a scale
Standard Deviation 2.399
|
-1.80 Score on a scale
Standard Deviation 2.860
|
-4.64 Score on a scale
Standard Deviation 3.094
|
-2.67 Score on a scale
Standard Deviation 3.188
|
-2.42 Score on a scale
Standard Deviation 3.317
|
-1.89 Score on a scale
Standard Deviation 2.692
|
-3.66 Score on a scale
Standard Deviation 2.014
|
-2.40 Score on a scale
Standard Deviation 2.777
|
-2.12 Score on a scale
Standard Deviation 3.883
|
|
Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 52
|
-2.53 Score on a scale
Standard Deviation 2.917
|
-1.84 Score on a scale
Standard Deviation 2.779
|
-4.74 Score on a scale
Standard Deviation 2.909
|
-2.70 Score on a scale
Standard Deviation 3.119
|
-2.17 Score on a scale
Standard Deviation 3.152
|
-1.84 Score on a scale
Standard Deviation 2.929
|
-3.86 Score on a scale
Standard Deviation 2.135
|
-2.33 Score on a scale
Standard Deviation 2.811
|
-2.12 Score on a scale
Standard Deviation 3.904
|
SECONDARY outcome
Timeframe: Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Only those participants with data available at specified time points are reported.
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 1
|
-6.18 Percentage of change
Standard Deviation 13.809
|
-6.05 Percentage of change
Standard Deviation 13.049
|
-3.70 Percentage of change
Standard Deviation 16.432
|
-6.26 Percentage of change
Standard Deviation 16.312
|
-7.25 Percentage of change
Standard Deviation 13.575
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 2
|
-9.86 Percentage of change
Standard Deviation 14.734
|
-11.20 Percentage of change
Standard Deviation 18.124
|
-5.63 Percentage of change
Standard Deviation 15.340
|
-7.50 Percentage of change
Standard Deviation 20.644
|
-10.37 Percentage of change
Standard Deviation 19.307
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 3
|
-14.11 Percentage of change
Standard Deviation 17.784
|
-12.08 Percentage of change
Standard Deviation 22.244
|
-7.89 Percentage of change
Standard Deviation 22.004
|
-11.08 Percentage of change
Standard Deviation 24.712
|
-12.11 Percentage of change
Standard Deviation 18.977
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 4
|
-18.37 Percentage of change
Standard Deviation 19.932
|
-14.95 Percentage of change
Standard Deviation 24.356
|
-9.83 Percentage of change
Standard Deviation 24.266
|
-12.16 Percentage of change
Standard Deviation 25.287
|
-16.73 Percentage of change
Standard Deviation 22.997
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 5
|
-19.20 Percentage of change
Standard Deviation 21.900
|
-20.17 Percentage of change
Standard Deviation 25.112
|
-10.14 Percentage of change
Standard Deviation 29.071
|
-12.58 Percentage of change
Standard Deviation 27.613
|
-18.64 Percentage of change
Standard Deviation 23.725
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 6
|
-18.68 Percentage of change
Standard Deviation 22.790
|
-21.29 Percentage of change
Standard Deviation 28.179
|
-12.43 Percentage of change
Standard Deviation 27.184
|
-13.73 Percentage of change
Standard Deviation 25.374
|
-17.59 Percentage of change
Standard Deviation 25.814
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 7
|
-21.18 Percentage of change
Standard Deviation 23.816
|
-24.03 Percentage of change
Standard Deviation 27.650
|
-10.18 Percentage of change
Standard Deviation 28.308
|
-15.89 Percentage of change
Standard Deviation 28.992
|
-20.18 Percentage of change
Standard Deviation 25.476
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 8
|
-21.14 Percentage of change
Standard Deviation 24.981
|
-26.10 Percentage of change
Standard Deviation 27.810
|
-10.51 Percentage of change
Standard Deviation 29.803
|
-18.41 Percentage of change
Standard Deviation 31.375
|
-19.99 Percentage of change
Standard Deviation 24.992
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 9
|
-25.45 Percentage of change
Standard Deviation 24.895
|
-29.18 Percentage of change
Standard Deviation 27.455
|
-13.34 Percentage of change
Standard Deviation 32.225
|
-18.83 Percentage of change
Standard Deviation 32.003
|
-20.36 Percentage of change
Standard Deviation 25.407
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 10
|
-24.46 Percentage of change
Standard Deviation 28.280
|
-29.43 Percentage of change
Standard Deviation 28.109
|
-12.99 Percentage of change
Standard Deviation 33.194
|
-21.19 Percentage of change
Standard Deviation 32.110
|
-22.53 Percentage of change
Standard Deviation 25.815
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 11
|
-27.67 Percentage of change
Standard Deviation 28.079
|
-31.26 Percentage of change
Standard Deviation 29.641
|
-12.73 Percentage of change
Standard Deviation 31.638
|
-21.93 Percentage of change
Standard Deviation 31.966
|
-22.37 Percentage of change
Standard Deviation 26.321
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 12
|
-26.52 Percentage of change
Standard Deviation 28.426
|
-31.23 Percentage of change
Standard Deviation 30.323
|
-10.62 Percentage of change
Standard Deviation 32.707
|
-22.59 Percentage of change
Standard Deviation 32.927
|
-22.05 Percentage of change
Standard Deviation 28.445
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 13
|
-28.18 Percentage of change
Standard Deviation 29.401
|
-31.36 Percentage of change
Standard Deviation 31.724
|
-10.05 Percentage of change
Standard Deviation 32.122
|
-23.88 Percentage of change
Standard Deviation 33.561
|
-24.71 Percentage of change
Standard Deviation 30.761
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 14
|
-29.19 Percentage of change
Standard Deviation 30.904
|
-32.57 Percentage of change
Standard Deviation 31.719
|
-7.60 Percentage of change
Standard Deviation 31.351
|
-23.87 Percentage of change
Standard Deviation 34.926
|
-26.45 Percentage of change
Standard Deviation 32.870
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 15
|
-28.87 Percentage of change
Standard Deviation 31.207
|
-32.01 Percentage of change
Standard Deviation 30.980
|
-6.87 Percentage of change
Standard Deviation 29.583
|
-24.40 Percentage of change
Standard Deviation 34.899
|
-27.46 Percentage of change
Standard Deviation 33.838
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 16
|
-30.75 Percentage of change
Standard Deviation 30.460
|
-31.97 Percentage of change
Standard Deviation 31.194
|
-6.62 Percentage of change
Standard Deviation 30.591
|
-26.85 Percentage of change
Standard Deviation 36.332
|
-27.92 Percentage of change
Standard Deviation 33.619
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 17
|
-29.68 Percentage of change
Standard Deviation 31.753
|
-32.60 Percentage of change
Standard Deviation 31.851
|
-7.46 Percentage of change
Standard Deviation 31.529
|
-27.81 Percentage of change
Standard Deviation 35.262
|
-29.27 Percentage of change
Standard Deviation 33.331
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 18
|
-29.89 Percentage of change
Standard Deviation 31.200
|
-32.50 Percentage of change
Standard Deviation 32.096
|
-6.37 Percentage of change
Standard Deviation 31.752
|
-28.78 Percentage of change
Standard Deviation 36.738
|
-29.49 Percentage of change
Standard Deviation 34.514
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 19
|
-29.83 Percentage of change
Standard Deviation 31.632
|
-32.77 Percentage of change
Standard Deviation 33.698
|
-9.50 Percentage of change
Standard Deviation 33.411
|
-28.98 Percentage of change
Standard Deviation 36.372
|
-29.78 Percentage of change
Standard Deviation 35.087
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 20
|
-29.48 Percentage of change
Standard Deviation 32.361
|
-31.85 Percentage of change
Standard Deviation 32.767
|
-8.56 Percentage of change
Standard Deviation 32.725
|
-30.61 Percentage of change
Standard Deviation 37.215
|
-29.30 Percentage of change
Standard Deviation 34.365
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 21
|
-31.61 Percentage of change
Standard Deviation 32.551
|
-33.20 Percentage of change
Standard Deviation 33.098
|
-9.71 Percentage of change
Standard Deviation 34.201
|
-30.40 Percentage of change
Standard Deviation 36.928
|
-29.63 Percentage of change
Standard Deviation 34.869
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 22
|
-31.15 Percentage of change
Standard Deviation 33.763
|
-33.28 Percentage of change
Standard Deviation 32.108
|
-9.36 Percentage of change
Standard Deviation 34.161
|
-31.81 Percentage of change
Standard Deviation 38.100
|
-30.35 Percentage of change
Standard Deviation 36.881
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 23
|
-30.52 Percentage of change
Standard Deviation 35.354
|
-35.25 Percentage of change
Standard Deviation 33.102
|
-7.23 Percentage of change
Standard Deviation 32.486
|
-34.26 Percentage of change
Standard Deviation 38.693
|
-30.30 Percentage of change
Standard Deviation 35.236
|
—
|
—
|
—
|
—
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)
Week 24
|
-30.64 Percentage of change
Standard Deviation 36.647
|
-33.26 Percentage of change
Standard Deviation 32.433
|
-6.66 Percentage of change
Standard Deviation 32.550
|
-34.70 Percentage of change
Standard Deviation 38.656
|
-30.44 Percentage of change
Standard Deviation 36.696
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, & 52Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at week 24. Only those participants with data available at specified time points are reported.
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 24
|
-52.36 Percentage of change
Standard Deviation 33.258
|
-29.76 Percentage of change
Standard Deviation 40.611
|
-56.60 Percentage of change
Standard Deviation 24.568
|
-49.61 Percentage of change
Standard Deviation 33.036
|
-38.71 Percentage of change
Standard Deviation 44.259
|
-42.27 Percentage of change
Standard Deviation 36.685
|
-59.49 Percentage of change
Standard Deviation 22.140
|
-38.95 Percentage of change
Standard Deviation 34.963
|
-29.09 Percentage of change
Standard Deviation 44.653
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 25
|
-53.26 Percentage of change
Standard Deviation 33.810
|
-31.69 Percentage of change
Standard Deviation 40.647
|
-54.31 Percentage of change
Standard Deviation 29.223
|
-52.15 Percentage of change
Standard Deviation 31.579
|
-36.78 Percentage of change
Standard Deviation 45.402
|
-41.26 Percentage of change
Standard Deviation 34.643
|
-63.84 Percentage of change
Standard Deviation 23.417
|
-37.04 Percentage of change
Standard Deviation 36.046
|
-30.81 Percentage of change
Standard Deviation 46.001
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 26
|
-48.88 Percentage of change
Standard Deviation 32.071
|
-30.68 Percentage of change
Standard Deviation 42.883
|
-50.31 Percentage of change
Standard Deviation 29.134
|
-51.62 Percentage of change
Standard Deviation 32.197
|
-36.84 Percentage of change
Standard Deviation 44.342
|
-38.14 Percentage of change
Standard Deviation 35.393
|
-57.52 Percentage of change
Standard Deviation 22.280
|
-37.71 Percentage of change
Standard Deviation 37.451
|
-28.48 Percentage of change
Standard Deviation 46.252
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 27
|
-47.36 Percentage of change
Standard Deviation 30.909
|
-29.42 Percentage of change
Standard Deviation 40.379
|
-53.62 Percentage of change
Standard Deviation 30.255
|
-52.09 Percentage of change
Standard Deviation 32.613
|
-35.34 Percentage of change
Standard Deviation 44.056
|
-42.65 Percentage of change
Standard Deviation 36.665
|
-57.00 Percentage of change
Standard Deviation 20.810
|
-35.32 Percentage of change
Standard Deviation 38.963
|
-29.92 Percentage of change
Standard Deviation 48.506
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 28
|
-47.19 Percentage of change
Standard Deviation 31.551
|
-30.58 Percentage of change
Standard Deviation 38.398
|
-53.08 Percentage of change
Standard Deviation 30.684
|
-52.36 Percentage of change
Standard Deviation 32.642
|
-34.80 Percentage of change
Standard Deviation 45.063
|
-44.86 Percentage of change
Standard Deviation 36.493
|
-56.28 Percentage of change
Standard Deviation 24.247
|
-38.37 Percentage of change
Standard Deviation 38.703
|
-27.74 Percentage of change
Standard Deviation 49.936
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 29
|
-50.29 Percentage of change
Standard Deviation 29.286
|
-24.35 Percentage of change
Standard Deviation 38.746
|
-54.93 Percentage of change
Standard Deviation 28.705
|
-50.48 Percentage of change
Standard Deviation 35.634
|
-34.13 Percentage of change
Standard Deviation 44.735
|
-44.31 Percentage of change
Standard Deviation 37.579
|
-56.79 Percentage of change
Standard Deviation 23.453
|
-36.46 Percentage of change
Standard Deviation 38.211
|
-26.40 Percentage of change
Standard Deviation 48.994
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 30
|
-49.35 Percentage of change
Standard Deviation 28.435
|
-28.00 Percentage of change
Standard Deviation 35.916
|
-58.70 Percentage of change
Standard Deviation 30.600
|
-44.79 Percentage of change
Standard Deviation 34.219
|
-37.91 Percentage of change
Standard Deviation 46.288
|
-40.30 Percentage of change
Standard Deviation 37.098
|
-48.05 Percentage of change
Standard Deviation 24.892
|
-36.03 Percentage of change
Standard Deviation 38.742
|
-26.58 Percentage of change
Standard Deviation 49.832
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 31
|
-49.01 Percentage of change
Standard Deviation 28.581
|
-21.78 Percentage of change
Standard Deviation 41.439
|
-55.77 Percentage of change
Standard Deviation 30.420
|
-46.03 Percentage of change
Standard Deviation 34.355
|
-37.18 Percentage of change
Standard Deviation 49.311
|
-42.26 Percentage of change
Standard Deviation 39.161
|
-52.67 Percentage of change
Standard Deviation 29.311
|
-39.45 Percentage of change
Standard Deviation 38.697
|
-21.51 Percentage of change
Standard Deviation 44.331
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 32
|
-40.69 Percentage of change
Standard Deviation 34.523
|
-19.61 Percentage of change
Standard Deviation 37.935
|
-57.32 Percentage of change
Standard Deviation 29.140
|
-46.40 Percentage of change
Standard Deviation 35.233
|
-34.68 Percentage of change
Standard Deviation 47.719
|
-42.64 Percentage of change
Standard Deviation 38.113
|
-56.51 Percentage of change
Standard Deviation 27.668
|
-37.63 Percentage of change
Standard Deviation 38.453
|
-22.64 Percentage of change
Standard Deviation 46.122
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 33
|
-39.31 Percentage of change
Standard Deviation 33.036
|
-24.61 Percentage of change
Standard Deviation 39.502
|
-57.76 Percentage of change
Standard Deviation 29.406
|
-48.66 Percentage of change
Standard Deviation 36.625
|
-33.52 Percentage of change
Standard Deviation 48.881
|
-42.45 Percentage of change
Standard Deviation 38.100
|
-52.89 Percentage of change
Standard Deviation 22.337
|
-37.50 Percentage of change
Standard Deviation 39.368
|
-21.49 Percentage of change
Standard Deviation 48.348
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 34
|
-43.33 Percentage of change
Standard Deviation 34.277
|
-17.18 Percentage of change
Standard Deviation 39.855
|
-59.41 Percentage of change
Standard Deviation 29.414
|
-47.09 Percentage of change
Standard Deviation 35.098
|
-30.56 Percentage of change
Standard Deviation 48.227
|
-42.96 Percentage of change
Standard Deviation 37.718
|
-50.34 Percentage of change
Standard Deviation 22.937
|
-35.63 Percentage of change
Standard Deviation 37.586
|
-27.22 Percentage of change
Standard Deviation 51.629
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 35
|
-40.21 Percentage of change
Standard Deviation 32.239
|
-18.51 Percentage of change
Standard Deviation 37.670
|
-61.70 Percentage of change
Standard Deviation 32.381
|
-46.67 Percentage of change
Standard Deviation 36.047
|
-33.99 Percentage of change
Standard Deviation 48.416
|
-44.99 Percentage of change
Standard Deviation 37.080
|
-58.12 Percentage of change
Standard Deviation 24.772
|
-36.74 Percentage of change
Standard Deviation 37.592
|
-27.11 Percentage of change
Standard Deviation 48.897
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 36
|
-36.23 Percentage of change
Standard Deviation 33.872
|
-22.43 Percentage of change
Standard Deviation 37.322
|
-62.54 Percentage of change
Standard Deviation 31.831
|
-46.63 Percentage of change
Standard Deviation 36.326
|
-33.43 Percentage of change
Standard Deviation 48.720
|
-43.37 Percentage of change
Standard Deviation 37.251
|
-52.78 Percentage of change
Standard Deviation 22.120
|
-33.66 Percentage of change
Standard Deviation 38.520
|
-22.57 Percentage of change
Standard Deviation 47.897
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 37
|
-32.60 Percentage of change
Standard Deviation 31.909
|
-25.63 Percentage of change
Standard Deviation 39.489
|
-60.49 Percentage of change
Standard Deviation 31.510
|
-45.95 Percentage of change
Standard Deviation 35.161
|
-34.42 Percentage of change
Standard Deviation 48.542
|
-46.52 Percentage of change
Standard Deviation 37.336
|
-58.05 Percentage of change
Standard Deviation 27.565
|
-33.22 Percentage of change
Standard Deviation 38.367
|
-22.63 Percentage of change
Standard Deviation 48.038
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 38
|
-26.80 Percentage of change
Standard Deviation 31.244
|
-24.20 Percentage of change
Standard Deviation 40.063
|
-60.83 Percentage of change
Standard Deviation 31.559
|
-43.12 Percentage of change
Standard Deviation 42.814
|
-31.62 Percentage of change
Standard Deviation 47.534
|
-47.17 Percentage of change
Standard Deviation 39.147
|
-58.43 Percentage of change
Standard Deviation 27.410
|
-33.72 Percentage of change
Standard Deviation 37.516
|
-24.07 Percentage of change
Standard Deviation 49.645
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 39
|
-32.75 Percentage of change
Standard Deviation 31.185
|
-25.49 Percentage of change
Standard Deviation 40.126
|
-56.79 Percentage of change
Standard Deviation 31.763
|
-43.54 Percentage of change
Standard Deviation 42.937
|
-31.75 Percentage of change
Standard Deviation 48.313
|
-46.10 Percentage of change
Standard Deviation 38.082
|
-59.36 Percentage of change
Standard Deviation 25.162
|
-32.70 Percentage of change
Standard Deviation 38.945
|
-25.98 Percentage of change
Standard Deviation 48.229
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 40
|
-27.37 Percentage of change
Standard Deviation 25.233
|
-24.24 Percentage of change
Standard Deviation 38.972
|
-56.78 Percentage of change
Standard Deviation 31.397
|
-42.94 Percentage of change
Standard Deviation 43.748
|
-30.52 Percentage of change
Standard Deviation 48.657
|
-43.62 Percentage of change
Standard Deviation 38.048
|
-38.57 Percentage of change
Standard Deviation 22.074
|
-34.20 Percentage of change
Standard Deviation 39.168
|
-24.22 Percentage of change
Standard Deviation 49.044
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 41
|
-22.99 Percentage of change
Standard Deviation 23.218
|
-27.38 Percentage of change
Standard Deviation 39.966
|
-61.18 Percentage of change
Standard Deviation 30.487
|
-42.33 Percentage of change
Standard Deviation 43.065
|
-30.85 Percentage of change
Standard Deviation 48.900
|
-39.66 Percentage of change
Standard Deviation 42.054
|
-47.95 Percentage of change
Standard Deviation 26.092
|
-34.51 Percentage of change
Standard Deviation 40.123
|
-24.13 Percentage of change
Standard Deviation 55.219
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 42
|
-34.23 Percentage of change
Standard Deviation 35.319
|
-26.33 Percentage of change
Standard Deviation 40.513
|
-62.53 Percentage of change
Standard Deviation 32.149
|
-41.68 Percentage of change
Standard Deviation 42.874
|
-30.76 Percentage of change
Standard Deviation 50.332
|
-42.91 Percentage of change
Standard Deviation 42.866
|
-49.33 Percentage of change
Standard Deviation 29.448
|
-32.01 Percentage of change
Standard Deviation 39.405
|
-29.48 Percentage of change
Standard Deviation 53.423
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 43
|
-33.86 Percentage of change
Standard Deviation 33.053
|
-23.93 Percentage of change
Standard Deviation 40.455
|
-62.27 Percentage of change
Standard Deviation 36.647
|
-42.86 Percentage of change
Standard Deviation 43.495
|
-30.51 Percentage of change
Standard Deviation 48.200
|
-41.66 Percentage of change
Standard Deviation 38.115
|
-48.09 Percentage of change
Standard Deviation 26.148
|
-31.34 Percentage of change
Standard Deviation 41.919
|
-33.70 Percentage of change
Standard Deviation 54.865
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 44
|
-31.76 Percentage of change
Standard Deviation 30.960
|
-24.67 Percentage of change
Standard Deviation 37.725
|
-64.61 Percentage of change
Standard Deviation 31.787
|
-43.47 Percentage of change
Standard Deviation 44.000
|
-31.71 Percentage of change
Standard Deviation 49.607
|
-42.36 Percentage of change
Standard Deviation 40.085
|
-46.04 Percentage of change
Standard Deviation 28.399
|
-31.28 Percentage of change
Standard Deviation 40.103
|
-29.07 Percentage of change
Standard Deviation 53.672
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 45
|
-25.91 Percentage of change
Standard Deviation 26.492
|
-25.91 Percentage of change
Standard Deviation 38.680
|
-61.59 Percentage of change
Standard Deviation 33.745
|
-47.27 Percentage of change
Standard Deviation 40.996
|
-33.33 Percentage of change
Standard Deviation 50.319
|
-39.63 Percentage of change
Standard Deviation 39.211
|
-47.19 Percentage of change
Standard Deviation 28.645
|
-31.41 Percentage of change
Standard Deviation 39.716
|
-27.07 Percentage of change
Standard Deviation 54.016
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 46
|
-34.27 Percentage of change
Standard Deviation 33.932
|
-25.58 Percentage of change
Standard Deviation 38.019
|
-58.81 Percentage of change
Standard Deviation 35.801
|
-42.11 Percentage of change
Standard Deviation 45.119
|
-33.68 Percentage of change
Standard Deviation 49.356
|
-34.77 Percentage of change
Standard Deviation 38.757
|
-49.76 Percentage of change
Standard Deviation 30.190
|
-31.98 Percentage of change
Standard Deviation 39.640
|
-28.89 Percentage of change
Standard Deviation 58.573
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 47
|
-25.60 Percentage of change
Standard Deviation 30.211
|
-25.44 Percentage of change
Standard Deviation 39.798
|
-59.01 Percentage of change
Standard Deviation 35.211
|
-40.77 Percentage of change
Standard Deviation 44.580
|
-31.88 Percentage of change
Standard Deviation 48.778
|
-33.49 Percentage of change
Standard Deviation 39.386
|
-48.45 Percentage of change
Standard Deviation 30.519
|
-33.71 Percentage of change
Standard Deviation 38.282
|
-25.86 Percentage of change
Standard Deviation 54.094
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 48
|
-30.33 Percentage of change
Standard Deviation 30.351
|
-25.04 Percentage of change
Standard Deviation 38.230
|
-61.01 Percentage of change
Standard Deviation 35.650
|
-36.53 Percentage of change
Standard Deviation 44.443
|
-33.50 Percentage of change
Standard Deviation 48.912
|
-29.89 Percentage of change
Standard Deviation 38.681
|
-51.75 Percentage of change
Standard Deviation 30.214
|
-33.16 Percentage of change
Standard Deviation 40.239
|
-29.29 Percentage of change
Standard Deviation 53.432
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 49
|
-34.64 Percentage of change
Standard Deviation 34.631
|
-28.21 Percentage of change
Standard Deviation 41.352
|
-61.21 Percentage of change
Standard Deviation 35.897
|
-36.35 Percentage of change
Standard Deviation 44.233
|
-31.23 Percentage of change
Standard Deviation 48.493
|
-29.37 Percentage of change
Standard Deviation 38.374
|
-48.17 Percentage of change
Standard Deviation 27.760
|
-34.32 Percentage of change
Standard Deviation 41.018
|
-29.80 Percentage of change
Standard Deviation 55.717
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 50
|
-32.01 Percentage of change
Standard Deviation 36.290
|
-26.10 Percentage of change
Standard Deviation 40.637
|
-59.59 Percentage of change
Standard Deviation 36.330
|
-36.14 Percentage of change
Standard Deviation 44.279
|
-31.62 Percentage of change
Standard Deviation 50.758
|
-27.45 Percentage of change
Standard Deviation 38.441
|
-50.18 Percentage of change
Standard Deviation 30.773
|
-32.86 Percentage of change
Standard Deviation 40.330
|
-31.15 Percentage of change
Standard Deviation 55.571
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 51
|
-30.83 Percentage of change
Standard Deviation 31.211
|
-24.47 Percentage of change
Standard Deviation 39.779
|
-60.72 Percentage of change
Standard Deviation 38.664
|
-34.31 Percentage of change
Standard Deviation 43.008
|
-34.07 Percentage of change
Standard Deviation 51.575
|
-27.10 Percentage of change
Standard Deviation 39.790
|
-48.66 Percentage of change
Standard Deviation 29.191
|
-33.72 Percentage of change
Standard Deviation 40.790
|
-30.75 Percentage of change
Standard Deviation 55.841
|
|
Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)
Week 52
|
-33.29 Percentage of change
Standard Deviation 38.191
|
-25.37 Percentage of change
Standard Deviation 39.165
|
-61.83 Percentage of change
Standard Deviation 35.861
|
-35.06 Percentage of change
Standard Deviation 42.961
|
-30.54 Percentage of change
Standard Deviation 49.791
|
-25.94 Percentage of change
Standard Deviation 43.683
|
-50.89 Percentage of change
Standard Deviation 29.752
|
-32.36 Percentage of change
Standard Deviation 40.612
|
-30.50 Percentage of change
Standard Deviation 56.024
|
SECONDARY outcome
Timeframe: Baseline to weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, & 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to week 24. Participants with missing data were considered as non-responders.
The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the 'worst itch imaginable'.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=79 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=79 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 24
|
36.4 Percentage of participants
|
39.2 Percentage of participants
|
11.4 Percentage of participants
|
40.3 Percentage of participants
|
30.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 1
|
1.3 Percentage of participants
|
1.3 Percentage of participants
|
1.3 Percentage of participants
|
2.6 Percentage of participants
|
1.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 2
|
1.3 Percentage of participants
|
6.3 Percentage of participants
|
2.5 Percentage of participants
|
3.9 Percentage of participants
|
6.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 3
|
10.4 Percentage of participants
|
7.6 Percentage of participants
|
6.3 Percentage of participants
|
9.1 Percentage of participants
|
6.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 4
|
15.6 Percentage of participants
|
13.9 Percentage of participants
|
7.6 Percentage of participants
|
10.4 Percentage of participants
|
14.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 5
|
16.9 Percentage of participants
|
19.0 Percentage of participants
|
11.4 Percentage of participants
|
15.6 Percentage of participants
|
15.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 6
|
18.2 Percentage of participants
|
21.5 Percentage of participants
|
12.7 Percentage of participants
|
10.4 Percentage of participants
|
19.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 7
|
20.8 Percentage of participants
|
25.3 Percentage of participants
|
11.4 Percentage of participants
|
16.9 Percentage of participants
|
23.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 8
|
22.1 Percentage of participants
|
26.6 Percentage of participants
|
15.2 Percentage of participants
|
22.1 Percentage of participants
|
17.9 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 9
|
27.3 Percentage of participants
|
31.6 Percentage of participants
|
13.9 Percentage of participants
|
20.8 Percentage of participants
|
19.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 10
|
28.6 Percentage of participants
|
38.0 Percentage of participants
|
15.2 Percentage of participants
|
27.3 Percentage of participants
|
23.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 11
|
31.2 Percentage of participants
|
36.7 Percentage of participants
|
13.9 Percentage of participants
|
26.0 Percentage of participants
|
23.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 12
|
28.6 Percentage of participants
|
38.0 Percentage of participants
|
16.5 Percentage of participants
|
26.0 Percentage of participants
|
20.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 13
|
29.9 Percentage of participants
|
38.0 Percentage of participants
|
13.9 Percentage of participants
|
28.6 Percentage of participants
|
26.9 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 14
|
28.6 Percentage of participants
|
40.5 Percentage of participants
|
13.9 Percentage of participants
|
35.1 Percentage of participants
|
29.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 15
|
28.6 Percentage of participants
|
40.5 Percentage of participants
|
10.1 Percentage of participants
|
29.9 Percentage of participants
|
28.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 16
|
29.9 Percentage of participants
|
41.8 Percentage of participants
|
10.1 Percentage of participants
|
32.5 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 17
|
27.3 Percentage of participants
|
38.0 Percentage of participants
|
13.9 Percentage of participants
|
32.5 Percentage of participants
|
30.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 18
|
29.9 Percentage of participants
|
43.0 Percentage of participants
|
12.7 Percentage of participants
|
36.4 Percentage of participants
|
33.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 19
|
33.8 Percentage of participants
|
43.0 Percentage of participants
|
15.2 Percentage of participants
|
35.1 Percentage of participants
|
32.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 20
|
31.2 Percentage of participants
|
36.7 Percentage of participants
|
10.1 Percentage of participants
|
33.8 Percentage of participants
|
30.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 21
|
33.8 Percentage of participants
|
36.7 Percentage of participants
|
15.2 Percentage of participants
|
37.7 Percentage of participants
|
32.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 22
|
33.8 Percentage of participants
|
39.2 Percentage of participants
|
13.9 Percentage of participants
|
37.7 Percentage of participants
|
30.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)
Week 23
|
37.7 Percentage of participants
|
43.0 Percentage of participants
|
12.7 Percentage of participants
|
41.6 Percentage of participants
|
35.9 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 to week 52Population: Participants who reached EASI 50 at week 24 and re-randomized participants at week 24.
The incidence rate of loss of EASI 50 is calculated for participants who achieved EASI 50 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 50 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 50) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Incidence Rate of Loss of EASI 50 (Part 2)
|
0.188 Events per patient-year
|
0.089 Events per patient-year
|
0.165 Events per patient-year
|
0 Events per patient-year
|
0.272 Events per patient-year
|
0.071 Events per patient-year
|
0 Events per patient-year
|
0.193 Events per patient-year
|
0.145 Events per patient-year
|
SECONDARY outcome
Timeframe: Week 24 to week 52Population: Participants who reached EASI 75 at week 24 and re-randomized participants at week 24.
The incidence rate of loss of EASI 75 is calculated for participants who achieved EASI 75 at re-randomization (week 24). The incidence rate is computed as the number of participants losing EASI 75 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of EASI 75) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=27 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=11 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=12 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Incidence Rate of Loss of EASI 75 (Part 2)
|
0.375 Events per patient-year
|
0.486 Events per patient-year
|
0.395 Events per patient-year
|
0 Events per patient-year
|
0.587 Events per patient-year
|
0.446 Events per patient-year
|
0.351 Events per patient-year
|
0.573 Events per patient-year
|
0.646 Events per patient-year
|
SECONDARY outcome
Timeframe: Week 24 to week 68Population: Participants who had IGA response 0 or 1 at week 24 and re-randomized at week 24.
The incidence rate of loss of IGA 0/1 is calculated for participants who achieved IGA 0/1 at re-randomization (week 24). The incidence rate is computed as the number of participants losing IGA 0/1 divided by total follow-up time. The follow-up time is defined as the duration from re-randomization (week 24) to either the first event date (loss of IGA 0/1) or censoring date for participants who had no events. The censoring date is defined as the earliest occurrence of: use of rescue medications and/or selected prohibited medications/ procedures impacting efficacy, or study discontinuation/ completion.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=12 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=35 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=16 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Incidence Rate of Loss of IGA 0/1 (Part 2)
|
0.981 Events per patient-year
|
1.930 Events per patient-year
|
1.154 Events per patient-year
|
1.267 Events per patient-year
|
1.039 Events per patient-year
|
1.045 Events per patient-year
|
1.096 Events per patient-year
|
1.790 Events per patient-year
|
0.244 Events per patient-year
|
SECONDARY outcome
Timeframe: Baseline and at weeks 1, 2, 4, 8, 12, 16, 17, 20, & 24Population: This analysis was conducted for Part 1 and includes participants who took at least one dose of KY1005. Only those participants with data available at specified timepoints are reported.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=76 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)
Baseline
|
0.01 (ug/ml)
Standard Deviation 0.074
|
0.00 (ug/ml)
Standard Deviation 0.000
|
—
|
0.00 (ug/ml)
Standard Deviation 0.014
|
0.00 (ug/ml)
Standard Deviation 0.014
|
—
|
—
|
—
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)
Week 1
|
14.18 (ug/ml)
Standard Deviation 5.060
|
8.49 (ug/ml)
Standard Deviation 3.331
|
—
|
58.29 (ug/ml)
Standard Deviation 24.674
|
30.49 (ug/ml)
Standard Deviation 18.520
|
—
|
—
|
—
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)
Week 2
|
13.56 (ug/ml)
Standard Deviation 3.886
|
7.57 (ug/ml)
Standard Deviation 2.947
|
—
|
47.56 (ug/ml)
Standard Deviation 17.274
|
25.09 (ug/ml)
Standard Deviation 9.041
|
—
|
—
|
—
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)
Week 4
|
9.67 (ug/ml)
Standard Deviation 3.728
|
5.09 (ug/ml)
Standard Deviation 2.176
|
—
|
38.49 (ug/ml)
Standard Deviation 22.532
|
19.00 (ug/ml)
Standard Deviation 7.869
|
—
|
—
|
—
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)
Week 8
|
15.07 (ug/ml)
Standard Deviation 6.383
|
7.92 (ug/ml)
Standard Deviation 3.263
|
—
|
37.67 (ug/ml)
Standard Deviation 15.157
|
32.14 (ug/ml)
Standard Deviation 16.502
|
—
|
—
|
—
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)
Week 12
|
18.12 (ug/ml)
Standard Deviation 8.439
|
9.22 (ug/ml)
Standard Deviation 4.116
|
—
|
39.26 (ug/ml)
Standard Deviation 33.847
|
34.67 (ug/ml)
Standard Deviation 15.191
|
—
|
—
|
—
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)
Week 16
|
18.39 (ug/ml)
Standard Deviation 7.245
|
10.13 (ug/ml)
Standard Deviation 4.515
|
—
|
40.12 (ug/ml)
Standard Deviation 28.610
|
38.09 (ug/ml)
Standard Deviation 13.536
|
—
|
—
|
—
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)
Week 17
|
29.26 (ug/ml)
Standard Deviation 11.659
|
16.79 (ug/ml)
Standard Deviation 6.677
|
—
|
62.34 (ug/ml)
Standard Deviation 28.081
|
64.64 (ug/ml)
Standard Deviation 24.169
|
—
|
—
|
—
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)
Week 20
|
19.31 (ug/ml)
Standard Deviation 7.203
|
10.68 (ug/ml)
Standard Deviation 3.715
|
—
|
37.92 (ug/ml)
Standard Deviation 14.171
|
48.26 (ug/ml)
Standard Deviation 30.691
|
—
|
—
|
—
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 1)
Week 24
|
20.25 (ug/ml)
Standard Deviation 10.575
|
11.07 (ug/ml)
Standard Deviation 3.918
|
—
|
41.98 (ug/ml)
Standard Deviation 23.087
|
43.81 (ug/ml)
Standard Deviation 17.403
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and at weeks 24, 25, 28, 32, 36, 40, 44, 48, & 52Population: This analysis was conducted for Part 2 and includes participants who took at least one dose of KY1005. Only those participants with data available at specified timepoints are reported
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=11 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=31 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 2)
Week 32
|
41.50 (ug/ml)
Standard Deviation 13.681
|
12.54 (ug/ml)
Standard Deviation 5.943
|
20.99 (ug/ml)
Standard Deviation 12.614
|
44.41 (ug/ml)
Standard Deviation 11.438
|
8.86 (ug/ml)
Standard Deviation 5.074
|
4.57 (ug/ml)
Standard Deviation 2.463
|
9.40 (ug/ml)
Standard Deviation 1.749
|
3.32 (ug/ml)
Standard Deviation 1.588
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 2)
Week 36
|
51.42 (ug/ml)
Standard Deviation 18.946
|
7.80 (ug/ml)
Standard Deviation 4.413
|
22.28 (ug/ml)
Standard Deviation 18.101
|
43.11 (ug/ml)
Standard Deviation 18.965
|
5.41 (ug/ml)
Standard Deviation 3.876
|
2.85 (ug/ml)
Standard Deviation 2.275
|
13.38 (ug/ml)
Standard Deviation 2.128
|
1.77 (ug/ml)
Standard Deviation 1.018
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 2)
Week 52
|
45.59 (ug/ml)
Standard Deviation 22.447
|
0.55 (ug/ml)
Standard Deviation 0.573
|
22.60 (ug/ml)
Standard Deviation 8.225
|
38.88 (ug/ml)
Standard Deviation 11.526
|
0.56 (ug/ml)
Standard Deviation 1.112
|
0.19 (ug/ml)
Standard Deviation 0.289
|
12.03 (ug/ml)
Standard Deviation 3.775
|
0.11 (ug/ml)
Standard Deviation 0.129
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 2)
Week 24
|
45.00 (ug/ml)
Standard Deviation 14.568
|
43.17 (ug/ml)
Standard Deviation 19.752
|
19.03 (ug/ml)
Standard Deviation 9.612
|
45.13 (ug/ml)
Standard Deviation 15.842
|
36.68 (ug/ml)
Standard Deviation 17.544
|
19.48 (ug/ml)
Standard Deviation 7.791
|
11.60 (ug/ml)
Standard Deviation 1.383
|
11.10 (ug/ml)
Standard Deviation 5.240
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 2)
Week 25
|
71.25 (ug/ml)
Standard Deviation 16.294
|
34.71 (ug/ml)
Standard Deviation 14.551
|
31.07 (ug/ml)
Standard Deviation 16.115
|
73.54 (ug/ml)
Standard Deviation 30.680
|
36.54 (ug/ml)
Standard Deviation 20.508
|
17.57 (ug/ml)
Standard Deviation 7.504
|
15.90 (ug/ml)
Standard Deviation 2.443
|
10.36 (ug/ml)
Standard Deviation 5.145
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 2)
Week 28
|
46.15 (ug/ml)
Standard Deviation 15.782
|
25.22 (ug/ml)
Standard Deviation 10.235
|
20.12 (ug/ml)
Standard Deviation 11.820
|
51.50 (ug/ml)
Standard Deviation 25.454
|
17.59 (ug/ml)
Standard Deviation 9.090
|
10.03 (ug/ml)
Standard Deviation 4.697
|
9.56 (ug/ml)
Standard Deviation 3.485
|
6.66 (ug/ml)
Standard Deviation 2.584
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 2)
Week 40
|
43.79 (ug/ml)
Standard Deviation 15.955
|
4.54 (ug/ml)
Standard Deviation 2.929
|
19.09 (ug/ml)
Standard Deviation 11.479
|
45.19 (ug/ml)
Standard Deviation 19.921
|
2.42 (ug/ml)
Standard Deviation 1.660
|
1.68 (ug/ml)
Standard Deviation 1.669
|
10.95 (ug/ml)
Standard Deviation 1.350
|
0.96 (ug/ml)
Standard Deviation 0.748
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 2)
Week 44
|
46.98 (ug/ml)
Standard Deviation 24.015
|
2.62 (ug/ml)
Standard Deviation 2.193
|
16.43 (ug/ml)
Standard Deviation 7.302
|
40.91 (ug/ml)
Standard Deviation 12.068
|
1.04 (ug/ml)
Standard Deviation 0.908
|
0.82 (ug/ml)
Standard Deviation 0.863
|
11.25 (ug/ml)
Standard Deviation 2.607
|
0.57 (ug/ml)
Standard Deviation 0.554
|
—
|
|
Serum KY1005 Concentration Assessed Throughout the Study (Part 2)
Week 48
|
43.63 (ug/ml)
Standard Deviation 22.188
|
1.40 (ug/ml)
Standard Deviation 1.727
|
17.80 (ug/ml)
Standard Deviation 9.065
|
41.43 (ug/ml)
Standard Deviation 14.214
|
0.58 (ug/ml)
Standard Deviation 0.507
|
0.42 (ug/ml)
Standard Deviation 0.483
|
11.12 (ug/ml)
Standard Deviation 1.825
|
0.25 (ug/ml)
Standard Deviation 0.305
|
—
|
SECONDARY outcome
Timeframe: Baseline through week 24Population: Safety Analysis Part 1:Participants who took at least a dose of study treatment, including placebo up to Week 24. Analysis based on the SAF1 was based on the treatment received, regardless of assigned treatment according to the randomization
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=78 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=78 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=78 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1)
Any Serious Treatment Emergent Adverse Event
|
1.3 Percentage of participants
|
6.4 Percentage of participants
|
1.3 Percentage of participants
|
2.6 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1)
Any Treatment Emergent Adverse Event
|
67.5 Percentage of participants
|
67.9 Percentage of participants
|
60.3 Percentage of participants
|
66.2 Percentage of participants
|
66.7 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24 through week 68Population: Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least a dose of study treatment on/or after Week 24. Any analysis based on the SAF2 was based on the treatment at Week 24, regardless of treatment according to the randomization.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=11 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=28 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=32 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=34 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
n=15 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2)
Any Serious Treatment Emergent Adverse Event
|
0 Percentage of participants
|
7.1 Percentage of participants
|
8.3 Percentage of participants
|
7.7 Percentage of participants
|
2.9 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2)
Any Treatment Emergent Adverse Event
|
63.6 Percentage of participants
|
78.6 Percentage of participants
|
66.7 Percentage of participants
|
84.6 Percentage of participants
|
67.6 Percentage of participants
|
87.5 Percentage of participants
|
57.1 Percentage of participants
|
67.6 Percentage of participants
|
66.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through week 24Population: The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=77 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=77 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=76 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent ADA (Part 1)
|
13.2 Percentage of participants
|
32.1 Percentage of participants
|
—
|
2.6 Percentage of participants
|
6.4 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through week 68Population: The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24.
Outcome measures
| Measure |
125 mg KY1005 (Part 1)
n=11 Participants
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=26 Participants
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=12 Participants
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-randomized From the 250mg (LD) Arm (Part 2)
n=13 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 250mg (LD) Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125mg Arm (Part 2)
n=31 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg KY1005 Re-randomized From the 62.5 mg Arm (Part 2)
n=7 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=33 Participants
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2) Continued From Part 1 Placebo
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Treatment-emergent ADA (Part 2)
|
9.1 Percentage of participants
|
19.2 Percentage of participants
|
0 Percentage of participants
|
7.7 Percentage of participants
|
9.1 Percentage of participants
|
35.5 Percentage of participants
|
28.6 Percentage of participants
|
42.4 Percentage of participants
|
—
|
Adverse Events
250 mg (500 mg LD) KY1005 (Part 1)
Serious events: 2 serious events
Other events: 42 other events
Deaths: 0 deaths
250 mg (no LD) KY1005 (Part 1)
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
125 mg KY1005 (Part 1)
Serious events: 1 serious events
Other events: 39 other events
Deaths: 0 deaths
62.5 mg KY1005 (Part 1)
Serious events: 5 serious events
Other events: 41 other events
Deaths: 0 deaths
Placebo (Part 1)
Serious events: 1 serious events
Other events: 41 other events
Deaths: 0 deaths
250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo (Part 2)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
250 mg (500 mg LD) KY1005 (Part 1)
n=77 participants at risk
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
|
250 mg (no LD) KY1005 (Part 1)
n=78 participants at risk
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
|
125 mg KY1005 (Part 1)
n=77 participants at risk
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=78 participants at risk
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=78 participants at risk
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)
n=13 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)
n=34 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
n=11 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)
n=28 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
n=12 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)
n=32 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)
n=7 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=34 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2)
n=15 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
7.7%
1/13 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.6%
1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
—
0/0 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
—
0/0 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.6%
1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
—
0/0 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.6%
1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Nervous system disorders
Tension Headache
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
—
0/0 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
—
0/0 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
—
0/0 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
Other adverse events
| Measure |
250 mg (500 mg LD) KY1005 (Part 1)
n=77 participants at risk
Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.
|
250 mg (no LD) KY1005 (Part 1)
n=78 participants at risk
Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.
|
125 mg KY1005 (Part 1)
n=77 participants at risk
Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.
|
62.5 mg KY1005 (Part 1)
n=78 participants at risk
Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.
|
Placebo (Part 1)
n=78 participants at risk
Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.
|
250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)
n=13 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)
n=34 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52
|
250 mg KY1005 Re-randomized From the 250 mg (No LD) Arm (Part 2)
n=11 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive KY1005 250mg Q4W from Week 24 to Week 52
|
Placebo Re-Randomized From the 250 mg (No LD) Arm (Part 2)
n=28 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)
n=12 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive KY1005 125 mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)
n=32 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)
n=7 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52
|
Placebo Re-randomized From the 62.5 mg Arm (Part 2)
n=34 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1) were rerandomized to receive placebo Q4W from Week 24 to Week 52
|
Placebo (Part 2)
n=15 participants at risk
Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
7.7%
1/13 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.6%
2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.6%
2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
7.1%
2/28 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
General disorders
FATIGUE
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
7.7%
1/13 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.2%
2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.8%
3/34 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
BRONCHITIS VIRAL
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.1%
1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
COVID-19
|
7.8%
6/77 • Number of events 6 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
9.0%
7/78 • Number of events 7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
9.1%
7/77 • Number of events 7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
5.1%
4/78 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.4%
5/78 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.6%
1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.1%
1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
14.3%
1/7 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
DERMATITIS INFECTED
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
11.8%
4/34 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
FOLLICULITIS
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/77 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.1%
1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
HERPES SIMPLEX
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
INFLUENZA
|
2.6%
2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.2%
2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
NASOPHARYNGITIS
|
18.2%
14/77 • Number of events 19 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
7.7%
6/78 • Number of events 8 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
11.7%
9/77 • Number of events 12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.4%
5/78 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
9.0%
7/78 • Number of events 10 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
15.4%
2/13 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
11.8%
4/34 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
7.1%
2/28 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
15.6%
5/32 • Number of events 6 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.8%
3/34 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
13.3%
2/15 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
ORAL HERPES
|
2.6%
2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.6%
1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.2%
2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
OTITIS Media
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.6%
1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
7.1%
2/28 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.2%
2/32 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
2.6%
2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
PYURIA
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
7.7%
1/13 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
RHINITIS
|
2.6%
2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.2%
2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
SINUSITIS
|
1.3%
1/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.2%
2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
TONSILLITIS
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.1%
1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
2.6%
2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.6%
2/78 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
5.2%
4/77 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.4%
5/78 • Number of events 6 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.4%
5/78 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
5.9%
2/34 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.1%
1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.8%
3/34 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
14.3%
1/7 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
2.6%
2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.8%
3/78 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.6%
2/77 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
5.1%
4/78 • Number of events 7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.6%
2/78 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
36.4%
4/11 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.1%
1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
13.3%
2/15 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.8%
3/78 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.6%
2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.2%
2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
14.3%
1/7 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.6%
2/77 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.6%
2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
5.2%
4/77 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.6%
2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.6%
2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.6%
2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.1%
1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
14.3%
1/7 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
5.9%
2/34 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.2%
2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.6%
2/78 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.2%
2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
14.3%
1/7 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Musculoskeletal and connective tissue disorders
PERIOSTITIS
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Musculoskeletal and connective tissue disorders
SPINAL PAIN
|
2.6%
2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
13.3%
2/15 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Nervous system disorders
DIZZINESS
|
2.6%
2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.6%
2/77 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Nervous system disorders
HEADACHE
|
5.2%
4/77 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
5.1%
4/78 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
5.2%
4/77 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
9.0%
7/78 • Number of events 7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.8%
3/78 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
15.4%
2/13 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.6%
1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
16.7%
2/12 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.2%
2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Nervous system disorders
TENSION HEADACHE
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
5.9%
2/34 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Reproductive system and breast disorders
HEAVY MENSTRUAL BLEEDING
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
2.6%
2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.6%
2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.6%
1/28 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
3.1%
1/32 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.7%
1/15 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
7.7%
1/13 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ATOPIC
|
11.7%
9/77 • Number of events 10 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
20.5%
16/78 • Number of events 22 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
19.5%
15/77 • Number of events 19 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
16.7%
13/78 • Number of events 14 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
38.5%
30/78 • Number of events 43 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
46.2%
6/13 • Number of events 8 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
41.2%
14/34 • Number of events 21 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
27.3%
3/11 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
53.6%
15/28 • Number of events 19 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
8.3%
1/12 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
43.8%
14/32 • Number of events 17 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
14.3%
1/7 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
35.3%
12/34 • Number of events 13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
26.7%
4/15 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
7.7%
1/13 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Skin and subcutaneous tissue disorders
ROSACEA
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/77 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
9.1%
1/11 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/32 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
|
Vascular disorders
HYPERTENSION
|
2.6%
2/77 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/78 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
1.3%
1/77 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
5.1%
4/78 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/78 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/13 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
2.9%
1/34 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/11 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/28 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/12 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
6.2%
2/32 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/7 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/34 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
0.00%
0/15 • Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), all-cause mortality (deaths) were collected from the first dose of study treatment (Day 1) up to the last dose of the study treatment (Day 337)+ 140 days safety follow-up for each participant, up to 477 days
Safety Analysis Part 1: Participants who received at least one dose of study treatment, including placebo, up to Week 24. Analysis based on SAF1 considered the treatment received, regardless of the assigned treatment according to randomization. Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least one dose of study treatment on or after Week 24. Analysis based on SAF2 considered the treatment at Week 24, regardless of treatment according to the re-randomization.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER