Trial Outcomes & Findings for A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it) (NCT NCT05574010)
NCT ID: NCT05574010
Last Updated: 2026-03-10
Results Overview
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. According to NCI CTCAE version 5: Grade 1= mild AE; Grade 2= moderate AE; Grade 3=severe AE; Grade 4= life-threatening consequences and urgent intervention indicated; Grade 5= death related to AE.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
128 participants
Primary outcome timeframe
From screening until the safety follow-up visit on Day 28
Results posted on
2026-03-10
Participant Flow
Safety Analysis Set includes all participants who received any portion of study intervention in Parts A, B and C. Participants were analyzed according to the intervention they actually received. In Part B, a total of 11 participants were assigned to the KAN-101 treatment groups, and only 10 received study intervention. In Part C, a total of 80 participants were assigned to the KAN-101 treatment groups, and only 79 received study intervention.
Participant milestones
| Measure |
Part A, Cohort 1 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part A, Cohort 2 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
3
|
3
|
5
|
27
|
26
|
26
|
28
|
|
Overall Study
COMPLETED
|
3
|
2
|
4
|
3
|
2
|
5
|
26
|
22
|
21
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
4
|
5
|
1
|
Reasons for withdrawal
| Measure |
Part A, Cohort 1 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part A, Cohort 2 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 0.6 mg/kg KAN-101
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
4
|
4
|
1
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in Celiac Disease (ACeD-it)
Baseline characteristics by cohort
| Measure |
Part A, Cohort 1 1.2 mg/kg KAN-101
n=3 Participants
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=4 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 1.2 mg/kg KAN-101
n=3 Participants
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
n=5 Participants
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 0.6 mg/kg KAN-101
n=27 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
n=26 Participants
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
n=26 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C Placebo
n=28 Participants
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.7 years
STANDARD_DEVIATION 23.03 • n=68 Participants
|
41.7 years
STANDARD_DEVIATION 18.77 • n=69 Participants
|
35.75 years
STANDARD_DEVIATION 9.54 • n=137 Participants
|
41.00 years
STANDARD_DEVIATION 15.72 • n=88 Participants
|
39.67 years
STANDARD_DEVIATION 12.66 • n=127 Participants
|
56.80 years
STANDARD_DEVIATION 11.88 • n=605 Participants
|
41.70 years
STANDARD_DEVIATION 15.19 • n=9 Participants
|
35.96 years
STANDARD_DEVIATION 15.61 • n=72 Participants
|
40.08 years
STANDARD_DEVIATION 16.14 • n=6 Participants
|
38.71 years
STANDARD_DEVIATION 14.02 • n=63 Participants
|
39.91 years
STANDARD_DEVIATION 15.21 • n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=68 Participants
|
3 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
1 Participants
n=88 Participants
|
3 Participants
n=127 Participants
|
3 Participants
n=605 Participants
|
21 Participants
n=9 Participants
|
16 Participants
n=72 Participants
|
19 Participants
n=6 Participants
|
25 Participants
n=63 Participants
|
94 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
3 Participants
n=137 Participants
|
2 Participants
n=88 Participants
|
0 Participants
n=127 Participants
|
2 Participants
n=605 Participants
|
6 Participants
n=9 Participants
|
10 Participants
n=72 Participants
|
7 Participants
n=6 Participants
|
3 Participants
n=63 Participants
|
34 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=605 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=68 Participants
|
3 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
3 Participants
n=88 Participants
|
3 Participants
n=127 Participants
|
5 Participants
n=605 Participants
|
26 Participants
n=9 Participants
|
25 Participants
n=72 Participants
|
26 Participants
n=6 Participants
|
28 Participants
n=63 Participants
|
126 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=605 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=72 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=63 Participants
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=68 Participants
|
3 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
3 Participants
n=88 Participants
|
3 Participants
n=127 Participants
|
5 Participants
n=605 Participants
|
26 Participants
n=9 Participants
|
26 Participants
n=72 Participants
|
25 Participants
n=6 Participants
|
28 Participants
n=63 Participants
|
126 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=605 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=63 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=605 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=72 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=63 Participants
|
1 Participants
n=10 Participants
|
|
Height
|
163.43 cm
STANDARD_DEVIATION 3.024 • n=68 Participants
|
165.73 cm
STANDARD_DEVIATION 3.573 • n=69 Participants
|
178.00 cm
STANDARD_DEVIATION 10.22 • n=137 Participants
|
171.53 cm
STANDARD_DEVIATION 2.41 • n=88 Participants
|
168.80 cm
STANDARD_DEVIATION 10.17 • n=127 Participants
|
167.26 cm
STANDARD_DEVIATION 8.33 • n=605 Participants
|
169.90 cm
STANDARD_DEVIATION 11.18 • n=9 Participants
|
169.85 cm
STANDARD_DEVIATION 10.59 • n=72 Participants
|
167.75 cm
STANDARD_DEVIATION 8.61 • n=6 Participants
|
167.15 cm
STANDARD_DEVIATION 8.29 • n=63 Participants
|
168.77 cm
STANDARD_DEVIATION 9.42 • n=10 Participants
|
|
Weight
|
62.00 kg
STANDARD_DEVIATION 11.345 • n=68 Participants
|
81.10 kg
STANDARD_DEVIATION 26.380 • n=69 Participants
|
85.53 kg
STANDARD_DEVIATION 30.60 • n=137 Participants
|
78.60 kg
STANDARD_DEVIATION 23.73 • n=88 Participants
|
78.73 kg
STANDARD_DEVIATION 15.29 • n=127 Participants
|
73.04 kg
STANDARD_DEVIATION 9.44 • n=605 Participants
|
80.71 kg
STANDARD_DEVIATION 19.01 • n=9 Participants
|
78.78 kg
STANDARD_DEVIATION 21.60 • n=72 Participants
|
78.35 kg
STANDARD_DEVIATION 19.94 • n=6 Participants
|
82.69 kg
STANDARD_DEVIATION 18.67 • n=63 Participants
|
79.60 kg
STANDARD_DEVIATION 19.54 • n=10 Participants
|
|
Body Mass Index
|
23.12 kg/m2
STANDARD_DEVIATION 3.489 • n=68 Participants
|
29.32 kg/m2
STANDARD_DEVIATION 8.498 • n=69 Participants
|
26.47 kg/m2
STANDARD_DEVIATION 6.95 • n=137 Participants
|
26.58 kg/m2
STANDARD_DEVIATION 7.36 • n=88 Participants
|
27.47 kg/m2
STANDARD_DEVIATION 3.48 • n=127 Participants
|
26.08 kg/m2
STANDARD_DEVIATION 2.64 • n=605 Participants
|
27.84 kg/m2
STANDARD_DEVIATION 5.61 • n=9 Participants
|
27.30 kg/m2
STANDARD_DEVIATION 7.08 • n=72 Participants
|
27.65 kg/m2
STANDARD_DEVIATION 5.49 • n=6 Participants
|
29.70 kg/m2
STANDARD_DEVIATION 7.09 • n=63 Participants
|
27.87 kg/m2
STANDARD_DEVIATION 6.19 • n=10 Participants
|
|
Time since First CeD Diagnosis
|
5.5 years
STANDARD_DEVIATION 2.76 • n=68 Participants
|
7.5 years
STANDARD_DEVIATION 7.69 • n=69 Participants
|
5.54 years
STANDARD_DEVIATION 5.61 • n=137 Participants
|
9.51 years
STANDARD_DEVIATION 4.80 • n=88 Participants
|
7.83 years
STANDARD_DEVIATION 6.24 • n=127 Participants
|
12.82 years
STANDARD_DEVIATION 5.02 • n=605 Participants
|
6.89 years
STANDARD_DEVIATION 5.64 • n=9 Participants
|
9.46 years
STANDARD_DEVIATION 7.61 • n=72 Participants
|
8.05 years
STANDARD_DEVIATION 5.74 • n=6 Participants
|
6.69 years
STANDARD_DEVIATION 4.87 • n=63 Participants
|
7.86 years
STANDARD_DEVIATION 5.95 • n=10 Participants
|
|
Time on GFD
|
5.5 years
STANDARD_DEVIATION 2.83 • n=68 Participants
|
6.9 years
STANDARD_DEVIATION 6.99 • n=69 Participants
|
5.31 years
STANDARD_DEVIATION 5.33 • n=137 Participants
|
9.39 years
STANDARD_DEVIATION 4.79 • n=88 Participants
|
7.22 years
STANDARD_DEVIATION 6.81 • n=127 Participants
|
7.88 years
STANDARD_DEVIATION 9.01 • n=605 Participants
|
6.26 years
STANDARD_DEVIATION 5.11 • n=9 Participants
|
9.15 years
STANDARD_DEVIATION 7.66 • n=72 Participants
|
6.90 years
STANDARD_DEVIATION 5.26 • n=6 Participants
|
6.44 years
STANDARD_DEVIATION 4.96 • n=63 Participants
|
7.14 years
STANDARD_DEVIATION 5.85 • n=10 Participants
|
|
Positive Celiac Serology at Diagnosis
TISSUE TRANSGLUTAMINASE IGA ANTIBODY (TTG-IGA)
|
3 Participants
n=68 Participants
|
3 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
3 Participants
n=88 Participants
|
2 Participants
n=127 Participants
|
3 Participants
n=605 Participants
|
24 Participants
n=9 Participants
|
26 Participants
n=72 Participants
|
25 Participants
n=6 Participants
|
26 Participants
n=63 Participants
|
119 Participants
n=10 Participants
|
|
Positive Celiac Serology at Diagnosis
TISSUE TRANSGLUTAMINASE IGG ANTIBODY (TTG-IGG)
|
2 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
2 Participants
n=127 Participants
|
1 Participants
n=605 Participants
|
4 Participants
n=9 Participants
|
3 Participants
n=72 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=63 Participants
|
21 Participants
n=10 Participants
|
|
Positive Celiac Serology at Diagnosis
DEAMIDATED GLIADIN PEPTIDE IGA (DGP-IGA)
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
1 Participants
n=88 Participants
|
0 Participants
n=127 Participants
|
1 Participants
n=605 Participants
|
6 Participants
n=9 Participants
|
5 Participants
n=72 Participants
|
10 Participants
n=6 Participants
|
2 Participants
n=63 Participants
|
25 Participants
n=10 Participants
|
|
Positive Celiac Serology at Diagnosis
DEAMIDATED GLIADIN PEPTIDE IGG (DGP-IGG)
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
1 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=127 Participants
|
1 Participants
n=605 Participants
|
5 Participants
n=9 Participants
|
5 Participants
n=72 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=63 Participants
|
22 Participants
n=10 Participants
|
|
Positive Histology at Diagnosis
EVIDENCE OF VILLOUS ATROPHY (NO MARSH SCORE REPORTED)
|
2 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
4 Participants
n=137 Participants
|
3 Participants
n=88 Participants
|
2 Participants
n=127 Participants
|
4 Participants
n=605 Participants
|
18 Participants
n=9 Participants
|
19 Participants
n=72 Participants
|
15 Participants
n=6 Participants
|
21 Participants
n=63 Participants
|
89 Participants
n=10 Participants
|
|
Positive Histology at Diagnosis
MARSH SCORE 2
|
1 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=605 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=72 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=63 Participants
|
4 Participants
n=10 Participants
|
|
Positive Histology at Diagnosis
MARSH SCORE 3A
|
0 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=605 Participants
|
3 Participants
n=9 Participants
|
2 Participants
n=72 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=63 Participants
|
13 Participants
n=10 Participants
|
|
Positive Histology at Diagnosis
MARSH SCORE 3B
|
0 Participants
n=68 Participants
|
1 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
1 Participants
n=127 Participants
|
0 Participants
n=605 Participants
|
4 Participants
n=9 Participants
|
3 Participants
n=72 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=63 Participants
|
11 Participants
n=10 Participants
|
|
Positive Histology at Diagnosis
MARSH SCORE 3C
|
0 Participants
n=68 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=137 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=127 Participants
|
1 Participants
n=605 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=72 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=63 Participants
|
11 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From screening until the safety follow-up visit on Day 28An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. According to NCI CTCAE version 5: Grade 1= mild AE; Grade 2= moderate AE; Grade 3=severe AE; Grade 4= life-threatening consequences and urgent intervention indicated; Grade 5= death related to AE.
Outcome measures
| Measure |
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=3 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|
|
Incidence and Severity of TEAEs as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) in Part A
TEAE
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Incidence and Severity of TEAEs as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) in Part A
SAE
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Incidence and Severity of TEAEs as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) in Part A
Grade 2 TEAE
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Incidence and Severity of TEAEs as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) in Part A
Grade 3 or 4 TEAE
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Incidence and Severity of TEAEs as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) in Part A
Grade 5 TEAE
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Baseline screening to Day 15Population: Full analysis set - All participants who were randomly assigned to study intervention and received any portion of study intervention in Part B. Participants were analyzed according to the intervention they were randomized.
CeD increases the circulating level of IL-2. Plasma samples were collected to assess the magnitude of biomarker response of IL-2 at the baseline screening visit pre-GC and again post-GC on Day 15 after 3 doses of KAN-101, the IL-2 response to GC is the difference of IL-2 between pre-GC and post-GC.
Outcome measures
| Measure |
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=2 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
n=2 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
n=5 Participants
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|
|
Change in Pre- and Post-Gluten Challenge (GC) IL-2 Response From Baseline to Day 15
|
25.3 international unit
Standard Deviation 26.31
|
-2.3 international unit
Standard Deviation 7.80
|
-1.9 international unit
Standard Deviation 5.09
|
146.2 international unit
Standard Deviation 380.81
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (pre-GC) and 4 hours post-GC on Day 15Population: Full Analysis set - All participants who were randomly assigned to study intervention and received any portion of study intervention in Part C. Participants were analyzed according to the intervention they were randomized.
CeD increases the circulating level of IL-2. Plasma samples were collected to assess the magnitude of biomarker response of IL-2 at the baseline screening visit pre-GC and again post-GC on Day 15 after 3 doses of KAN-101, the IL-2 response to GC is the difference of IL-2 between pre-GC and post-GC.
Outcome measures
| Measure |
Part A, Cohort 2 3.0 mg/kg KAN-101
n=21 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=22 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
n=20 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
n=24 Participants
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|
|
Change in IL-2 Response From Day 15 Pre-GC to Day 15 Post GC
|
6.5 international unit
Standard Deviation 10.3
|
13.2 international unit
Standard Deviation 31.7
|
10.5 international unit
Standard Deviation 19.7
|
119.1 international unit
Standard Deviation 402.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7Population: PK Analysis Set - All participants who receive any portion of study intervention and have at least one concentration value in Part A.
PK sample collection at pre- dose and post dose timepoints in Part A.
Outcome measures
| Measure |
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=2 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|
|
KAN-101 Plasma Exposure in Part A: AUCinf
Day 1
|
29833.3 ng.hr/ml
Standard Deviation 6986.65
|
7585.0 ng.hr/ml
Standard Deviation 2227.39
|
—
|
—
|
—
|
—
|
|
KAN-101 Plasma Exposure in Part A: AUCinf
Day 7
|
27600.0 ng.hr/ml
Standard Deviation 5656.85
|
5025.0 ng.hr/ml
Standard Deviation 1152.58
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7Population: PK analysis set included all participants who received any portion of study intervention and had at least one concentration value in Part A.
PK sample collection at pre- dose and post dose timepoints in Part A.
Outcome measures
| Measure |
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=3 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|
|
KAN-101 Plasma Exposure in Part A: AUClast
Day 1
|
29633.3 ng.hr/mL
Standard Deviation 6940.70
|
6413.3 ng.hr/mL
Standard Deviation 2486.85
|
—
|
—
|
—
|
—
|
|
KAN-101 Plasma Exposure in Part A: AUClast
Day 7
|
27600.0 ng.hr/mL
Standard Deviation 5656.85
|
4770.0 ng.hr/mL
Standard Deviation 918.86
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7Population: PK analysis set included all participants who received any portion of study intervention and had at least one concentration value in Part A.
PK sample collection at pre- dose and post dose timepoints in Part A.
Outcome measures
| Measure |
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=3 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|
|
KAN-101 Plasma Exposure in Part A: Cmax
Day 1
|
27333.3 ng/mL
Standard Deviation 8788.82
|
8200.0 ng/mL
Standard Deviation 2317.67
|
—
|
—
|
—
|
—
|
|
KAN-101 Plasma Exposure in Part A: Cmax
Day 7
|
25900.0 ng/mL
Standard Deviation 4808.33
|
6083.3 ng/mL
Standard Deviation 2654.62
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7Population: PK analysis set included all participants who received any portion of study intervention and had at least one concentration value in Part A.
PK sample collection at pre- dose and post dose timepoints in Part A.
Outcome measures
| Measure |
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=3 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|
|
KAN-101 Plasma Exposure in Part A: Tmax
Day 1
|
0.6 hr
Standard Deviation 0.03
|
0.6 hr
Standard Deviation 0.01
|
—
|
—
|
—
|
—
|
|
KAN-101 Plasma Exposure in Part A: Tmax
Day 7
|
0.6 hr
Standard Deviation 0.05
|
0.6 hr
Standard Deviation 0.03
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, end of infusion, 45 minutes, 1 hour, 1.5 hour, 2.5 hours, 4.5 hours and 7 hours after infusion start on Day 1 and Day 7Population: PK Analysis Set - All participants who received any portion of study intervention and had at least 1 concentration value in Part A.
PK sample collection at pre- dose and post dose timepoints in Part A.
Outcome measures
| Measure |
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=2 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|
|
KAN-101 Plasma Exposure in Part A: t½
Day 1
|
0.4 hr
Standard Deviation 0.01
|
0.3 hr
Standard Deviation 0.06
|
—
|
—
|
—
|
—
|
|
KAN-101 Plasma Exposure in Part A: t½
Day 7
|
0.3 hr
Standard Deviation 0.00
|
0.2 hr
Standard Deviation 0.09
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7Population: PK analysis set included all participants who received any portion of study intervention and had at least one concentration value in Part B and C.
PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
Outcome measures
| Measure |
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=4 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
n=27 Participants
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
n=26 Participants
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
n=26 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|
|
KAN-101 Plasma Exposure in Part B and Part C: AUCinf
|
NA ng.hr/mL
Area-under the curve could not be calculated due to majority of samples being below the level of detection
|
NA ng.hr/mL
Area-under the curve could not be calculated due to majority of samples being below the level of detection
|
NA ng.hr/mL
Area-under the curve could not be calculated due to majority of samples being below the level of detection
|
NA ng.hr/mL
Area-under the curve could not be calculated due to majority of samples being below the level of detection
|
NA ng.hr/mL
Area-under the curve could not be calculated due to majority of samples being below the level of detection
|
NA ng.hr/mL
Area-under the curve could not be calculated due to majority of samples being below the level of detection
|
SECONDARY outcome
Timeframe: Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7Population: PK analysis set included all participants who received any portion of study intervention and had at least one concentration value in Part B and C. Due to the short half-life of KAN-101, for majority of the samples in Parts B and C, the terminal elimination phase was measured as 'below level of detection'. Results of AUClast which are shown as N/A are due to the majority of samples being below level of quantification.
PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
Outcome measures
| Measure |
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=4 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
n=27 Participants
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
n=26 Participants
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
n=26 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|
|
KAN-101 Plasma Exposure in Part B and Part C: AUClast
Day 1
|
NA ng.hr/mL
Area-under the curve could not be calculated due to majority of samples being below the level of detection
|
NA ng.hr/mL
Area-under the curve could not be calculated due to majority of samples being below the level of detection
|
19700.0 ng.hr/mL
Standard Deviation 10748.0
|
NA ng.hr/mL
Area-under the curve could not be calculated due to majority of samples being below the level of detection
|
NA ng.hr/mL
Area-under the curve could not be calculated due to majority of samples being below the level of detection
|
29607.1 ng.hr/mL
Standard Deviation 6854.58
|
|
KAN-101 Plasma Exposure in Part B and Part C: AUClast
Day 7
|
NA ng.hr/mL
Area-under the curve could not be calculated due to majority of samples being below the level of detection
|
NA ng.hr/mL
Area-under the curve could not be calculated due to majority of samples being below the level of detection
|
26600.0 ng.hr/mL
SD could not be calculated due to only a single participant contributing data to the time point
|
6930.0 ng.hr/mL
SD could not be calculated due to only a single participant contributing data to the time point
|
5380.0 ng.hr/mL
SD could not be calculated due to only a single participant contributing data to the time point
|
29808.3 ng.hr/mL
Standard Deviation 7079.74
|
SECONDARY outcome
Timeframe: Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7Population: PK analysis set included all participants who received any portion of study intervention and had at least one concentration value in Part B and C.
PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
Outcome measures
| Measure |
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=4 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
n=27 Participants
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
n=26 Participants
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
n=26 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|
|
KAN-101 Plasma Exposure in Part B and Part C: Cmax
Day 1
|
12263.3 ng/mL
Standard Deviation 7755.90
|
3707.5 ng/mL
Standard Deviation 760.59
|
20166.7 ng/mL
Standard Deviation 8903.00
|
4208.8 ng/mL
Standard Deviation 1761.10
|
10099.5 ng/mL
Standard Deviation 2696.17
|
30243.2 ng/mL
Standard Deviation 6909.18
|
|
KAN-101 Plasma Exposure in Part B and Part C: Cmax
Day 7
|
8536.7 ng/mL
Standard Deviation 3174.59
|
2805.0 ng/mL
Standard Deviation 1001.48
|
24450.0 ng/mL
Standard Deviation 9404.52
|
5016.8 ng/mL
Standard Deviation 1314.39
|
8906.3 ng/mL
Standard Deviation 2456.73
|
30816.7 ng/mL
Standard Deviation 7084.88
|
SECONDARY outcome
Timeframe: Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7Population: PK analysis set included all participants who received any portion of study intervention and had at least one concentration value in Part B and C.
PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
Outcome measures
| Measure |
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=4 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
n=27 Participants
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
n=26 Participants
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
n=26 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|
|
KAN-101 Plasma Exposure in Part B and Part C: Tmax
Day 7
|
0.6 hr
Standard Deviation 0.04
|
0.6 hr
Standard Deviation 0.04
|
0.5 hr
Standard Deviation 0.01
|
0.5 hr
Standard Deviation 0.05
|
0.6 hr
Standard Deviation 0.22
|
0.5 hr
Standard Deviation 0.06
|
|
KAN-101 Plasma Exposure in Part B and Part C: Tmax
Day 1
|
0.6 hr
Standard Deviation 0.01
|
0.5 hr
Standard Deviation 0.01
|
0.5 hr
Standard Deviation 0.03
|
0.6 hr
Standard Deviation 0.09
|
0.5 hr
Standard Deviation 0.13
|
0.6 hr
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Pre-dose, end of infusion, 2.5 hours, and 4 hours after infusion start on Day 1 and Day 7PK sample collection at pre- dose and post dose timepoints in Part B and Part C.
Outcome measures
| Measure |
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=4 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
n=27 Participants
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
n=26 Participants
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
n=26 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|
|
KAN-101 Plasma Exposure in Part B and Part C: t½
|
NA hr
Due to insufficient sampling in the terminal elimination phase, t1/2 was not calculated
|
NA hr
Due to insufficient sampling in the terminal elimination phase, t1/2 was not calculated
|
NA hr
Due to insufficient sampling in the terminal elimination phase, t1/2 was not calculated
|
NA hr
Due to insufficient sampling in the terminal elimination phase, t1/2 was not calculated
|
NA hr
Due to insufficient sampling in the terminal elimination phase, t1/2 was not calculated
|
NA hr
Due to insufficient sampling in the terminal elimination phase, t1/2 was not calculated
|
SECONDARY outcome
Timeframe: From the time the participant provided informed consent through Week 52An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. According to NCI CTCAE version 5: Grade 1= mild AE; Grade 2= moderate AE; Grade 3=severe AE; Grade 4= life-threatening consequences and urgent intervention indicated; Grade 5= death related to AE.
Outcome measures
| Measure |
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=4 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
n=3 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
n=5 Participants
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|
|
Incidence and Severity of TEAE as Assessed by the CTCAE in Part B
TEAE
|
3 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
|
Incidence and Severity of TEAE as Assessed by the CTCAE in Part B
SAE
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Incidence and Severity of TEAE as Assessed by the CTCAE in Part B
Grade 2 TEAE
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Incidence and Severity of TEAE as Assessed by the CTCAE in Part B
Grade 3 or higher TEAE
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From the time the participant provided informed consent through Week 52An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events. SAE was defined as any untoward medical occurrence that, at any dose resulted in any of the following outcomes: death; life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event. According to NCI CTCAE version 5: Grade 1= mild AE; Grade 2= moderate AE; Grade 3=severe AE; Grade 4= life-threatening consequences and urgent intervention indicated; Grade 5= death related to AE.
Outcome measures
| Measure |
Part A, Cohort 2 3.0 mg/kg KAN-101
n=26 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=27 Participants
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
n=26 Participants
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
n=28 Participants
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|
|
Incidence and Severity of TEAE as Assessed by the CTCAE in Part C
TEAE
|
24 Participants
|
24 Participants
|
25 Participants
|
26 Participants
|
—
|
—
|
|
Incidence and Severity of TEAE as Assessed by the CTCAE in Part C
SAE
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Incidence and Severity of TEAE as Assessed by the CTCAE in Part C
Grade 2 TEAE
|
13 Participants
|
16 Participants
|
13 Participants
|
13 Participants
|
—
|
—
|
|
Incidence and Severity of TEAE as Assessed by the CTCAE in Part C
Grade 3 or higher TEAE
|
1 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
Adverse Events
Part A, Cohort 1 1.2 mg/kg KAN-101
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A, Cohort 2 3.0 mg/kg KAN-101
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B 0.6 mg/kg KAN-101
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B 1.2 mg/kg KAN-101
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B 3.0 mg/kg KAN-101
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part C 0.6 mg/kg KAN-101
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Part C 1.2 mg/kg KAN-101
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Part C 3.0 mg/kg KAN-101
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Part C Placebo
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A, Cohort 1 1.2 mg/kg KAN-101
n=3 participants at risk
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 participants at risk
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=4 participants at risk
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 1.2 mg/kg KAN-101
n=3 participants at risk
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
n=3 participants at risk
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
n=5 participants at risk
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 0.6 mg/kg KAN-101
n=27 participants at risk
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
n=26 participants at risk
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
n=26 participants at risk
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C Placebo
n=28 participants at risk
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Immune system disorders
Infusion related hypersensitivity reaction
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Renal and urinary disorders
Bladder perforation
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
Other adverse events
| Measure |
Part A, Cohort 1 1.2 mg/kg KAN-101
n=3 participants at risk
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part A, Cohort 2 3.0 mg/kg KAN-101
n=3 participants at risk
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions Day 1, Day 4 and Day 7
|
Part B 0.6 mg/kg KAN-101
n=4 participants at risk
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 1.2 mg/kg KAN-101
n=3 participants at risk
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B 3.0 mg/kg KAN-101
n=3 participants at risk
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part B Placebo
n=5 participants at risk
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 0.6 mg/kg KAN-101
n=27 participants at risk
All enrolled participants received 0.6 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 1.2 mg/kg KAN-101
n=26 participants at risk
All enrolled participants received 1.2 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C 3.0 mg/kg KAN-101
n=26 participants at risk
All enrolled participants received 3.0 mg/kg of KAN-101 via intravenous (IV) infusions every 3 days starting on Day 1
|
Part C Placebo
n=28 participants at risk
All enrolled participants received placebo via intravenous (IV) infusions every 3 days starting on Day 1
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Ear and labyrinth disorders
Ear pain
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
General disorders
Fatigue
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
75.0%
3/4 • From screening until the safety follow-up visit on Week 52.
|
66.7%
2/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
20.0%
1/5 • From screening until the safety follow-up visit on Week 52.
|
40.7%
11/27 • From screening until the safety follow-up visit on Week 52.
|
34.6%
9/26 • From screening until the safety follow-up visit on Week 52.
|
26.9%
7/26 • From screening until the safety follow-up visit on Week 52.
|
32.1%
9/28 • From screening until the safety follow-up visit on Week 52.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
50.0%
2/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Infections and infestations
COVID-19
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
20.0%
1/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
3.7%
1/27 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
11.5%
3/26 • From screening until the safety follow-up visit on Week 52.
|
7.1%
2/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
20.0%
1/5 • From screening until the safety follow-up visit on Week 52.
|
7.4%
2/27 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
15.4%
4/26 • From screening until the safety follow-up visit on Week 52.
|
7.1%
2/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
20.0%
1/5 • From screening until the safety follow-up visit on Week 52.
|
3.7%
1/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
7.1%
2/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Nervous system disorders
Brain fog
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
7.4%
2/27 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
15.4%
4/26 • From screening until the safety follow-up visit on Week 52.
|
14.3%
4/28 • From screening until the safety follow-up visit on Week 52.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
14.8%
4/27 • From screening until the safety follow-up visit on Week 52.
|
11.5%
3/26 • From screening until the safety follow-up visit on Week 52.
|
15.4%
4/26 • From screening until the safety follow-up visit on Week 52.
|
14.3%
4/28 • From screening until the safety follow-up visit on Week 52.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
20.0%
1/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
7.4%
2/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
3.6%
1/28 • From screening until the safety follow-up visit on Week 52.
|
|
General disorders
Chills
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
50.0%
2/4 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
7.4%
2/27 • From screening until the safety follow-up visit on Week 52.
|
11.5%
3/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
General disorders
Pain
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
20.0%
1/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
General disorders
Feeling cold
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
General disorders
Malaise
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
11.1%
3/27 • From screening until the safety follow-up visit on Week 52.
|
7.7%
2/26 • From screening until the safety follow-up visit on Week 52.
|
11.5%
3/26 • From screening until the safety follow-up visit on Week 52.
|
10.7%
3/28 • From screening until the safety follow-up visit on Week 52.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
20.0%
1/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
11.1%
3/27 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
7.7%
2/26 • From screening until the safety follow-up visit on Week 52.
|
3.6%
1/28 • From screening until the safety follow-up visit on Week 52.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
50.0%
2/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
20.0%
1/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
7.7%
2/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
7.4%
2/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
20.0%
1/5 • From screening until the safety follow-up visit on Week 52.
|
7.4%
2/27 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
3.7%
1/27 • From screening until the safety follow-up visit on Week 52.
|
7.7%
2/26 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
29.6%
8/27 • From screening until the safety follow-up visit on Week 52.
|
23.1%
6/26 • From screening until the safety follow-up visit on Week 52.
|
15.4%
4/26 • From screening until the safety follow-up visit on Week 52.
|
17.9%
5/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
40.0%
2/5 • From screening until the safety follow-up visit on Week 52.
|
33.3%
9/27 • From screening until the safety follow-up visit on Week 52.
|
23.1%
6/26 • From screening until the safety follow-up visit on Week 52.
|
38.5%
10/26 • From screening until the safety follow-up visit on Week 52.
|
21.4%
6/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
11.1%
3/27 • From screening until the safety follow-up visit on Week 52.
|
19.2%
5/26 • From screening until the safety follow-up visit on Week 52.
|
15.4%
4/26 • From screening until the safety follow-up visit on Week 52.
|
14.3%
4/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
66.7%
2/3 • From screening until the safety follow-up visit on Week 52.
|
50.0%
2/4 • From screening until the safety follow-up visit on Week 52.
|
66.7%
2/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
60.0%
3/5 • From screening until the safety follow-up visit on Week 52.
|
25.9%
7/27 • From screening until the safety follow-up visit on Week 52.
|
34.6%
9/26 • From screening until the safety follow-up visit on Week 52.
|
46.2%
12/26 • From screening until the safety follow-up visit on Week 52.
|
25.0%
7/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
7.4%
2/27 • From screening until the safety follow-up visit on Week 52.
|
7.7%
2/26 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
3.6%
1/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
100.0%
3/3 • From screening until the safety follow-up visit on Week 52.
|
100.0%
4/4 • From screening until the safety follow-up visit on Week 52.
|
66.7%
2/3 • From screening until the safety follow-up visit on Week 52.
|
100.0%
3/3 • From screening until the safety follow-up visit on Week 52.
|
80.0%
4/5 • From screening until the safety follow-up visit on Week 52.
|
51.9%
14/27 • From screening until the safety follow-up visit on Week 52.
|
57.7%
15/26 • From screening until the safety follow-up visit on Week 52.
|
69.2%
18/26 • From screening until the safety follow-up visit on Week 52.
|
60.7%
17/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
100.0%
4/4 • From screening until the safety follow-up visit on Week 52.
|
100.0%
3/3 • From screening until the safety follow-up visit on Week 52.
|
100.0%
3/3 • From screening until the safety follow-up visit on Week 52.
|
40.0%
2/5 • From screening until the safety follow-up visit on Week 52.
|
22.2%
6/27 • From screening until the safety follow-up visit on Week 52.
|
23.1%
6/26 • From screening until the safety follow-up visit on Week 52.
|
42.3%
11/26 • From screening until the safety follow-up visit on Week 52.
|
35.7%
10/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
100.0%
4/4 • From screening until the safety follow-up visit on Week 52.
|
100.0%
3/3 • From screening until the safety follow-up visit on Week 52.
|
66.7%
2/3 • From screening until the safety follow-up visit on Week 52.
|
20.0%
1/5 • From screening until the safety follow-up visit on Week 52.
|
37.0%
10/27 • From screening until the safety follow-up visit on Week 52.
|
34.6%
9/26 • From screening until the safety follow-up visit on Week 52.
|
42.3%
11/26 • From screening until the safety follow-up visit on Week 52.
|
10.7%
3/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
50.0%
2/4 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
66.7%
2/3 • From screening until the safety follow-up visit on Week 52.
|
40.0%
2/5 • From screening until the safety follow-up visit on Week 52.
|
37.0%
10/27 • From screening until the safety follow-up visit on Week 52.
|
42.3%
11/26 • From screening until the safety follow-up visit on Week 52.
|
34.6%
9/26 • From screening until the safety follow-up visit on Week 52.
|
46.4%
13/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
7.4%
2/27 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
3.6%
1/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
20.0%
1/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
7.4%
2/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
20.0%
1/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
20.0%
1/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
33.3%
1/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
25.0%
1/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
20.0%
1/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
11.1%
3/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
3.7%
1/27 • From screening until the safety follow-up visit on Week 52.
|
11.5%
3/26 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
7.1%
2/28 • From screening until the safety follow-up visit on Week 52.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
7.4%
2/27 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/28 • From screening until the safety follow-up visit on Week 52.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
7.1%
2/28 • From screening until the safety follow-up visit on Week 52.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/27 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
7.1%
2/28 • From screening until the safety follow-up visit on Week 52.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
3.7%
1/27 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
7.1%
2/28 • From screening until the safety follow-up visit on Week 52.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/4 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/3 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/5 • From screening until the safety follow-up visit on Week 52.
|
3.7%
1/27 • From screening until the safety follow-up visit on Week 52.
|
3.8%
1/26 • From screening until the safety follow-up visit on Week 52.
|
0.00%
0/26 • From screening until the safety follow-up visit on Week 52.
|
7.1%
2/28 • From screening until the safety follow-up visit on Week 52.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER