Trial Outcomes & Findings for A Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (PAH) (TROPOS Study). (NCT NCT05975905)
NCT ID: NCT05975905
Last Updated: 2026-07-02
Results Overview
Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background pulmonary arterial hypertension (PAH) therapy
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
113 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2026-07-02
Participant Flow
The study was conducted at 41 clinical study centers in Australia, Brazil, France, Germany, Poland, Portugal, Spain, Taiwan, South Korea, the United Kingdom, and the United States.
Participant milestones
| Measure |
Arm 4
Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B KER-012: Dose B KER-012 (Q4W);
Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks: Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W)
|
Arm 1
KER-012 (Dose A: 1.5 mg/kg) subcutaneously (SC) (every 4 weeks \[Q4W\]) Treatment Period: Dose A for 24 weeks; Extension Period: Dose A for another 72 weeks
Dose A: 1.5 mg/kg KER-012: Dose A KER-012 (Q4W);
|
Arm 2
KER-012 (Dose B: 3.0 mg/kg) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B: 3.0 mg/kg KER-012: Dose B KER-012 (Q4W);
|
Arm 3
KER-012 (Dose C: 4.5 mg/kg) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks
Dose C: 4.5 mg/kg KER-012: Dose C KER-012 (Q4W);
|
|---|---|---|---|---|
|
Treatment Period (24 Weeks)
STARTED
|
39
|
24
|
25
|
25
|
|
Treatment Period (24 Weeks)
COMPLETED
|
17
|
12
|
6
|
7
|
|
Treatment Period (24 Weeks)
NOT COMPLETED
|
22
|
12
|
19
|
18
|
|
Extension Period (Additional 72 Weeks)
STARTED
|
17
|
12
|
6
|
7
|
|
Extension Period (Additional 72 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Extension Period (Additional 72 Weeks)
NOT COMPLETED
|
17
|
12
|
6
|
7
|
Reasons for withdrawal
| Measure |
Arm 4
Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B KER-012: Dose B KER-012 (Q4W);
Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks: Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W)
|
Arm 1
KER-012 (Dose A: 1.5 mg/kg) subcutaneously (SC) (every 4 weeks \[Q4W\]) Treatment Period: Dose A for 24 weeks; Extension Period: Dose A for another 72 weeks
Dose A: 1.5 mg/kg KER-012: Dose A KER-012 (Q4W);
|
Arm 2
KER-012 (Dose B: 3.0 mg/kg) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B: 3.0 mg/kg KER-012: Dose B KER-012 (Q4W);
|
Arm 3
KER-012 (Dose C: 4.5 mg/kg) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks
Dose C: 4.5 mg/kg KER-012: Dose C KER-012 (Q4W);
|
|---|---|---|---|---|
|
Treatment Period (24 Weeks)
Disease progression or clinical worsening
|
1
|
1
|
0
|
1
|
|
Treatment Period (24 Weeks)
Adverse Event
|
2
|
2
|
4
|
5
|
|
Treatment Period (24 Weeks)
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Treatment Period (24 Weeks)
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Treatment Period (24 Weeks)
Sponsor request
|
18
|
9
|
14
|
12
|
|
Extension Period (Additional 72 Weeks)
Adverse Event
|
0
|
2
|
0
|
0
|
|
Extension Period (Additional 72 Weeks)
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Extension Period (Additional 72 Weeks)
Sponsor decision to terminate for safety reasons
|
17
|
9
|
6
|
7
|
Baseline Characteristics
A Study to Investigate the Safety and Efficacy of KER-012 in Combination With Background Therapy in Adult Participants With Pulmonary Arterial Hypertension (PAH) (TROPOS Study).
Baseline characteristics by cohort
| Measure |
Arm 1
n=24 Participants
KER-012 (Dose A: 1.5 mg/kg) subcutaneously (SC) (every 4 weeks \[Q4W\]) Treatment Period: Dose A for 24 weeks; Extension Period: Dose A for another 72 weeks
Dose A: 1.5 mg/kg KER-012: Dose A KER-012 (Q4W);
|
Arm 2
n=25 Participants
KER-012 (Dose B: 3.0 mg/kg) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B: 3.0 mg/kg KER-012: Dose B KER-012 (Q4W);
|
Arm 3
n=25 Participants
KER-012 (Dose C: 4.5 mg/kg) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks
Dose C: 4.5 mg/kg KER-012: Dose C KER-012 (Q4W);
|
Arm 4
n=39 Participants
Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B KER-012: Dose B KER-012 (Q4W);
Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks: Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W)
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
19 Participants
n=9 Participants
|
|
Age, Continuous
|
45.0 Years
STANDARD_DEVIATION 10.61 • n=20 Participants
|
47.2 Years
STANDARD_DEVIATION 16.13 • n=20 Participants
|
47.2 Years
STANDARD_DEVIATION 15.88 • n=40 Participants
|
44.6 Years
STANDARD_DEVIATION 14.36 • n=5 Participants
|
45.8 Years
STANDARD_DEVIATION 14.30 • n=9 Participants
|
|
Age, Customized
Median (Q1, Q3)
|
44.0 Years
n=20 Participants
|
48.0 Years
n=20 Participants
|
47.0 Years
n=40 Participants
|
44.0 Years
n=5 Participants
|
45.0 Years
n=9 Participants
|
|
Age, Customized
< 65 years
|
23 Participants
n=20 Participants
|
21 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
34 Participants
n=5 Participants
|
100 Participants
n=9 Participants
|
|
Age, Customized
65 to 74 years
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=9 Participants
|
|
Age, Customized
≥ 75 years
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
|
Sex/Gender, Customized
Male
|
7 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
30 Participants
n=9 Participants
|
|
Sex/Gender, Customized
Female
|
17 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
28 Participants
n=5 Participants
|
83 Participants
n=9 Participants
|
|
Sex/Gender, Customized
Female with childbearing potential
|
14 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
17 Participants
n=5 Participants
|
49 Participants
n=9 Participants
|
|
Sex/Gender, Customized
Female without childbearing potential
|
3 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
26 Participants
n=5 Participants
|
91 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
34 Participants
n=5 Participants
|
97 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=9 Participants
|
|
Height (cm)
|
163.0 cm
n=20 Participants
|
163.0 cm
n=20 Participants
|
167.0 cm
n=40 Participants
|
163.0 cm
n=5 Participants
|
164.0 cm
n=9 Participants
|
|
Weight (kg)
|
70.25 kg
n=20 Participants
|
63.50 kg
n=20 Participants
|
75.50 kg
n=40 Participants
|
70.00 kg
n=5 Participants
|
69.90 kg
n=9 Participants
|
|
BMI (kg/m2)
|
26.50 kg/m2
n=20 Participants
|
24.90 kg/m2
n=20 Participants
|
26.90 kg/m2
n=40 Participants
|
26.10 kg/m2
n=5 Participants
|
26.10 kg/m2
n=9 Participants
|
|
BMI (kg/m2)
< 18.5 (Underweight)
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=9 Participants
|
|
BMI (kg/m2)
≥ 18.5 to < 25 (Normal weight)
|
3 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
11 Participants
n=5 Participants
|
36 Participants
n=9 Participants
|
|
BMI (kg/m2)
≥ 25 to < 30 (Overweight)
|
14 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
16 Participants
n=5 Participants
|
42 Participants
n=9 Participants
|
|
BMI (kg/m2)
≥ 30 (Obesity Class I)
|
4 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
10 Participants
n=5 Participants
|
28 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Data were collected but the study was terminated before cleaning or analysis could occur. No verified summary statistics are available for reporting.
Evaluate the effect of KER-012 on pulmonary hemodynamics compared to Placebo in participants on background pulmonary arterial hypertension (PAH) therapy
Outcome measures
| Measure |
Arm 1
n=24 Participants
KER-012 (Dose A) subcutaneously (SC) (every 4 weeks \[Q4W\]) Treatment Period: Dose A for 24 weeks; Extension Period: Dose A for another 72 weeks
Dose A KER-012: Dose A KER-012 (Q4W);
|
Arm 2
n=25 Participants
KER-012 (Dose B) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B KER-012: Dose B KER-012 (Q4W);
|
Arm 3
n=25 Participants
KER-012 (Dose C) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks
Dose C KER-012: Dose C KER-012 (Q4W);
|
Arm 4
n=39 Participants
Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B KER-012: Dose B KER-012 (Q4W);
Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks: Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W)
|
|---|---|---|---|---|
|
Change From Baseline in PVR (Pulmonary Vascular Resistance)
|
-15.3 dyn*sec/cm^5
Interval -511.0 to 1809.0
|
-73.0 dyn*sec/cm^5
Interval -305.2 to 191.0
|
-81.0 dyn*sec/cm^5
Interval -325.0 to 42.6
|
-47.8 dyn*sec/cm^5
Interval -626.2 to 541.0
|
SECONDARY outcome
Timeframe: Through week 24 (primary treatment period)Population: Data were collected but the study was terminated before cleaning or analysis could occur. No verified summary statistics are available for reporting.
Evaluate the effect of KER-012 on exercise capacity compared to Placebo in participants on background PAH therapy
Outcome measures
| Measure |
Arm 1
n=24 Participants
KER-012 (Dose A) subcutaneously (SC) (every 4 weeks \[Q4W\]) Treatment Period: Dose A for 24 weeks; Extension Period: Dose A for another 72 weeks
Dose A KER-012: Dose A KER-012 (Q4W);
|
Arm 2
n=25 Participants
KER-012 (Dose B) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B KER-012: Dose B KER-012 (Q4W);
|
Arm 3
n=25 Participants
KER-012 (Dose C) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks
Dose C KER-012: Dose C KER-012 (Q4W);
|
Arm 4
n=39 Participants
Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B KER-012: Dose B KER-012 (Q4W);
Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks: Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W)
|
|---|---|---|---|---|
|
Change From Baseline in the 6MWD
|
13.3 Minutes
Interval -57.0 to 232.0
|
5.3 Minutes
Interval -271.5 to 88.5
|
-7.5 Minutes
Interval -53.5 to 74.5
|
3.0 Minutes
Interval -82.0 to 103.5
|
SECONDARY outcome
Timeframe: Up to week 24 (primary treatment period)Population: Data were collected but the study was terminated before cleaning or analysis could occur. No verified summary statistics are available for reporting.
Proportion of participants who achieved improvement from Baseline in NYHA FC/WHO at week 24. Improvement in WHO/NYHA FC (World Heath Association/New York Heart Association functional class) was defined as a decreased in functional class from baseline or maintenance of WHO/NYHA = 2 from baseline.
Outcome measures
| Measure |
Arm 1
n=24 Participants
KER-012 (Dose A) subcutaneously (SC) (every 4 weeks \[Q4W\]) Treatment Period: Dose A for 24 weeks; Extension Period: Dose A for another 72 weeks
Dose A KER-012: Dose A KER-012 (Q4W);
|
Arm 2
n=25 Participants
KER-012 (Dose B) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B KER-012: Dose B KER-012 (Q4W);
|
Arm 3
n=25 Participants
KER-012 (Dose C) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks
Dose C KER-012: Dose C KER-012 (Q4W);
|
Arm 4
n=39 Participants
Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B KER-012: Dose B KER-012 (Q4W);
Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks: Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W)
|
|---|---|---|---|---|
|
Evaluate Improvement in Functional Assessment of KER-012 Compared to Placebo in Participants on Background PAH Therapy
|
15 Participants
|
6 Participants
|
7 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to week 24 (primary treatment period)Population: Data were collected but the study was terminated before cleaning or analysis could occur. No verified summary statistics are available for reporting.
Change from Baseline in NT-proBNP at week 24
Outcome measures
| Measure |
Arm 1
n=24 Participants
KER-012 (Dose A) subcutaneously (SC) (every 4 weeks \[Q4W\]) Treatment Period: Dose A for 24 weeks; Extension Period: Dose A for another 72 weeks
Dose A KER-012: Dose A KER-012 (Q4W);
|
Arm 2
n=25 Participants
KER-012 (Dose B) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B KER-012: Dose B KER-012 (Q4W);
|
Arm 3
n=25 Participants
KER-012 (Dose C) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks
Dose C KER-012: Dose C KER-012 (Q4W);
|
Arm 4
n=39 Participants
Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B KER-012: Dose B KER-012 (Q4W);
Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks: Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W)
|
|---|---|---|---|---|
|
Evaluate the Changes From Baseline in the Concentration of the PAH Biomarker, NT-proBNP in Blood Samples
|
0.0 ng/L
Interval -981.0 to 262.0
|
-35.5 ng/L
Interval -482.0 to 88.0
|
-4.0 ng/L
Interval -148.0 to 544.0
|
-7.0 ng/L
Interval -562.0 to 736.0
|
Adverse Events
Arm 1
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Arm 2
Serious events: 3 serious events
Other events: 9 other events
Deaths: 1 deaths
Arm 3
Serious events: 9 serious events
Other events: 7 other events
Deaths: 1 deaths
Arm 4
Serious events: 5 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm 1
n=24 participants at risk
KER-012 (Dose A: 1.5 mg/kg) subcutaneously (SC) (every 4 weeks \[Q4W\]) Treatment Period: Dose A for 24 weeks; Extension Period: Dose A for another 72 weeks
Dose A: 1.5 mg/kg KER-012: Dose A KER-012 (Q4W);
|
Arm 2
n=25 participants at risk
KER-012 (Dose B: 3.0 mg/kg) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B: 3.0 mg/kg KER-012: Dose B KER-012 (Q4W);
|
Arm 3
n=25 participants at risk
KER-012 (Dose C: 4.5 mg/kg) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks
Dose C: 4.5 mg/kg KER-012: Dose C KER-012 (Q4W);
|
Arm 4
n=39 participants at risk
Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B KER-012: Dose B KER-012 (Q4W);
Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks: Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W). Please note that Arm 4 refers specifically to the blinded treatment phase
|
|---|---|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
4.2%
1/24 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
8.0%
2/25 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
12.0%
3/25 • Number of events 3 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
2.6%
1/39 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
2.6%
1/39 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
2.6%
1/39 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
12.0%
3/25 • Number of events 3 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
8.0%
2/25 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Infections and infestations
Cholecystitis infective
|
4.2%
1/24 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Infections and infestations
Haematological infection
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
2.6%
1/39 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Investigations
Body temperature increased
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Nervous system disorders
Syncope
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
2.6%
1/39 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
2.6%
1/39 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
Other adverse events
| Measure |
Arm 1
n=24 participants at risk
KER-012 (Dose A: 1.5 mg/kg) subcutaneously (SC) (every 4 weeks \[Q4W\]) Treatment Period: Dose A for 24 weeks; Extension Period: Dose A for another 72 weeks
Dose A: 1.5 mg/kg KER-012: Dose A KER-012 (Q4W);
|
Arm 2
n=25 participants at risk
KER-012 (Dose B: 3.0 mg/kg) SC (Q4W) Treatment Period: Dose B for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B: 3.0 mg/kg KER-012: Dose B KER-012 (Q4W);
|
Arm 3
n=25 participants at risk
KER-012 (Dose C: 4.5 mg/kg) SC (Q4W) Treatment Period: Dose C for 24 weeks; Extension Period: Dose C for another 72 weeks
Dose C: 4.5 mg/kg KER-012: Dose C KER-012 (Q4W);
|
Arm 4
n=39 participants at risk
Treatment Period: Placebo for 24 weeks; Extension Period: Dose B for another 72 weeks
Dose B KER-012: Dose B KER-012 (Q4W);
Placebo for 24 Weeks followed by Dose B KER-012 for 72 weeks: Treatment Period (24 weeks): Placebo SC (Q4W) Extension Period (72 weeks after Placebo treatment): KER-012 (Dose B) SC (Q4W). Please note that Arm 4 refers specifically to the blinded treatment phase
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
12.0%
3/25 • Number of events 3 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
2.6%
1/39 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
General disorders
Fatigue
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
General disorders
Injection site erythema
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
8.0%
2/25 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
24.0%
6/25 • Number of events 6 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
2.6%
1/39 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
General disorders
Injection site pain
|
20.8%
5/24 • Number of events 5 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
8.0%
2/25 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.2%
1/24 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
16.0%
4/25 • Number of events 4 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
2.6%
1/39 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
General disorders
Injection site reaction
|
8.3%
2/24 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
8.0%
2/25 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
12.0%
3/25 • Number of events 3 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
2.6%
1/39 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
General disorders
Injection site pruritus
|
8.3%
2/24 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
8.0%
2/25 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
5.1%
2/39 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.3%
2/24 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
8.0%
2/25 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
8.0%
2/25 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
General disorders
Dizziness
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
8.0%
2/25 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Infections and infestations
Influenza like illness
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
8.0%
2/25 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/39 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Infections and infestations
Nasopharyngitis
|
12.5%
3/24 • Number of events 3 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
8.0%
2/25 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
8.0%
2/25 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
2.6%
1/39 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
1/24 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
12.0%
3/25 • Number of events 3 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
2.6%
1/39 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
General disorders
Oedema peripheral
|
0.00%
0/24 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
4.0%
1/25 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
16.0%
4/25 • Number of events 4 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
2.6%
1/39 • Number of events 1 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.3%
2/24 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
8.0%
2/25 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
0.00%
0/25 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
5.1%
2/39 • Number of events 2 • From Baseline through the end of the Open-Label Extension/ date of termination of Open-Label Extension. Per protocol, 56 days (±5 days) after last dose of IMP, up to 72 weeks
Per the final Clinical Study Report, participants switching from Placebo to active treatment (Arm 4) were analyzed under the active dose received during the OLE to provide a comprehensive assessment of the intervention's safety profile rather than as a standalone cohort.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60