Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Hidradenitis Suppurativa (NCT NCT04856930)
NCT ID: NCT04856930
Last Updated: 2025-09-22
Results Overview
The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
149 participants
Primary outcome timeframe
Baseline, Week 16
Results posted on
2025-09-22
Participant Flow
Participants who had a clinically confirmed diagnosis of hidradenitis suppurativa (HS) with a disease duration of at least 6 months before Day 1, were enrolled in the study. Randomization was stratified based on Hurley Stage at Baseline (Stage II or III).
227 participants were screened for eligibility and 149 participants were randomized into the study.
Participant milestones
| Measure |
Imsidolimab 400/200 mg
Placebo-controlled period: Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous (SC) injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
|
Imsidolimab 200/100 mg
Placebo-controlled period: Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
|
Placebo
Placebo-controlled period: Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
|
|---|---|---|---|
|
Placebo-controlled Period (16 Weeks)
STARTED
|
50
|
50
|
49
|
|
Placebo-controlled Period (16 Weeks)
COMPLETED
|
41
|
42
|
43
|
|
Placebo-controlled Period (16 Weeks)
NOT COMPLETED
|
9
|
8
|
6
|
|
Extension Period (16 Weeks)
STARTED
|
41
|
42
|
43
|
|
Extension Period (16 Weeks)
COMPLETED
|
28
|
32
|
35
|
|
Extension Period (16 Weeks)
NOT COMPLETED
|
13
|
10
|
8
|
|
Follow-up Period (8 Weeks)
STARTED
|
28
|
32
|
35
|
|
Follow-up Period (8 Weeks)
COMPLETED
|
13
|
18
|
13
|
|
Follow-up Period (8 Weeks)
NOT COMPLETED
|
15
|
14
|
22
|
Reasons for withdrawal
| Measure |
Imsidolimab 400/200 mg
Placebo-controlled period: Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous (SC) injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
|
Imsidolimab 200/100 mg
Placebo-controlled period: Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
|
Placebo
Placebo-controlled period: Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
|
|---|---|---|---|
|
Placebo-controlled Period (16 Weeks)
Withdrawal by Subject
|
6
|
5
|
4
|
|
Placebo-controlled Period (16 Weeks)
Lost to Follow-up
|
3
|
1
|
0
|
|
Placebo-controlled Period (16 Weeks)
Pregnancy
|
0
|
1
|
0
|
|
Placebo-controlled Period (16 Weeks)
Protocol Violation
|
0
|
0
|
1
|
|
Placebo-controlled Period (16 Weeks)
Adverse Event
|
0
|
0
|
1
|
|
Placebo-controlled Period (16 Weeks)
Use of Any Prohibited Medication or Treatment
|
0
|
1
|
0
|
|
Extension Period (16 Weeks)
Withdrawal by Subject
|
9
|
5
|
1
|
|
Extension Period (16 Weeks)
Lost to Follow-up
|
2
|
5
|
1
|
|
Extension Period (16 Weeks)
Adverse Event
|
1
|
0
|
1
|
|
Extension Period (16 Weeks)
Pregnancy
|
0
|
0
|
2
|
|
Extension Period (16 Weeks)
Use of Any Prohibited Medication or Treatment
|
1
|
0
|
0
|
|
Extension Period (16 Weeks)
Stopped participation by Sponsor
|
0
|
0
|
2
|
|
Extension Period (16 Weeks)
Other than specified
|
0
|
0
|
1
|
|
Follow-up Period (8 Weeks)
Withdrawal by Subject
|
3
|
2
|
3
|
|
Follow-up Period (8 Weeks)
Lost to Follow-up
|
0
|
0
|
1
|
|
Follow-up Period (8 Weeks)
Adverse Event
|
0
|
0
|
1
|
|
Follow-up Period (8 Weeks)
Stopped participation by Sponsor
|
12
|
12
|
17
|
Baseline Characteristics
ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline.
Baseline characteristics by cohort
| Measure |
Imsidolimab 400/200 mg
n=50 Participants
Placebo-controlled period: Participants received a starting dose of 400 milligrams (mg) of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by subcutaneous (SC) injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
|
Imsidolimab 200/100 mg
n=50 Participants
Placebo-controlled period: Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
|
Placebo
n=49 Participants
Placebo-controlled period: Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection. The placebo-controlled period ended at Day 113 (Week 16).
Extension period: Participants received imsidolimab at the same dose as placebo-controlled period, SC every 4 weeks (Days 113, 141, 169, and 197).
After discontinuation from treatment, participants remained in the study for safety follow-up period of 8 weeks.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.2 years
STANDARD_DEVIATION 11.35 • n=50 Participants
|
36.0 years
STANDARD_DEVIATION 12.20 • n=50 Participants
|
36.8 years
STANDARD_DEVIATION 11.56 • n=49 Participants
|
35.7 years
STANDARD_DEVIATION 11.68 • n=149 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=50 Participants
|
37 Participants
n=50 Participants
|
28 Participants
n=49 Participants
|
96 Participants
n=149 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=50 Participants
|
13 Participants
n=50 Participants
|
21 Participants
n=49 Participants
|
53 Participants
n=149 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=50 Participants
|
9 Participants
n=50 Participants
|
6 Participants
n=49 Participants
|
22 Participants
n=149 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=50 Participants
|
41 Participants
n=50 Participants
|
43 Participants
n=49 Participants
|
127 Participants
n=149 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=149 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=50 Participants
|
1 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
1 Participants
n=149 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=50 Participants
|
3 Participants
n=50 Participants
|
1 Participants
n=49 Participants
|
5 Participants
n=149 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=149 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=50 Participants
|
7 Participants
n=50 Participants
|
10 Participants
n=49 Participants
|
29 Participants
n=149 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=50 Participants
|
37 Participants
n=50 Participants
|
37 Participants
n=49 Participants
|
110 Participants
n=149 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
1 Participants
n=49 Participants
|
4 Participants
n=149 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=49 Participants
|
0 Participants
n=149 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=50 Participants
|
4 participants
n=50 Participants
|
6 participants
n=49 Participants
|
15 participants
n=149 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=50 Participants
|
29 participants
n=50 Participants
|
30 participants
n=49 Participants
|
88 participants
n=149 Participants
|
|
Region of Enrollment
Poland
|
11 participants
n=50 Participants
|
15 participants
n=50 Participants
|
13 participants
n=49 Participants
|
39 participants
n=149 Participants
|
|
Region of Enrollment
Georgia
|
5 participants
n=50 Participants
|
2 participants
n=50 Participants
|
0 participants
n=49 Participants
|
7 participants
n=149 Participants
|
|
Abscess and Inflammatory Nodule (AN) Count
|
14.0 count of abscess and inflammatory nodule
STANDARD_DEVIATION 9.87 • n=50 Participants
|
11.9 count of abscess and inflammatory nodule
STANDARD_DEVIATION 9.79 • n=50 Participants
|
12.1 count of abscess and inflammatory nodule
STANDARD_DEVIATION 8.31 • n=49 Participants
|
12.7 count of abscess and inflammatory nodule
STANDARD_DEVIATION 9.34 • n=149 Participants
|
|
Worst Pain Numeric Rating Scale (NRS) Score
|
5.3 units on a scale
STANDARD_DEVIATION 2.54 • n=49 Participants • ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline.
|
5.4 units on a scale
STANDARD_DEVIATION 2.81 • n=49 Participants • ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline.
|
5.6 units on a scale
STANDARD_DEVIATION 2.79 • n=49 Participants • ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline.
|
5.4 units on a scale
STANDARD_DEVIATION 2.70 • n=147 Participants • ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline.
|
|
Average pain NRS Score
|
5.7 units on a scale
STANDARD_DEVIATION 2.61 • n=49 Participants • ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline.
|
6.0 units on a scale
STANDARD_DEVIATION 2.71 • n=50 Participants • ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline.
|
5.7 units on a scale
STANDARD_DEVIATION 2.60 • n=49 Participants • ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline.
|
5.8 units on a scale
STANDARD_DEVIATION 2.63 • n=148 Participants • ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline.
|
|
Hurley Stage
Hurley Stage Il
|
36 Participants
n=50 Participants
|
38 Participants
n=50 Participants
|
37 Participants
n=49 Participants
|
111 Participants
n=149 Participants
|
|
Hurley Stage
Hurley Stage IIl
|
14 Participants
n=50 Participants
|
12 Participants
n=50 Participants
|
12 Participants
n=49 Participants
|
38 Participants
n=149 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: ITT Analysis Set with available data was analyzed.
The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
Outcome measures
| Measure |
Placebo-Controlled Period: Imsidolimab 400/200 mg
n=39 Participants
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Imsidolimab 200/100 mg
n=41 Participants
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Placebo
n=42 Participants
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Extension Period: Placebo to Imsidolimab 200/100 mg
Participants who received placebo in placebo-controlled period, received 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection in extension period.
|
|---|---|---|---|---|
|
Change From Baseline in AN Count at Week 16: Placebo-Controlled Period
|
-5.9 count of abscess and inflammatory nodule
Standard Deviation 6.05
|
-4.1 count of abscess and inflammatory nodule
Standard Deviation 4.63
|
-5.6 count of abscess and inflammatory nodule
Standard Deviation 7.40
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT Analysis Set with available data was analyzed.
The AN count was defined as the sum of the number of abscesses and inflammatory nodules from all locations.
Outcome measures
| Measure |
Placebo-Controlled Period: Imsidolimab 400/200 mg
n=39 Participants
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Imsidolimab 200/100 mg
n=41 Participants
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Placebo
n=42 Participants
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Extension Period: Placebo to Imsidolimab 200/100 mg
Participants who received placebo in placebo-controlled period, received 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection in extension period.
|
|---|---|---|---|---|
|
Percent Change From Baseline in AN Count at Week 16: Placebo-Controlled Period
|
-44.7 percent change
Standard Deviation 39.23
|
-36.7 percent change
Standard Deviation 36.59
|
-41.2 percent change
Standard Deviation 43.69
|
—
|
SECONDARY outcome
Timeframe: Week 16Population: ITT Analysis Set with available data was analyzed.
The number of participants with at least a 50% decrease from Baseline AN count, and no increase in abscesses or draining fistulas in comparison to baseline (HiSCR50) at Week 16 was calculated for each treatment group as follows: A responder HiSCR50 was defined as a participant with 1. at least a 50% decrease in AN count from Baseline, and 2. no increase in abscess count relative to Baseline, and 3. no increase in draining fistula count relative to Baseline
Outcome measures
| Measure |
Placebo-Controlled Period: Imsidolimab 400/200 mg
n=39 Participants
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Imsidolimab 200/100 mg
n=41 Participants
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Placebo
n=42 Participants
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Extension Period: Placebo to Imsidolimab 200/100 mg
Participants who received placebo in placebo-controlled period, received 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection in extension period.
|
|---|---|---|---|---|
|
Number of Participants Achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50): Placebo-Controlled Period
|
16 Participants
|
16 Participants
|
15 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline.
Participants were asked to assign a numerical score representing the HS worst pain intensity over the last 24 hours on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms).
Outcome measures
| Measure |
Placebo-Controlled Period: Imsidolimab 400/200 mg
n=39 Participants
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Imsidolimab 200/100 mg
n=40 Participants
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Placebo
n=42 Participants
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Extension Period: Placebo to Imsidolimab 200/100 mg
Participants who received placebo in placebo-controlled period, received 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection in extension period.
|
|---|---|---|---|---|
|
Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period
|
-0.3 units on a scale
Standard Deviation 2.89
|
-0.7 units on a scale
Standard Deviation 2.37
|
-0.4 units on a scale
Standard Deviation 3.22
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline.
Participants were asked to assign a numerical score representing the average intensity over the last 7 days of their HS pain symptoms on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms).
Outcome measures
| Measure |
Placebo-Controlled Period: Imsidolimab 400/200 mg
n=39 Participants
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Imsidolimab 200/100 mg
n=41 Participants
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Placebo
n=42 Participants
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Extension Period: Placebo to Imsidolimab 200/100 mg
Participants who received placebo in placebo-controlled period, received 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection in extension period.
|
|---|---|---|---|---|
|
Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period
|
-0.5 units on a scale
Standard Deviation 2.29
|
-1.0 units on a scale
Standard Deviation 2.48
|
-0.5 units on a scale
Standard Deviation 2.74
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline. "Overall number of participants analyzed" included only those participants with Baseline score of \>0.
Participants were asked to assign a numerical score representing the HS worst pain intensity over the last 24 hours on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms). Only participants that had Baseline score of \>0 could be included in the analysis of Percent Change from Baseline.
Outcome measures
| Measure |
Placebo-Controlled Period: Imsidolimab 400/200 mg
n=37 Participants
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Imsidolimab 200/100 mg
n=38 Participants
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Placebo
n=40 Participants
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Extension Period: Placebo to Imsidolimab 200/100 mg
Participants who received placebo in placebo-controlled period, received 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection in extension period.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Worst HS Pain NRS Score at Week 16: Placebo-Controlled Period
|
7.6 percent change
Standard Deviation 81.81
|
10.2 percent change
Standard Deviation 146.92
|
30.3 percent change
Standard Deviation 136.89
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: ITT Analysis Set with available data was analyzed; change and percent change in worst HS pain NRS and change and percent change in average HS pain NRS are 2 different CRF questions, and so the number of responses can (and do) differ between the questions at baseline. "Overall number of participants analyzed" included only those participants with Baseline score of \>0.
Participants were asked to assign a numerical score representing the average intensity over the last 7 days of their HS pain symptoms on a scale from 0 (no symptoms) to 10 (worst imaginable symptoms). Only participants that had Baseline score of \>0 could be included in the analysis of Percent Change from Baseline.
Outcome measures
| Measure |
Placebo-Controlled Period: Imsidolimab 400/200 mg
n=37 Participants
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Imsidolimab 200/100 mg
n=39 Participants
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Placebo
n=41 Participants
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Extension Period: Placebo to Imsidolimab 200/100 mg
Participants who received placebo in placebo-controlled period, received 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection in extension period.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Average HS Pain NRS Score at Week 16: Placebo-Controlled Period
|
-1.3 percent change
Standard Deviation 58.54
|
-18.3 percent change
Standard Deviation 37.76
|
4.5 percent change
Standard Deviation 77.25
|
—
|
SECONDARY outcome
Timeframe: From first dose (placebo-controlled period) up to Week 16Population: Safety analysis set included all randomized participants who received at least 1 dose of imsidolimab or placebo.
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was considered treatment-emergent if the date of onset was during or after first dose of study treatment during placebo-controlled period, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.
Outcome measures
| Measure |
Placebo-Controlled Period: Imsidolimab 400/200 mg
n=50 Participants
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Imsidolimab 200/100 mg
n=50 Participants
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Placebo
n=49 Participants
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Extension Period: Placebo to Imsidolimab 200/100 mg
Participants who received placebo in placebo-controlled period, received 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection in extension period.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs): Placebo-Controlled Period
|
19 Participants
|
14 Participants
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: From first dose (extension period) up to Week 40Population: Extension Analysis Set included subset of the safety analysis set who received at least 1 dose of imsidolimab in the extension period.
An AE was any untoward medical occurrence in a participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was considered treatment-emergent if the date of onset was during or after first dose of study treatment in extension period, or if the AE present at baseline worsened in either intensity or frequency after first dose of study treatment.
Outcome measures
| Measure |
Placebo-Controlled Period: Imsidolimab 400/200 mg
n=40 Participants
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Imsidolimab 200/100 mg
n=42 Participants
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Placebo
n=19 Participants
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Extension Period: Placebo to Imsidolimab 200/100 mg
n=21 Participants
Participants who received placebo in placebo-controlled period, received 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection in extension period.
|
|---|---|---|---|---|
|
Number of Participants With TEAEs: Extension and Follow-up Period
|
15 Participants
|
18 Participants
|
9 Participants
|
10 Participants
|
Adverse Events
Placebo-Controlled Period: Imsidolimab 400/200 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo-Controlled Period: Imsidolimab 200/100 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo-Controlled Period: Placebo
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Extension Period: Imsidolimab 400/200 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Extension Period: Imsidolimab 200/100 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Extension Period: Placebo to Imsidolimab 400/200 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Extension Period: Placebo to Imsidolimab 200/100 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo-Controlled Period: Imsidolimab 400/200 mg
n=50 participants at risk
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Imsidolimab 200/100 mg
n=50 participants at risk
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Placebo
n=49 participants at risk
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Extension Period: Imsidolimab 400/200 mg
n=40 participants at risk
Participants received a dose of 400 mg of imsidolimab on Day 113, followed by a dose of 200 mg on Days 141, 169, and 197 by SC injection.
|
Extension Period: Imsidolimab 200/100 mg
n=42 participants at risk
Participants received a dose of 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection.
|
Extension Period: Placebo to Imsidolimab 400/200 mg
n=19 participants at risk
Participants who received placebo in placebo-controlled period, received 400 mg of imsidolimab on Day 113, followed by a dose of 200 mg on Days 141, 169, and 197 by SC injection in extension period.
|
Extension Period: Placebo to Imsidolimab 200/100 mg
n=21 participants at risk
Participants who received placebo in placebo-controlled period, received 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection in extension period.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
4.0%
2/50 • Number of events 2 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/19 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Infections and infestations
Abscess limb
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
2.0%
1/49 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/19 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
2.0%
1/49 • Number of events 2 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/19 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
2.0%
1/49 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
2.4%
1/42 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/19 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
Other adverse events
| Measure |
Placebo-Controlled Period: Imsidolimab 400/200 mg
n=50 participants at risk
Participants received a starting dose of 400 mg of imsidolimab on Day 1 followed by 200 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Imsidolimab 200/100 mg
n=50 participants at risk
Participants received a starting dose of 200 mg of imsidolimab on Day 1 followed by 100 mg imsidolimab every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Placebo-Controlled Period: Placebo
n=49 participants at risk
Participants received imsidolimab matching placebo on Day 1 and thereafter, every 4 weeks (Days 29, 57 and 85) by SC injection.
|
Extension Period: Imsidolimab 400/200 mg
n=40 participants at risk
Participants received a dose of 400 mg of imsidolimab on Day 113, followed by a dose of 200 mg on Days 141, 169, and 197 by SC injection.
|
Extension Period: Imsidolimab 200/100 mg
n=42 participants at risk
Participants received a dose of 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection.
|
Extension Period: Placebo to Imsidolimab 400/200 mg
n=19 participants at risk
Participants who received placebo in placebo-controlled period, received 400 mg of imsidolimab on Day 113, followed by a dose of 200 mg on Days 141, 169, and 197 by SC injection in extension period.
|
Extension Period: Placebo to Imsidolimab 200/100 mg
n=21 participants at risk
Participants who received placebo in placebo-controlled period, received 200 mg of imsidolimab on Day 113, followed by a dose of 100 mg on Days 141, 169, and 197 by SC injection in extension period.
|
|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Infections and infestations
COVID-19
|
8.0%
4/50 • Number of events 4 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
6.0%
3/50 • Number of events 3 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
6.1%
3/49 • Number of events 3 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.0%
2/40 • Number of events 2 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
7.1%
3/42 • Number of events 3 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/19 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
14.3%
3/21 • Number of events 3 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
2.0%
1/50 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
6.0%
3/50 • Number of events 3 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
8.2%
4/49 • Number of events 6 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
7.5%
3/40 • Number of events 4 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
4.8%
2/42 • Number of events 2 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 3 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
6.1%
3/49 • Number of events 3 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
2.5%
1/40 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
7.1%
3/42 • Number of events 3 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.0%
2/40 • Number of events 2 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
4.8%
1/21 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
2.5%
1/40 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
10.5%
2/19 • Number of events 2 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
2.5%
1/40 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
4.8%
1/21 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Infections and infestations
Sinusitis
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
2.5%
1/40 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
2.4%
1/42 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
2.5%
1/40 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 2 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
2.5%
1/40 • Number of events 2 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
10.5%
2/19 • Number of events 2 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
2.4%
1/42 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Vascular disorders
Hypertension
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
2.4%
1/42 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Infections and infestations
Bronchitis
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
General disorders
Fatigue
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
General disorders
Pyrexia
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Infections and infestations
Sepsis
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/50 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/49 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/40 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/42 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
5.3%
1/19 • Number of events 1 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
0.00%
0/21 • From first dose up to Week 40
Placebo-Controlled Period: Safety Analysis Set Extension Period: Extension Analysis Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER