Trial Outcomes & Findings for A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (NCT NCT04988308)

Last Updated: 2023-11-13

Results Overview

HiSCR50 was defined as at least 50 percent (%) reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

151 participants

Primary outcome timeframe

Week 16

Results posted on

2023-11-13

Participant Flow

As per change in planned analysis, Part 2 of this study was not conducted due to early termination because interim analysis 1 efficacy results met the prespecified futility criteria related to the primary endpoint. Hence, data for Part 2 and some secondary efficacy outcome measures (Parts 1 and 2) were not reported in this results summary.

Participant milestones

Participant milestones
Measure	Part 1: Placebo (Week 0-16) Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-36) Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1. Participants who received bermekimab 1050 mg (3\*350 mg) at Week 16 entered into active treatment + safety follow up (FU) period and received bermekimab 1050 mg as SC injection weekly through Week 36 in Part 1.	Part 1: Adalimumab (Week 0-16) Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.	Part 1: Placebo Then Bermekimab (Week 17-36) Participants who received placebo during placebo controlled period and then received bermekimab 1050 mg (3\*350 mg) at Week 16 entered into active treatment + safety follow up (FU) period and received bermekimab 1050 mg as SC injection weekly through Week 31 in Part 1. All participants were followed for safety through Week 36.	Part 1: Bermekimab (Week 17-36) Participants who received bermekimab 1050 mg at Week 16 during placebo controlled period entered into active treatment + safety FU period and continued to receive bermekimab 1050 mg (3\*350 mg) as SC injection every week thereafter through Week 31. All participants were followed for safety through Week 36.	Part 1: Adalimumab (Week 17-36) Participants who received adalimumab 40 mg as SC injection during placebo controlled period entered into active treatment period and continued to receive adalimumab 40 mg as SC injection and 2 placebo SC injections weekly through Week 31 in Part 1. All participants were followed for safety through Week 36.
Placebo Controlled Period (Weeks 0-16) STARTED	50	51	50	0	0	0
Placebo Controlled Period (Weeks 0-16) Full- Analysis Set (FAS)	35	35	35	0	0	0
Placebo Controlled Period (Weeks 0-16) COMPLETED	28	30	28	0	0	0
Placebo Controlled Period (Weeks 0-16) NOT COMPLETED	22	21	22	0	0	0
Active Treatment+Safety F-U (Week 17-36) STARTED	0	0	0	28	30	28
Active Treatment+Safety F-U (Week 17-36) COMPLETED	0	0	0	7	9	10
Active Treatment+Safety F-U (Week 17-36) NOT COMPLETED	0	0	0	21	21	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Part 1: Placebo (Week 0-16) Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-36) Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1. Participants who received bermekimab 1050 mg (3\*350 mg) at Week 16 entered into active treatment + safety follow up (FU) period and received bermekimab 1050 mg as SC injection weekly through Week 36 in Part 1.	Part 1: Adalimumab (Week 0-16) Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.	Part 1: Placebo Then Bermekimab (Week 17-36) Participants who received placebo during placebo controlled period and then received bermekimab 1050 mg (3\*350 mg) at Week 16 entered into active treatment + safety follow up (FU) period and received bermekimab 1050 mg as SC injection weekly through Week 31 in Part 1. All participants were followed for safety through Week 36.	Part 1: Bermekimab (Week 17-36) Participants who received bermekimab 1050 mg at Week 16 during placebo controlled period entered into active treatment + safety FU period and continued to receive bermekimab 1050 mg (3\*350 mg) as SC injection every week thereafter through Week 31. All participants were followed for safety through Week 36.	Part 1: Adalimumab (Week 17-36) Participants who received adalimumab 40 mg as SC injection during placebo controlled period entered into active treatment period and continued to receive adalimumab 40 mg as SC injection and 2 placebo SC injections weekly through Week 31 in Part 1. All participants were followed for safety through Week 36.
Placebo Controlled Period (Weeks 0-16) Withdrawal by Subject	2	4	4	0	0	0
Placebo Controlled Period (Weeks 0-16) Death	0	0	1	0	0	0
Placebo Controlled Period (Weeks 0-16) Lost to Follow-up	4	4	0	0	0	0
Placebo Controlled Period (Weeks 0-16) Other	10	9	14	0	0	0
Placebo Controlled Period (Weeks 0-16) Study terminated by sponsor	6	4	3	0	0	0
Active Treatment+Safety F-U (Week 17-36) Withdrawal by Subject	0	0	0	3	2	1
Active Treatment+Safety F-U (Week 17-36) Lost to Follow-up	0	0	0	3	3	1
Active Treatment+Safety F-U (Week 17-36) Other	0	0	0	10	10	14
Active Treatment+Safety F-U (Week 17-36) Study terminated by sponsor	0	0	0	5	6	2

Baseline Characteristics

A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Placebo (Week 0-16) n=50 Participants Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-36) n=51 Participants Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1. Participants who received bermekimab 1050 mg (3\*350 mg) at Week 16 entered into active treatment + safety follow up (FU) period and received bermekimab 1050 mg as SC injection weekly through Week 36 in Part 1.	Part 1: Adalimumab (Week 0-16) n=50 Participants Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.	Total n=151 Participants Total of all reporting groups
Age, Continuous	38.1 years STANDARD_DEVIATION 12.55 • n=5 Participants	36.7 years STANDARD_DEVIATION 9.67 • n=7 Participants	35.7 years STANDARD_DEVIATION 12.2 • n=5 Participants	36.8 years STANDARD_DEVIATION 11.5 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	30 Participants n=7 Participants	28 Participants n=5 Participants	83 Participants n=4 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	21 Participants n=7 Participants	22 Participants n=5 Participants	68 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	42 Participants n=7 Participants	41 Participants n=5 Participants	121 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	18 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	17 Participants n=4 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	37 Participants n=7 Participants	32 Participants n=5 Participants	101 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment AUSTRALIA	1 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants
Region of Enrollment CANADA	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Region of Enrollment GERMANY	12 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	32 Participants n=4 Participants
Region of Enrollment JAPAN	5 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment NETHERLANDS	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment POLAND	5 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	20 Participants n=4 Participants
Region of Enrollment SPAIN	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment UNITED STATES	21 Participants n=5 Participants	20 Participants n=7 Participants	21 Participants n=5 Participants	62 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 16

Population: The full analysis set (FAS) included all randomized participants who received at least one administration of study intervention.

Outcome measures

Outcome measures
Measure	Part 1: Placebo (Week 0-16) n=35 Participants Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-16) n=35 Participants Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1.	Part 1: Adalimumab (Week 0-16) n=35 Participants Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.
Part 1: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16	37.1 Percentage of participants	37.1 Percentage of participants	57.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: The FAS included all randomized participants who received at least one administration of study intervention.

HiSCR75 was defined as at least 75% reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline.

Outcome measures

Outcome measures
Measure	Part 1: Placebo (Week 0-16) n=35 Participants Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-16) n=35 Participants Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1.	Part 1: Adalimumab (Week 0-16) n=35 Participants Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.
Part 1: Percentage of Participants Who Achieved HiSCR75 at Week 16	25.7 Percentage of participants	25.7 Percentage of participants	40.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 16

Population: The FAS included all randomized participants who received at least one administration of study intervention.

HiSCR90 was defined as at least 90% reduction in total abscess and inflammatory nodule counts (AN count) with no increase in abscess count and no increase in draining fistula count relative to baseline.

Outcome measures

Outcome measures
Measure	Part 1: Placebo (Week 0-16) n=35 Participants Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-16) n=35 Participants Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1.	Part 1: Adalimumab (Week 0-16) n=35 Participants Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.
Part 1: Percentage of Participants Who Achieved HiSCR90 at Week 16	14.3 Percentage of participants	17.1 Percentage of participants	22.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 16

Population: The FAS included all randomized participants who received at least one administration of study intervention. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Change from baseline in the AN count as Week 16 was reported. Abscess and inflammatory nodule were counted for the hidradenitis suppurativa (HS) affected anatomical regions. The AN count is the sum of number of abscess and inflammatory nodules across anatomical regions.

Outcome measures

Outcome measures
Measure	Part 1: Placebo (Week 0-16) n=28 Participants Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-16) n=29 Participants Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1.	Part 1: Adalimumab (Week 0-16) n=28 Participants Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.
Part 1: Change From Baseline in the Abscess and Inflammatory Nodule (AN) Count at Week 16	-4.50 Abscess and inflammatory nodule Standard Deviation 5.088	-5.31 Abscess and inflammatory nodule Standard Deviation 8.594	-7.25 Abscess and inflammatory nodule Standard Deviation 4.774

SECONDARY outcome

Timeframe: Baseline, Week 16

Change from baseline in number of abscess at Week 16 was reported.

Outcome measures

Outcome measures
Measure	Part 1: Placebo (Week 0-16) n=28 Participants Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-16) n=29 Participants Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1.	Part 1: Adalimumab (Week 0-16) n=28 Participants Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.
Part 1: Change From Baseline in Number of Abscess at Week 16	-0.86 Abscess Standard Deviation 1.900	-0.83 Abscess Standard Deviation 3.071	-1.46 Abscess Standard Deviation 2.333

SECONDARY outcome

Timeframe: Baseline, Week 16

Change from baseline in number of draining fistula at Week 16 was reported. Draining fistula was defined as fistulas that drain serous or purulent fluid, either spontaneously or by gentle palpation.

Outcome measures

Outcome measures
Measure	Part 1: Placebo (Week 0-16) n=28 Participants Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-16) n=29 Participants Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1.	Part 1: Adalimumab (Week 0-16) n=28 Participants Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.
Part 1: Change From Baseline in Number of Draining Fistula at Week 16	-0.04 fistulas Standard Deviation 1.915	-1.00 fistulas Standard Deviation 1.626	-0.96 fistulas Standard Deviation 1.575

SECONDARY outcome

Timeframe: Baseline, Week 16

Change from baseline in number of inflammatory nodules at Week 16 was reported. Inflammatory nodules arise from inflamed blood vessels (vasculitis) or adipose tissue (panniculitis).

Outcome measures

Outcome measures
Measure	Part 1: Placebo (Week 0-16) n=28 Participants Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-16) n=29 Participants Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1.	Part 1: Adalimumab (Week 0-16) n=28 Participants Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.
Part 1: Change From Baseline in Number of Inflammatory Nodules at Week 16	-3.64 inflammatory nodules Standard Deviation 5.258	-4.48 inflammatory nodules Standard Deviation 7.689	-5.79 inflammatory nodules Standard Deviation 4.306

SECONDARY outcome

Timeframe: Baseline up to Week 16

IHS4 was a dynamic severity assessment of HS. IHS4 score was arrived at by the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A total score of 3 or less signifies mild, 4-10 signifies moderate and 11 or higher signifies severe disease. Higher scores indicate more severity.

Outcome measures

Outcome measures
Measure	Part 1: Placebo (Week 0-16) n=28 Participants Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-16) n=29 Participants Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1.	Part 1: Adalimumab (Week 0-16) n=28 Participants Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.
Part 1: Change From Baseline in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 16	-5.5 scores on a scale Standard Deviation 10.38	-10.14 scores on a scale Standard Deviation 13.36	-12.6 scores on a scale Standard Deviation 9.15

SECONDARY outcome

Timeframe: Baseline, Week 16

The HS-IGA documents the investigator's assessment of the participant's HS at a given timepoint. The anatomic region with the most severe HS activity at the baseline was evaluated for erythema, drainage, and pain and/or tenderness to palpation for each participant. The participant's HS was assessed as inactive (0), almost inactive (1), mild activity (2), moderate activity (3), or severe activity (4). A higher score indicates more severe disease. Percentage of participants with HS-IGA score of inactive (0), almost inactive (1), or mild activity (2) and with at least 2-grade improvement relative to baseline at Week 16 were reported.

Outcome measures

Outcome measures
Measure	Part 1: Placebo (Week 0-16) n=35 Participants Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-16) n=35 Participants Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1.	Part 1: Adalimumab (Week 0-16) n=34 Participants Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.
Part 1: Percentage of Participants With Hidradenitis Suppurativa-Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-grade Improvement Relative to Baseline at Week 16 HS-IGA scores of inactive (0)	11.4 Percentage of participants	17.1 Percentage of participants	20.6 Percentage of participants
Part 1: Percentage of Participants With Hidradenitis Suppurativa-Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-grade Improvement Relative to Baseline at Week 16 HS-IGA scores of inactive (0) or almost active (1)	25.7 Percentage of participants	25.7 Percentage of participants	38.2 Percentage of participants
Part 1: Percentage of Participants With Hidradenitis Suppurativa-Investigator's Global Assessment (HS-IGA) Score of Inactive (0), Almost Inactive (1), or Mild Activity (2) and With at Least 2-grade Improvement Relative to Baseline at Week 16 HS-IGA scores of inactive (0), or or almost active (1), or mild activity (2)	28.6 Percentage of participants	28.6 Percentage of participants	38.2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 16

HSSD is a 7-item patient self-reported questionnaire that assesses 5 HS-related symptoms including pain, tenderness, hot skin feeling, odor, and itchiness. The participants were asked to rate the severity of each symptom on a 0 to 10 numerical rating scale, with 0 indicating no symptom experience and 10 indicating the worst possible symptom experience. All 5 symptoms have a recall period of the past 7 days, except for 2 additional questions on pain which evaluate current pain and pain in the past 24 hours with a score range from 0 (no symptom experience) to 10 (worst possible symptom experience). A total symptom score also ranged from 0 (no symptom) to 10 (worst possible symptom), was derived by averaging the 5 individual scale scores that utilize the past 7-day recall period. Change from baseline in HS-related pain symptom score in the past 24 hours based on HSSD was reported.

Outcome measures

Outcome measures
Measure	Part 1: Placebo (Week 0-16) n=20 Participants Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-16) n=22 Participants Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1.	Part 1: Adalimumab (Week 0-16) n=20 Participants Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.
Part 1: Change From Baseline in Hidradenitis Suppurativa (HS)-Related Pain Symptom Score in the Past 24 Hours Based on Hidradenitis Suppurativa Symptom Diary (HSSD) Questionnaire at Week 16	-1.00 scores on a scale Standard Deviation 2.461	-0.41 scores on a scale Standard Deviation 2.374	-1.96 scores on a scale Standard Deviation 2.326

SECONDARY outcome

Timeframe: Weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36

Population: The pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of bermekimab and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at each specified timepoint.

Serum concentration of bermekimab was reported. As per planned analysis, this outcome measure was analyzed in a single arm for participants who received bermekimab from Week 0 to Week 36.

Outcome measures

Outcome measures
Measure	Part 1: Placebo (Week 0-16) n=50 Participants Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-16) Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1.	Part 1: Adalimumab (Week 0-16) Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.
Serum Concentration of Bermekimab Week 0	0.00 micrograms per milliliter (mcg/mL) Standard Deviation 0.000	—	—
Serum Concentration of Bermekimab Week1	51.36 micrograms per milliliter (mcg/mL) Standard Deviation 20.354	—	—
Serum Concentration of Bermekimab Week 4	78.46 micrograms per milliliter (mcg/mL) Standard Deviation 43.897	—	—
Serum Concentration of Bermekimab Week 8	73.14 micrograms per milliliter (mcg/mL) Standard Deviation 37.583	—	—
Serum Concentration of Bermekimab Week 12	72.45 micrograms per milliliter (mcg/mL) Standard Deviation 39.185	—	—
Serum Concentration of Bermekimab Week 16	61.81 micrograms per milliliter (mcg/mL) Standard Deviation 42.092	—	—
Serum Concentration of Bermekimab Week 20	74.68 micrograms per milliliter (mcg/mL) Standard Deviation 59.300	—	—
Serum Concentration of Bermekimab Week 24	89.75 micrograms per milliliter (mcg/mL) Standard Deviation 50.940	—	—
Serum Concentration of Bermekimab Week 28	66.30 micrograms per milliliter (mcg/mL) Standard Deviation 57.219	—	—
Serum Concentration of Bermekimab Week 32	34.53 micrograms per milliliter (mcg/mL) Standard Deviation 36.160	—	—
Serum Concentration of Bermekimab Week 36	4.63 micrograms per milliliter (mcg/mL) Standard Deviation 7.576	—	—

SECONDARY outcome

Timeframe: From baseline up to Week 36

Population: The immunogenicity analysis set included all participants who received at least 1 dose of bermekimab and who had at least 1 sample obtained after their first dose of bermekimab for the detection of antibodies to bermekimab.

Number of participants with antibodies to bermekimab was reported. As per planned analysis, this outcome measure was analyzed in a single arm for participants who received bermekimab from Week 0 to Week 36.

Outcome measures

Outcome measures
Measure	Part 1: Placebo (Week 0-16) n=51 Participants Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-16) Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1.	Part 1: Adalimumab (Week 0-16) Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.
Number of Participants With Antibodies to Bermekimab	16 Participants	—	—

Adverse Events

Part 1: Placebo (Week 0-16)

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Part 1: Bermekimab (Week 0-36)

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

Part 1: Adalimumab (Week 0-16)

Serious events: 4 serious events

Other events: 22 other events

Deaths: 1 deaths

Part 1: Placebo Then Bermekimab (Week 17-36)

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Part 1: Bermekimab (Week 17-36)

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Part 1: Adalimumab (Week 17-36)

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part 1: Placebo (Week 0-16) n=50 participants at risk Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-36) n=51 participants at risk Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1. Participants who received bermekimab 1050 mg (3\*350 mg) at Week 16 entered into active treatment + safety follow up (FU) period and received bermekimab 1050 mg as SC injection weekly through Week 36 in Part 1.	Part 1: Adalimumab (Week 0-16) n=50 participants at risk Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.	Part 1: Placebo Then Bermekimab (Week 17-36) n=28 participants at risk Participants who received placebo during placebo controlled period and then received bermekimab 1050 mg (3\*350 mg) at Week 16 entered into active treatment + safety follow up (FU) period and received bermekimab 1050 mg as SC injection weekly through Week 31 in Part 1. All participants were followed for safety through Week 36.	Part 1: Bermekimab (Week 17-36) n=30 participants at risk Participants who received bermekimab 1050 mg at Week 16 during placebo controlled period entered into active treatment + safety FU period and continued to receive bermekimab 1050 mg (3\*350 mg) as SC injection every week thereafter through Week 31. All participants were followed for safety through Week 36.	Part 1: Adalimumab (Week 17-36) n=28 participants at risk Participants who received adalimumab 40 mg as SC injection during placebo controlled period entered into active treatment period and continued to receive adalimumab 40 mg as SC injection and 2 placebo SC injections weekly through Week 31 in Part 1. All participants were followed for safety through Week 36.
Cardiac disorders Cardiac Failure Congestive	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	2.0% 1/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
General disorders Chest Pain	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	2.0% 1/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Cellulitis	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	2.0% 1/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Covid-19	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	3.3% 1/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Pneumonia Mycoplasmal	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	2.0% 1/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Skin Bacterial Infection	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	2.0% 1/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Injury, poisoning and procedural complications Toxicity to Various Agents	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	2.0% 1/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Investigations Alanine Aminotransferase Increased	2.0% 1/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	3.6% 1/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Hidradenitis	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	2.0% 1/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Vascular disorders Arterial Occlusive Disease	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	2.0% 1/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.

Other adverse events

Other adverse events
Measure	Part 1: Placebo (Week 0-16) n=50 participants at risk Participants received placebo as subcutaneous (SC) injection from Week 0 through Week 15 and then participants received bermekimab 1050 milligrams (mg) as SC injection at Week 16 in Part 1.	Part 1: Bermekimab (Week 0-36) n=51 participants at risk Participants received bermekimab 1050 mg (3\350 mg) and 1 placebo as SC injection at Week 0 followed by bermekimab 1050 mg (3\350 mg) as SC injection at Week 1 and every week thereafter through Week 16 in Part 1. Participants who received bermekimab 1050 mg (3\*350 mg) at Week 16 entered into active treatment + safety follow up (FU) period and received bermekimab 1050 mg as SC injection weekly through Week 36 in Part 1.	Part 1: Adalimumab (Week 0-16) n=50 participants at risk Participants received adalimumab 160 mg (4\40 mg) as SC injection at Week 0 and 3 placebo SC injections at Week 1 followed by adalimumab 80 mg (2\40 mg) as SC injection at Week 2 and 3 placebo SC injections at Week 3. Participants received adalimumab 40 mg (1\*40 mg) SC injection and 2 placebo SC injections at Week 4 and every week thereafter through Week 16 in Part 1.	Part 1: Placebo Then Bermekimab (Week 17-36) n=28 participants at risk Participants who received placebo during placebo controlled period and then received bermekimab 1050 mg (3\*350 mg) at Week 16 entered into active treatment + safety follow up (FU) period and received bermekimab 1050 mg as SC injection weekly through Week 31 in Part 1. All participants were followed for safety through Week 36.	Part 1: Bermekimab (Week 17-36) n=30 participants at risk Participants who received bermekimab 1050 mg at Week 16 during placebo controlled period entered into active treatment + safety FU period and continued to receive bermekimab 1050 mg (3\*350 mg) as SC injection every week thereafter through Week 31. All participants were followed for safety through Week 36.	Part 1: Adalimumab (Week 17-36) n=28 participants at risk Participants who received adalimumab 40 mg as SC injection during placebo controlled period entered into active treatment period and continued to receive adalimumab 40 mg as SC injection and 2 placebo SC injections weekly through Week 31 in Part 1. All participants were followed for safety through Week 36.
Infections and infestations Nasopharyngitis	4.0% 2/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	7.8% 4/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	8.0% 4/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	7.1% 2/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	6.7% 2/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	10.7% 3/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Upper Respiratory Tract Infection	4.0% 2/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	7.8% 4/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	6.0% 3/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	3.6% 1/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	10.0% 3/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	7.1% 2/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Nausea	2.0% 1/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	9.8% 5/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	8.0% 4/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	3.6% 1/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Gastrointestinal disorders Vomiting	6.0% 3/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	6.0% 3/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	7.1% 2/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	3.6% 1/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
General disorders Fatigue	4.0% 2/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	2.0% 1/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	6.0% 3/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
General disorders Injection Site Erythema	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	31.4% 16/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	6.0% 3/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	17.9% 5/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	3.3% 1/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
General disorders Injection Site Pruritus	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	17.6% 9/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	2.0% 1/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	17.9% 5/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Bacterial Vaginosis	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	2.0% 1/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	6.7% 2/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Infections and infestations Covid-19	10.0% 5/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	7.8% 4/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	6.0% 3/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	3.6% 1/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	6.7% 2/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	14.3% 4/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Investigations C-Reactive Protein Increased	2.0% 1/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	5.9% 3/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	2.0% 1/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Nervous system disorders Headache	6.0% 3/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	11.8% 6/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	12.0% 6/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	3.6% 1/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	5.9% 3/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	3.6% 1/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	3.6% 1/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	2.0% 1/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	5.9% 3/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	3.6% 1/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.
Skin and subcutaneous tissue disorders Hidradenitis	12.0% 6/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	5.9% 3/51 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	2.0% 1/50 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	0.00% 0/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	13.3% 4/30 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.	3.6% 1/28 • Part 1: Placebo Controlled Period: From Week 0 to Week 16; Active Treatment + Safety Follow-up Period: From Week 17 to Week 36 The safety analysis set included all randomized participants who received at least 1 dose of study intervention.

Additional Information

Director Clinical Research Dermatology

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER