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

Conditions

• Hidradenitis Suppurativa

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bermekimab — DRUG
  Bermekimab will be administered subcutaneously.
• Adalimumab — DRUG
  Adalimumab will be administered subcutaneously.
• Placebo — DRUG
  Placebo will be administered subcutaneously.

Study Details

The purpose of this study is to evaluate the clinical efficacy of bermekimab in participants with moderate to severe Hidradenitis Suppurativa (HS).

Key Dates

Start date

Oct 12, 2021

Status verified

Oct 2023

Primary completion

Oct 14, 2022

Completion

Nov 23, 2022

Study Design

Enrollment

151 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Part 1 (Group 1): Placebo
  Participants will receive placebo subcutaneously (SC) at Week 0 through Week 15. At Week 16, participants will cross over to receive bermekimab dose 1 SC every week thereafter through Week 31.
• Active Comparator: Part 1 (Group 2): Adalimumab
  Participants will receive adalimumab 160 milligrams (mg) SC at Week 0, placebo SC at Week 1, followed by adalimumab 80 mg SC and placebo SC at Weeks 2 and 3. Participants will then receive adalimumab 40 mg SC and placebo SC at Week 4 and every week thereafter through Week 31.
• Experimental: Part 1 (Group 3): Bermekimab Dose 1
  Participants will receive bermekimab dose 1 SC and placebo SC at Week 0, followed by bermekimab dose 1 SC at Week 1 and every week thereafter through Week 31.
• Placebo Comparator: Part 2 (Group 1): Placebo
  Participants will receive placebo SC from Week 0 through Week 11. At Week 12, participants will cross over to receive bermekimab dose 1 SC weekly through Week 31.
• Experimental: Part 2 (Group 2): Bermekimab Dose 1
  Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 31.
• Experimental: Part 2 (Group 3): Bermekimab Dose 1
  Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 11. From Week 12, participants will receive bermekimab dose 1 SC every other week thereafter through Week 30. During weeks in which bermekimab is not administered, participants will receive placebo SC through Week 31.
• Experimental: Part 2 (Group 4): Bermekimab Dose 2
  Participants will receive bermekimab dose 2 SC and placebo SC at Week 0 and every week thereafter through Week 11. From Week 12, participants will receive bermekimab dose 2 SC and placebo SC every other week thereafter through Week 30. During weeks in which bermekimab is not administered, participants will receive placebo SC through Week 31.

Primary Outcome Measure

Part 1: Percentage of Participants Who Achieved Hidradenitis Suppurativa Clinical Response-50 (HiSCR50) at Week 16 [ Time Frame: Week 16 ]

Locations (22)

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