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Monoclonal Antibodies

A Study of Bermekimab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (LYRA Trial)

Phase 2

Waitlist Available

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36

Summary

This trial is testing bermekimab, a medicine made from human antibodies, in people with moderate to severe Hidradenitis Suppurativa (HS). HS is a painful skin condition, and bermekimab aims to reduce inflammation by blocking a protein called IL-1 alpha. The study will last several months and will monitor safety and effectiveness.

Eligible Conditions

Hidradenitis Suppurativa

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 1, 4, 8, 12, 16, 20, 24, 28, 32, 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Number of Participants With Antibodies to Bermekimab

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

Part 1: Change From Baseline in International Hidradenitis Suppurativa Severity Score (IHS4) at Week 16

+8 more

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Part 2 (Group 4): Bermekimab Dose 2Experimental Treatment2 Interventions

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.

Group II: Part 2 (Group 3): Bermekimab Dose 1Experimental Treatment2 Interventions

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.

Group III: Part 2 (Group 2): Bermekimab Dose 1Experimental Treatment1 Intervention

Participants will receive bermekimab dose 1 SC at Week 0 and every week thereafter through Week 31.

Group IV: Part 1 (Group 3): Bermekimab Dose 1Experimental Treatment2 Interventions

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.

Group V: Part 1 (Group 2): AdalimumabActive Control2 Interventions

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.

Group VI: Part 2 (Group 1): PlaceboPlacebo Group2 Interventions

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.

Group VII: Part 1 (Group 1): PlaceboPlacebo Group2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

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