A Study of Bermekimab (JNJ-77474462) in the Treatment of Participants With Moderate to Severe Atopic Dermatitis

Part of paid clinical trials in Los Angeles, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04791319
Phase
PHASE2
Status
Terminated

Conditions

  • Dermatitis, Atopic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

The purpose of this study is to evaluate the efficacy and safety of bermekimab in participants with moderate to severe atopic dermatitis (AD).

Key Dates

Start date
May 3, 2021
Status verified
Feb 2023
Primary completion
Feb 2, 2022
Completion
Mar 31, 2022

Study Design

Enrollment
199 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Group 1: Placebo
    Participants will receive subcutaneous (SC) placebo once a week (qw) through Week 15. At Week 16, participants will crossover to receive SC bermekimab Dose 2 qw through Week 31.
  • Experimental: Group 2: Bermekimab
    Participant will receive SC bermekimab Dose 1 qw from Week 0 through Week 31.
  • Experimental: Group 3: Bermekimab
    Participants will receive SC bermekimab Dose 2 qw from Week 0 through Week 15. At Week 16, participants who achieve an eczema area and severity index (EASI)-75 response (responders) will be rerandomized either to continue to receive bermekimab Dose 2 qw, or to receive bermekimab Dose 1 qw, through Week 31 and participants who do not achieve an EASI-75 response (non responders) will continue to receive bermekimab Dose 2 qw through Week 31.
  • Active Comparator: Group 4: Dupilumab
    Participants will receive a loading dose of SC dupilumab Dose 1 at Week 0, SC placebo every two week (q2w) from Week 1 through Week 15 and then dupilumab Dose 2 q2w from Week 2 through Week 14. At Week 16, participants who achieve EASI-75 response (dupilumab responders) will continue on dupilumab Dose 2 q2w through Week 30 and placebo q2w from Week 17 through Week 31. Participants who do not achieve an EASI-75 response (dupilumab non-responders) will receive placebo qw from Week 16 through Week 18 (washout period) and bermekimab Dose 2 qw from Week 19 through Week 31.

Primary Outcome Measure

Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (Greater Than or Equal to [>=] 75 Percent [%] Improvement From Baseline) at Week 16 [ Time Frame: Week 16 ]

Locations (18)

FacilityCityStateZIPSite coordinators
California Allergy & Asthma Medical Group Inc.Los AngelesCalifornia90025-
Wolverine Clinical TrialsSanta AnaCalifornia92705-
Park Avenue DermatologyOrange ParkFlorida32073-
Forcare Clinical Research, Inc.TampaFlorida33613-
Arlington DermatologyRolling MeadowsIllinois60008-
Dawes Fretzin Clinical Research GroupIndianapolisIndiana46256-
Grekin Skin InstituteWarrenMichigan48088-
Psoriasis Treatment Center of Central New JerseyEast WindsorNew Jersey08520-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Ohio State UniversityColumbusOhio43215-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
Clinical PartnersJohnstonRhode Island02919-
Arlington Center for DermatologyArlingtonTexas76011-
Austin Institute for Clinical ResearchPflugervilleTexas78660-
Progressive Clinical ResearchSan AntonioTexas78213-
Center for Clinical StudiesWebsterTexas77598-
Virginia Clinical ResearchNorfolkVirginia23502-
Premier Clinical ResearchSpokaneWashington99202-

Find similar trials in Los Angeles, CA

By research site
California Allergy & Asthma Medical Group Inc.· Los Angeles, CAWolverine Clinical Trials· Santa Ana, CAPark Avenue Dermatology· Orange Park, FLForcare Clinical Research, Inc.· Tampa, FLArlington Dermatology· Rolling Meadows, ILDawes Fretzin Clinical Research Group· Indianapolis, IN

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