A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD)

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06881251
Phase
PHASE2
Status
Terminated

Conditions

  • Dermatitis, Atopic

Eligibility Criteria

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

Interventions

  • Dupilumab — DRUG
    Dupilumab will be administered subcutaneously.
  • JNJ-95475939 — DRUG
    JNJ-95475939 will be administered subcutaneously.
  • Placebo — DRUG
    Placebo will be administered subcutaneously.

Study Details

The purpose of this study is to evaluate how well JNJ-95475939 works as compared to placebo in participants with moderate to severe atopic dermatitis.

Key Dates

Start date
Feb 26, 2025
Status verified
Jun 2026
Primary completion
Mar 26, 2026
Completion
Apr 7, 2026

Study Design

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

Arms

  • Active Comparator: Group A: Dupilumab
    Participants will receive Dupilumab dose regimen 1 subcutaneously through Week 22.
  • Experimental: Group B: JNJ-95475939
    Participants will receive JNJ-95475939 dose regimen 1 subcutaneously through Week 22.
  • Experimental: Group C: JNJ-95475939
    Participants will receive JNJ-95475939 dose regimen 2 subcutaneously through Week 22.
  • Experimental: Group D: JNJ-95475939
    Participants will receive JNJ-95475939 dose regimen 3 subcutaneously through Week 22.
  • Placebo Comparator: Group E: Placebo
    Participants will receive matching placebo subcutaneously through Week 10, then switch to receive JNJ-95475939 dose regimen 1 subcutaneously between Week 12 and Week 22.

Primary Outcome Measure

Percentage of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12 [ Time Frame: Baseline, Week 12 ]

Locations (13)

FacilityCityStateZIPSite coordinators
First OC DermatologyFountain ValleyCalifornia92708-
University of California Los Angeles - Division of DermatologyLos AngelesCalifornia90024-
Hamilton Research LLCAlpharettaGeorgia30022-
DeNova ResearchChicagoIllinois60602-
Dawes Fretzin Clinical Research Group LLCIndianapolisIndiana46250-
Indiana Clinical Trial CenterPlainfieldIndiana46168-
Red River Research Partners LLCFargoNorth Dakota58103-
Optima ResearchBoardmanOhio44512-
Oregon Medical Research CenterPortlandOregon97201-
Arlington Center for DermatologyArlingtonTexas76011-
Center for Clinical StudiesHoustonTexas77004-
Progressive Clinical ResearchSan AntonioTexas78213-
Frontier Derm Partners CRO, LLCMill CreekWashington98012-

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