A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT07230860
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Dermatitis, Atopic

Eligibility Criteria

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

Interventions

  • JNJ-95597528 — DRUG
    JNJ-95597528 will be administered subcutaneously.
  • Placebo — DRUG
    Placebo will be administered subcutaneously.

Study Details

The purpose of this study is to assess how well JNJ-95597528 works compared to placebo in participants with moderate to severe atopic dermatitis (AD).

Key Dates

Start date
Jan 20, 2026
Status verified
Jun 2026
Primary completion
Nov 19, 2026
Completion
Feb 10, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: JNJ-95597528 (Dose 1)
    Participants will receive JNJ-95597528 Dose 1 on Weeks 0, 2, 12, and 24.
  • Experimental: Group 2: JNJ-95597528 (Dose 2 and 3)
    Participants will receive JNJ-95597528 Dose 2 on Week 0 followed by JNJ-95597528 Dose 3 on Weeks 12, and 24.
  • Experimental: Group 3: JNJ-95597528 (Dose 4 and 5)
    Participants will receive JNJ-95597528 Dose 4 on Week 0 followed by JNJ-95597528 Dose 5 on Weeks 12, and 24.
  • Placebo Comparator: Group 4: Placebo and JNJ-95597528 (Dose 2 and 3)
    Participants will receive placebo from Weeks 0 to 12 , then switch to receive JNJ-95597528 Dose 2 administered at Week 12 followed by Dose 3 at Week 24.

Primary Outcome Measure

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

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
First OC DermatologyFountain ValleyCalifornia92708-
University of California Los Angeles - Division of DermatologyLos AngelesCalifornia90024-
Southern California DermatologySanta AnaCalifornia92701-
Driven Research LLCMiamiFlorida33126-
Arlington DermatologyRolling MeadowsIllinois60008-
Dawes Fretzin Clinical Research GroupIndianapolisIndiana46250-
Henry Ford Health SystemDetroitMichigan48202-
Red River Research Partners LLCFargoNorth Dakota58103-
Oregon Dermatology and Research CenterPortlandOregon97210-
Clinical Research PhiladelphiaPhiladelphiaPennsylvania19114-
Center for Clinical StudiesHoustonTexas77004-
Progressive Clinical ResearchSan AntonioTexas78213-

Find similar trials in Fountain Valley, CA

By research site
First OC Dermatology· Fountain Valley, CAUniversity of California Los Angeles - Division of Dermatology· Los Angeles, CASouthern California Dermatology· Santa Ana, CADriven Research LLC· Miami, FLArlington Dermatology· Rolling Meadows, ILDawes Fretzin Clinical Research Group· Indianapolis, IN

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