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

Last updated: March 28, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Scalp Disorders

Eczema (Atopic Dermatitis - Pediatric)

Dermatitis, Atopic

Treatment

Dupilumab

JNJ-95475939

Placebo

Clinical Study ID

NCT06881251
95475939ADM2001
2024-517814-13-00
95475939ADM2001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Chronic Atopic Dermatitis (AD), according to American Academy of DermatologyConsensus Criteria with onset of symptoms at least 1 year prior to the screeningvisit

  • Eczema Area and Severity Index (EASI) score greater than and equal to (>=) 16 at thescreening and baseline visits

  • Validated investigator global assessment for AD (vIGA-AD) score >= 3 at thescreening and baseline visits

  • >= 10% body surface area (BSA) of AD involvement at the screening and baselinevisits

  • Baseline Peak Pruritus Numeric(al) Rating Scale (PP-NRS) average score of >=4

  • Documented history (within 6 months before screening) of either inadequate responseor inadvisability to topical treatments, or inadequate response to systemictherapies (within 12 months before screening)

  • Participant has applied a moisturizer at least once daily for at least 7 days beforethe baseline visit

Exclusion

Exclusion criteria:

  • Experienced primary efficacy failure (no response within 16 weeks) or an adverseevent (AE) requiring discontinuation related to agents (eg, severe ocular surfacedisease, dupilumab-associated facial redness) inhibiting IL-4Rα, IL-4, and/or IL-13signaling (eg, dupilumab, lebrikizumab, or tralokinumab)

  • Participant is pregnant or breastfeeding, or planning to become pregnant orbreastfeed during the study

  • Active skin disease other than AD including eczema herpeticum, molluscumcontagiosum, impetigo, psoriasis or has any other ongoing significant skin conditionincluding skin infections, that, according to the investigator, could interfere withefficacy assessments

  • Current diagnosis or signs or symptoms of severe, progressive, or uncontrolledrenal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,hematologic, rheumatologic, psychiatric, or metabolic disturbances

  • Recent case of eczema herpeticum, herpes zoster within 8 weeks before screening, orhistory of recurrent eczema herpeticum

  • History of chronic or recurrent infectious disease, including but not limited tochronic renal infection, chronic chest infection (eg, untreated latenttuberculosis), recurrent urinary tract infection, fungal infection, mycobacterialinfection, or open, draining, or infected skin wounds, or ulcers.

  • Diagnosed active parasitic infection or at high risk of parasitic infection, unlesstreated with antihelminth therapy prior to randomization

  • Had major surgery (eg, requiring general anesthesia and hospitalization), within 8weeks before screening, or will not have fully recovered from surgery, or has suchsurgery planned during the time the participant is expected to participate in thestudy

Study Design

Total Participants: 240
Treatment Group(s): 3
Primary Treatment: Dupilumab
Phase: 2
Study Start date:
February 26, 2025
Estimated Completion Date:
July 15, 2026

Connect with a study center

  • Jitaikai Tachikawa dermatology clinic

    Tachikawa, 190 0023
    Japan

    Active - Recruiting

  • Shirasaki Dermatology Clinic

    Takaoka shi, 933-0871
    Japan

    Active - Recruiting

  • Queens Square Medical Facilities

    Yokohama, 220 6208
    Japan

    Active - Recruiting

  • First OC Dermatology

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Dawes Fretzin Clinical Research Group LLC

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Optima Research

    Boardman, Ohio 44512
    United States

    Active - Recruiting

  • Arlington Center for Dermatology

    Arlington, Texas 76011
    United States

    Active - Recruiting

  • Center for Clinical Studies

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Active - Recruiting

  • Frontier Derm Partners CRO, LLC

    Mill Creek, Washington 98012
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.