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

Last updated: June 2, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Terminated

Phase

2

Condition

Allergy

Rash

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: 256
Treatment Group(s): 3
Primary Treatment: Dupilumab
Phase: 2
Study Start date:
February 26, 2025
Estimated Completion Date:
April 07, 2026

Connect with a study center

  • CIPREC

    Buenos Aires, C1061AAS
    Argentina

    Site Not Available

  • Derma Internacional S A

    Buenos Aires, C1426
    Argentina

    Site Not Available

  • INAER - Investigación en Alergias y Enfermedades Respiratorias

    Buenos Aires, C1425
    Argentina

    Site Not Available

  • Instituto de Neumonologia y Dermatologia

    Buenos Aires, C1425
    Argentina

    Site Not Available

  • CIPREC

    Buenos Aires 3435910, C1061AAS
    Argentina

    Site Not Available

  • Derma Internacional S A

    Buenos Aires 3435910, C1426
    Argentina

    Site Not Available

  • Instituto de Neumonologia y Dermatologia

    Buenos Aires 3435910, C1425
    Argentina

    Site Not Available

  • Ceti - Centro de Estudos Em Terapias Inovadoras

    Curitiba, 80.030-110
    Brazil

    Site Not Available

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035 903
    Brazil

    Site Not Available

  • Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

    Ribeirão Preto, 14048 900
    Brazil

    Site Not Available

  • Instituto Brasil de Pesquisa Clinica

    Rio de Janeiro, 20241 180
    Brazil

    Site Not Available

  • Fundacao do ABC Centro Universitario FMABC

    Santo André, 09060 870
    Brazil

    Site Not Available

  • BR TRIALS Ensaios Clinicos e Consultoria Ltda

    São Paulo, 01236030
    Brazil

    Site Not Available

  • Dermatology Research Institute Inc

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Dr. Chih ho Hong Medical

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Karma Clinical Trials Inc.

    St. John's, Newfoundland and Labrador A1A 4Y3
    Canada

    Site Not Available

  • SimcoDerm Medical and Surgical Dermatology Centre

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Lynderm Research Inc.

    Markham, Ontario L3P 1X2
    Canada

    Site Not Available

  • Innovaderm Research Inc.

    Montreal, Quebec H2X 2V1
    Canada

    Site Not Available

  • Centre De Recherche Dermatologique Du Quebec Metropolitain

    Québec, Quebec G1V 4X7
    Canada

    Site Not Available

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455
    Germany

    Site Not Available

  • Charite - Universitaetsmedizin Berlin (CCM)

    Berlin, 10117
    Germany

    Site Not Available

  • ISA - Interdisciplinary Study Association GmbH

    Berlin, 10789
    Germany

    Site Not Available

  • ISA - Interdisciplinary Study Association GmbH

    Berlin 2950159, 10789
    Germany

    Site Not Available

  • Studienzentrum an der Hase GbR

    Bramsche, 49565
    Germany

    Site Not Available

  • Hautarztpraxis

    Bramsche 2945474, 49565
    Germany

    Site Not Available

  • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt

    Frankfurt, 60596
    Germany

    Site Not Available

  • Eurofins bioskin GmbH

    Hamburg, 20095
    Germany

    Site Not Available

  • Studienzentrum Dr Schwarz Germany

    Langenau, 89129
    Germany

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka, 814-0180
    Japan

    Site Not Available

  • Osaka Habikino Medical Center

    Habikino, 583 8588
    Japan

    Site Not Available

  • Teikyo University Hospital

    Itabashi Ku, 173 8606
    Japan

    Site Not Available

  • Kume Clinic

    Sakai, 593 8324
    Japan

    Site Not Available

  • Sapporo Skin Clinic

    Sapporo, 060 0063
    Japan

    Site Not Available

  • Jitaikai Tachikawa dermatology clinic

    Tachikawa, 190 0023
    Japan

    Site Not Available

  • Shirasaki Dermatology Clinic

    Takaoka Shi, 933-0871
    Japan

    Site Not Available

  • Mie University Hospital

    Tsu, 514-8507
    Japan

    Site Not Available

  • Nomura Dermatology Clinic

    Yokohama, 221 0825
    Japan

    Site Not Available

  • Queens Square Medical Facilities

    Yokohama, 220 6208
    Japan

    Site Not Available

  • Nomura Dermatology Clinic

    Yokohama 1848354, 221 0825
    Japan

    Site Not Available

  • Centrum Badan Klinicznych PI House sp z o o

    Gdansk, 80 546
    Poland

    Site Not Available

  • Care Clinic

    Katowice, 40 568
    Poland

    Site Not Available

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611
    Poland

    Site Not Available

  • Care Clinic

    Katowice 3096472, 40 568
    Poland

    Site Not Available

  • Centrum Medyczne All Med

    Krakow, 30 033
    Poland

    Site Not Available

  • Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna

    Krakow, 30-002
    Poland

    Site Not Available

  • Centrum Medyczne All Med

    Krakow 3094802, 30 033
    Poland

    Site Not Available

  • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

    Lodz, 90-338
    Poland

    Site Not Available

  • Klinika Ambroziak Dermatologia

    Warsaw, 02 953
    Poland

    Site Not Available

  • Royalderm Agnieszka Nawrocka

    Warsaw, 02962
    Poland

    Site Not Available

  • Therapia Nova

    Warsaw, 01 595
    Poland

    Site Not Available

  • Klinika Ambroziak Dermatologia

    Warsaw 756135, 02 953
    Poland

    Site Not Available

  • Royalderm Agnieszka Nawrocka

    Warsaw 756135, 02962
    Poland

    Site Not Available

  • Klinika Ambroziak Dermatologia

    Warszawa, 02 953
    Poland

    Active - Recruiting

  • Therapia Nova

    Warszawa, 01 595
    Poland

    Active - Recruiting

  • WroMedica I Bielicka A Strzalkowska s c

    Wroclaw, 51 685
    Poland

    Site Not Available

  • Hosp. Gral. Univ. Dr. Balmis

    Alicante, 03010
    Spain

    Site Not Available

  • Hosp. Univ. San Cecilio

    Granada, 18016
    Spain

    Site Not Available

  • Hosp. Univ. de Bellvitge

    LHospitalet de Llobregat, 08907
    Spain

    Site Not Available

  • Grupo Dermatologico Y Estetico Pedro Jaen

    Madrid, 28002
    Spain

    Site Not Available

  • Hosp. Univ. de La Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Grupo Dermatologico Y Estetico Pedro Jaen

    Madrid 3117735, 28006
    Spain

    Site Not Available

  • Hosp. Univ. de La Princesa

    Madrid 3117735, 28006
    Spain

    Site Not Available

  • Hosp. de Manises

    Manises, 46940
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust

    Kings Lynn, PE30 4ET
    United Kingdom

    Site Not Available

  • Guys and St Thomas NHS Foundation Trust

    London, SE1 9RT
    United Kingdom

    Site Not Available

  • Northwick Park Hospital

    London, HA13UJ
    United Kingdom

    Site Not Available

  • Royal London Hospital

    London, E1 1BB
    United Kingdom

    Site Not Available

  • Guys and St Thomas NHS Foundation Trust

    London 2643743, SE1 9RT
    United Kingdom

    Site Not Available

  • Royal London Hospital

    London 2643743, E1 1BB
    United Kingdom

    Site Not Available

  • Salford Royal Hospital

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • First OC Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • University of California Los Angeles - Division of Dermatology

    Los Angeles, California 90024
    United States

    Site Not Available

  • Hamilton Research LLC

    Alpharetta, Georgia 30022
    United States

    Site Not Available

  • DeNova Research

    Chicago, Illinois 60602
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group LLC

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Indiana Clinical Trial Center

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Red River Research Partners LLC

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Optima Research

    Boardman, Ohio 44512
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland, Oregon 97201
    United States

    Site Not Available

  • Arlington Center for Dermatology

    Arlington, Texas 76011
    United States

    Site Not Available

  • Center for Clinical Studies

    Houston, Texas 77004
    United States

    Site Not Available

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Frontier Derm Partners CRO, LLC

    Mill Creek, Washington 98012
    United States

    Site Not Available

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