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

Last updated: May 7, 2026
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Dermatitis, Atopic

Treatment

JNJ-95597528

Placebo

Clinical Study ID

NCT07230860
95597528ADM2001
95597528ADM2001
2025-523464-20-00
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Be otherwise healthy on the basis of physical examination, medical history, vitalsigns, and 12-lead electrocardiogram (ECG) performed at screening

  • Meets all the following disease activity criteria: a. Chronic atopic dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset ofsymptoms at least 1 year prior to screening visit; b. Eczema area and severity index (EASI) score greater than or equal to (>=) 16 at the screening and Week 0; c.validated investigator global assessment for atopic dermatitis (vIGA-AD) score >= 3at screening and Week 0; d. >= 10% body surface area (BSA) of AD involvement atscreening and Week 0; e. Documented history (within 6 months before screening) ofeither inadequate response or inadvisability to medicated topical treatments for ADor inadequate response to systemic therapies (within 12 months before screening)

  • Must sign an informed consent form (ICF) indicating that the participant understandsthe purpose of, and procedures required for, the study and is willing to participatein the study

  • If willing to participate in the substudy, must sign a separate ICF for thecorresponding substudy (or substudies)

  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests,lifestyle restrictions, and other study procedures

Exclusion

Exclusion criteria:

  • History of substance abuse or alcohol abuse within 1 year before screening

  • In the investigator's opinion, any clinically significant results from the 12-leadECG, chemistry, hematology, or urinalysis laboratory tests obtained at the screeningvisit that would affect interpretation of study data or the participant's safety inthe study

  • Known or suspected immunodeficiency, including history of invasive opportunisticinfections

  • Previously received JNJ-95597528

  • Has known hypersensitivity or intolerance to JNJ-95597528 or its excipients or toany biologic medication or known allergies, or clinically significant reactions tomurine, chimeric, monoclonal antibodies (mAbs), or antibody fragments

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: JNJ-95597528
Phase: 2
Study Start date:
January 20, 2026
Estimated Completion Date:
February 10, 2028

Connect with a study center

  • CIPREC

    Buenos Aires, C1061AAS
    Argentina

    Active - Recruiting

  • DOM Reumatología

    Buenos Aires, C1111
    Argentina

    Active - Recruiting

  • Derma Internacional S A

    Buenos Aires, C1426
    Argentina

    Active - Recruiting

  • INAER - Investigación en Alergias y Enfermedades Respiratorias

    Buenos Aires, C1425BEN
    Argentina

    Active - Recruiting

  • Instituto Medico De Alta Complejidad (IMAC)

    Buenos Aires, B1643CRO
    Argentina

    Active - Recruiting

  • Mautalen Salud e Investigacion

    CABA, C1128AAF
    Argentina

    Active - Recruiting

  • Instituto de Investigaciones Clinicas Cordoba

    Córdoba, X5000AAW
    Argentina

    Active - Recruiting

  • Centro Respiratorio Infantil

    Rosario, 2000
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Clinicas CIC IESR

    Rosario, 2000
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, T4000AXL
    Argentina

    Active - Recruiting

  • Ceti - Centro de Estudos Em Terapias Inovadoras

    Curitiba, 80030 110
    Brazil

    Active - Recruiting

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035 903
    Brazil

    Active - Recruiting

  • Instituto Brasil de Pesquisa Clinica

    Rio de Janeiro, 20241 180
    Brazil

    Active - Recruiting

  • Fundacao do ABC Centro Universitario FMABC

    Santo André, 09060 870
    Brazil

    Active - Recruiting

  • Pesquisare Saude

    Santo André, 09080-110
    Brazil

    Active - Recruiting

  • PSEG trials Centro de Pesquisa Clinica S A

    São Paulo, 04038 002
    Brazil

    Active - Recruiting

  • Dermatology Research Institute Inc

    Calgary, Alberta T2J 7E1
    Canada

    Active - Recruiting

  • CCA Medical Research Corporation

    Ajax, Ontario L1S7K8
    Canada

    Active - Recruiting

  • SimcoDerm Medical and Surgical Dermatology Centre

    Barrie, Ontario L4M 7G1
    Canada

    Active - Recruiting

  • Dr Wei Jing Loo Medicine Professional Corporation

    London, Ontario N6H 5L5
    Canada

    Active - Recruiting

  • DermEdge Research

    Mississauga, Ontario L4Y 4C5
    Canada

    Active - Recruiting

  • Allergy Research Canada Inc.

    Niagara Falls, Ontario L2H 1H5
    Canada

    Active - Recruiting

  • York Dermatology Clinic and Research Centre

    Richmond Hill, Ontario L4B1L1
    Canada

    Active - Recruiting

  • XLR8 Medical Research

    Windsor, Ontario N8T 1E6
    Canada

    Active - Recruiting

  • China Japan Friendship Hospital

    Beijing, 100029
    China

    Active - Recruiting

  • China Japan Friendship Hospital

    Beijing 1816670, 100029
    China

    Site Not Available

  • Xiangya Hospital Central South University

    Changsha, 410008
    China

    Active - Recruiting

  • Hosp. of Chengde Medical University

    Chengde, 067030
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, 610041
    China

    Active - Recruiting

  • The First Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, 510080
    China

    Active - Recruiting

  • Sanmenxia Central Hospital

    Sanmenxia, 472000
    China

    Active - Recruiting

  • Sanmenxia Central Hospital

    Sanmenxia 1796669, 472000
    China

    Site Not Available

  • Wuxi People s Hospital

    Wuxi, 214100
    China

    Active - Recruiting

  • Wuxi People s Hospital

    Wuxi 1790923, 214100
    China

    Site Not Available

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710004
    China

    Active - Recruiting

  • Miyata Dermatology Clinic

    Matsudo, 271-0092
    Japan

    Active - Recruiting

  • Kume Clinic

    Nishiku, 593-8324
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Sakai, 590 0197
    Japan

    Active - Recruiting

  • Jitaikai Tachikawa dermatology clinic

    Tachikawa, 190 0023
    Japan

    Active - Recruiting

  • Jitaikai Tachikawa dermatology clinic

    Tachikawa 11611487, 190 0023
    Japan

    Site Not Available

  • Nomura Dermatology Clinic

    Yokohama, 221 0825
    Japan

    Active - Recruiting

  • Nomura Dermatology Clinic

    Yokohama 1848354, 221 0825
    Japan

    Site Not Available

  • Teikyo University Hospital

    tabashi City, 173-8606
    Japan

    Active - Recruiting

  • Chang Gung Memorial Hospital

    Kaohsiung City, 833
    Taiwan

    Active - Recruiting

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital

    Kaohsiung City 1673820, 833
    Taiwan

    Site Not Available

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 235
    Taiwan

    Active - Recruiting

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City 12908892, 235
    Taiwan

    Site Not Available

  • Chung Shan Medical University Hospital

    Taichung, 40201
    Taiwan

    Active - Recruiting

  • Chung Shan Medical University Hospital

    Taichung 1668399, 40201
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10048
    Taiwan

    Active - Recruiting

  • Tri-Service Genaral Hospital

    Taipei, 114202
    Taiwan

    Active - Recruiting

  • Tri-Service General Hospital

    Taipei, 114202
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei 1668341, 10048
    Taiwan

    Active - Recruiting

  • Tri-Service Genaral Hospital

    Taipei 1668341, 114202
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Linkou Chang Gung Memorial Hospital

    Taoyuan District, 333
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital

    Taoyuan District 1667905, 333
    Taiwan

    Site Not Available

  • First OC Dermatology

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • Southern California Dermatology

    Santa Ana, California 92701
    United States

    Active - Recruiting

  • Driven Research LLC

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Arlington Dermatology

    Rolling Meadows, Illinois 60008
    United States

    Active - Recruiting

  • Arlington Dermatology

    Rolling Meadows 4908052, Illinois 4896861 60008
    United States

    Site Not Available

  • Dawes Fretzin Clinical Research Group

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • Henry Ford Health System

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Red River Research Partners LLC

    Fargo, North Dakota 58103
    United States

    Active - Recruiting

  • Red River Research Partners LLC

    Fargo 5059163, North Dakota 5690763 58103
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Active - Recruiting

  • Clinical Research Philadelphia

    Philadelphia, Pennsylvania 19114
    United States

    Active - Recruiting

  • Clinical Research Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19114
    United States

    Site Not Available

  • Center for Clinical Studies

    Houston, Texas 77004
    United States

    Active - Recruiting

  • Progressive Clinical Research

    San Antonio, Texas 78213
    United States

    Active - Recruiting

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