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

Last updated: September 11, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Dermatitis, Atopic

Rash

Allergy

Treatment

Placebo

JNJ-95475939

Dupilumab

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: Placebo
Phase: 2
Study Start date:
February 26, 2025
Estimated Completion Date:
August 14, 2026

Connect with a study center

  • Derma Internacional S A

    Buenos Aires, C1426
    Argentina

    Active - Recruiting

  • INAER - Investigación en Alergias y Enfermedades Respiratorias

    Buenos Aires, C1425
    Argentina

    Site Not Available

  • Instituto de Neumonologia y Dermatologia

    Buenos Aires, C1425
    Argentina

    Active - Recruiting

  • CIPREC

    Buenos Aires 3435910, C1061AAS
    Argentina

    Active - Recruiting

  • Derma Internacional S A

    Buenos Aires 3435910, C1426
    Argentina

    Active - Recruiting

  • INAER - Investigación en Alergias y Enfermedades Respiratorias

    Buenos Aires 3435910, C1425
    Argentina

    Active - Recruiting

  • Instituto de Neumonologia y Dermatologia

    Buenos Aires 3435910, C1425
    Argentina

    Active - Recruiting

  • CIPREC

    Ciudad Autonoma de Buenos Aires, C1061AAS
    Argentina

    Site Not Available

  • Ceti - Centro de Estudos Em Terapias Inovadoras

    Curitiba, 80.030-110
    Brazil

    Site Not Available

  • Ceti - Centro de Estudos Em Terapias Inovadoras

    Curitiba 3464975, 80.030-110
    Brazil

    Active - Recruiting

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035 903
    Brazil

    Site Not Available

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre 3452925, 90035 903
    Brazil

    Active - Recruiting

  • Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

    Ribeirao Preto, 14048 900
    Brazil

    Site Not Available

  • Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

    Ribeirão Preto 3451328, 14048 900
    Brazil

    Active - Recruiting

  • Instituto Brasil de Pesquisa Clinica

    Rio de Janeiro, 20241 180
    Brazil

    Site Not Available

  • Instituto Brasil de Pesquisa Clinica

    Rio de Janeiro 3451190, 20241 180
    Brazil

    Active - Recruiting

  • Fundacao do ABC Centro Universitario FMABC

    Santo Andre, 09060 870
    Brazil

    Site Not Available

  • Fundacao do ABC Centro Universitario FMABC

    Santo André 3449701, 09060 870
    Brazil

    Active - Recruiting

  • BR TRIALS Ensaios Clinicos e Consultoria Ltda

    Sao Paulo, 01236030
    Brazil

    Site Not Available

  • BR TRIALS Ensaios Clinicos e Consultoria Ltda

    São Paulo 3448439, 01236030
    Brazil

    Active - Recruiting

  • Dermatology Research Institute Inc

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Dermatology Research Institute Inc

    Calgary 5913490, Alberta 5883102 T2J 7E1
    Canada

    Active - Recruiting

  • Dr. Chih ho Hong Medical

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Dr. Chih ho Hong Medical

    Surrey 6159905, British Columbia 5909050 V3R 6A7
    Canada

    Active - Recruiting

  • Karma Clinical Trials Inc.

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

    Site Not Available

  • Karma Clinical Trials Inc.

    St. John's 6324733, Newfoundland and Labrador 6354959 A1A 4Y3
    Canada

    Active - Recruiting

  • 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

  • SimcoDerm Medical and Surgical Dermatology Centre

    Barrie 5894171, Ontario 6093943 L4M 7G1
    Canada

    Active - Recruiting

  • Lynderm Research Inc.

    Markham 6066513, Ontario 6093943 L3P 1X2
    Canada

    Active - Recruiting

  • Innovaderm Research Inc.

    Montreal, Quebec H2X 2V1
    Canada

    Site Not Available

  • Innovaderm Research Inc.

    Montreal 6077243, Quebec 6115047 H2X 2V1
    Canada

    Active - Recruiting

  • Centre De Recherche Dermatologique Du Quebec Metropolitain

    Québec 6325494, Quebec 6115047 G1V 4X7
    Canada

    Active - Recruiting

  • Centre De Recherche Dermatologique Du Quebec Metropolitain

    Quebec, G1V 4X7
    Canada

    Site Not Available

  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455
    Germany

    Site Not Available

  • Fachklinik Bad Bentheim

    Bad Bentheim 2953552, 48455
    Germany

    Active - Recruiting

  • Charite - Universitaetsmedizin Berlin (CCM)

    Berlin, 10117
    Germany

    Site Not Available

  • ISA - Interdisciplinary Study Association GmbH

    Berlin, 10789
    Germany

    Active - Recruiting

  • Charite - Universitaetsmedizin Berlin (CCM)

    Berlin 2950159, 10117
    Germany

    Active - Recruiting

  • ISA - Interdisciplinary Study Association GmbH

    Berlin 2950159, 10789
    Germany

    Active - Recruiting

  • Hautarztpraxis

    Bramsche, 49565
    Germany

    Site Not Available

  • Hautarztpraxis

    Bramsche 2945474, 49565
    Germany

    Active - Recruiting

  • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

    Dresden 2935022, 01307
    Germany

    Active - Recruiting

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Universitatsklinikum Dusseldorf

    Düsseldorf 2934246, 40225
    Germany

    Active - Recruiting

  • Universitatsklinikum Frankfurt

    Frankfurt, 60596
    Germany

    Site Not Available

  • Universitatsklinikum Frankfurt

    Frankfurt 2925536, 60596
    Germany

    Active - Recruiting

  • Eurofins bioskin GmbH

    Hamburg, 20095
    Germany

    Site Not Available

  • Eurofins bioskin GmbH

    Hamburg 2911298, 20095
    Germany

    Active - Recruiting

  • Studienzentrum Dr Schwarz Germany

    Langenau, 89129
    Germany

    Site Not Available

  • Studienzentrum Dr Schwarz Germany

    Langenau 2881259, 89129
    Germany

    Active - Recruiting

  • Fukuoka University Hospital

    Fukuoka 1863967, 814-0180
    Japan

    Active - Recruiting

  • Fukuoka University Hospital

    Fukuoka-shi, 814-0180
    Japan

    Site Not Available

  • Osaka Habikino Medical Center

    Habikino, 583 8588
    Japan

    Site Not Available

  • Osaka Habikino Medical Center

    Habikino 6825496, 583 8588
    Japan

    Active - Recruiting

  • Teikyo University Hospital

    Itabashi Ku, 173 8606
    Japan

    Active - Recruiting

  • Kume Clinic

    Sakai 1853195, 593 8324
    Japan

    Active - Recruiting

  • Kume Clinic

    Sakai City, 593 8324
    Japan

    Site Not Available

  • Sapporo Skin Clinic

    Sapporo 2128295, 060 0063
    Japan

    Active - Recruiting

  • Sapporo Skin Clinic

    Sapporo shi, 060 0063
    Japan

    Site Not Available

  • Jitaikai Tachikawa dermatology clinic

    Tachikawa, 190 0023
    Japan

    Site Not Available

  • Jitaikai Tachikawa dermatology clinic

    Tachikawa 11611487, 190 0023
    Japan

    Active - Recruiting

  • Shirasaki Dermatology Clinic

    Takaoka Shi, 933-0871
    Japan

    Active - Recruiting

  • Mie University Hospital

    Tsu, 514-8507
    Japan

    Site Not Available

  • Mie University Hospital

    Tsu 1849796, 514-8507
    Japan

    Active - Recruiting

  • Nomura Dermatology Clinic

    Yokohama, 221 0825
    Japan

    Site Not Available

  • Queens Square Medical Facilities

    Yokohama, 220 6208
    Japan

    Active - Recruiting

  • Nomura Dermatology Clinic

    Yokohama 1848354, 221 0825
    Japan

    Active - Recruiting

  • Queens Square Medical Facilities

    Yokohama 1848354, 220 6208
    Japan

    Active - Recruiting

  • Centrum Badan Klinicznych PI House sp z o o

    Gdansk, 80 546
    Poland

    Site Not Available

  • Centrum Badan Klinicznych PI House sp z o o

    Gdansk 3099434, 80 546
    Poland

    Active - Recruiting

  • Care Clinic

    Katowice, 40 568
    Poland

    Active - Recruiting

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611
    Poland

    Site Not Available

  • Care Clinic

    Katowice 3096472, 40 568
    Poland

    Active - Recruiting

  • Centrum Medyczne Angelius Provita

    Katowice 3096472, 40-611
    Poland

    Active - Recruiting

  • Centrum Medyczne All Med

    Krakow, 30 033
    Poland

    Active - Recruiting

  • 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

    Active - Recruiting

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

    Krakow 3094802, 30-002
    Poland

    Active - Recruiting

  • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

    Lodz, 90-338
    Poland

    Site Not Available

  • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

    Lodz 3093133, 90-338
    Poland

    Active - Recruiting

  • Klinika Ambroziak Dermatologia

    Warsaw 756135, 02 953
    Poland

    Active - Recruiting

  • Royalderm Agnieszka Nawrocka

    Warsaw 756135, 02962
    Poland

    Active - Recruiting

  • Therapia Nova

    Warsaw 756135, 01 595
    Poland

    Active - Recruiting

  • Klinika Ambroziak Dermatologia

    Warszawa, 02 953
    Poland

    Active - Recruiting

  • Royalderm Agnieszka Nawrocka

    Warszawa, 02962
    Poland

    Site Not Available

  • Therapia Nova

    Warszawa, 01 595
    Poland

    Active - Recruiting

  • WroMedica I Bielicka A Strzalkowska s c

    Wroclaw, 51 685
    Poland

    Site Not Available

  • WroMedica I Bielicka A Strzalkowska s c

    Wroclaw 3081368, 51 685
    Poland

    Active - Recruiting

  • Hosp. Gral. Univ. Dr. Balmis

    Alicante, 03010
    Spain

    Site Not Available

  • Hosp. Gral. Univ. Dr. Balmis

    Alicante 2521978, 03010
    Spain

    Active - Recruiting

  • Hosp. Univ. San Cecilio

    Granada, 18016
    Spain

    Site Not Available

  • Hosp. Univ. San Cecilio

    Granada 2517117, 18016
    Spain

    Active - Recruiting

  • Hosp. Univ. de Bellvitge

    LHospitalet de Llobregat, 08907
    Spain

    Active - Recruiting

  • Grupo Dermatologico Y Estetico Pedro Jaen

    Madrid, 28006
    Spain

    Site Not Available

  • Hosp. Univ. de La Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Grupo Dermatologico Y Estetico Pedro Jaen

    Madrid 3117735, 28006
    Spain

    Active - Recruiting

  • Hosp. Univ. de La Princesa

    Madrid 3117735, 28006
    Spain

    Active - Recruiting

  • Hosp. de Manises

    Manises, 46940
    Spain

    Site Not Available

  • Hosp. de Manises

    Manises 2514197, 46940
    Spain

    Active - Recruiting

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706
    Spain

    Site Not Available

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela 3109642, 15706
    Spain

    Active - Recruiting

  • Guys and St Thomas NHS Foundation Trust

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Northwick Park Hospital

    London, HA13UJ
    United Kingdom

    Active - Recruiting

  • Royal London Hospital

    London, E1 1BB
    United Kingdom

    Site Not Available

  • Guys and St Thomas NHS Foundation Trust

    London 2643743, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Northwick Park Hospital

    London 2643743, HA13UJ
    United Kingdom

    Active - Recruiting

  • Royal London Hospital

    London 2643743, E1 1BB
    United Kingdom

    Active - Recruiting

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

    Norfolk, PE30 4ET
    United Kingdom

    Active - Recruiting

  • Salford Royal Hospital

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Salford Royal Hospital

    Salford 2638671, M6 8HD
    United Kingdom

    Active - Recruiting

  • 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

  • First OC Dermatology

    Fountain Valley 5350207, California 5332921 92708
    United States

    Active - Recruiting

  • University of California Los Angeles - Division of Dermatology

    Los Angeles 5368361, California 5332921 90024
    United States

    Active - Recruiting

  • Hamilton Research LLC

    Alpharetta, Georgia 30022
    United States

    Site Not Available

  • Hamilton Research LLC

    Alpharetta 4179574, Georgia 4197000 30022
    United States

    Active - Recruiting

  • DeNova Research

    Chicago, Illinois 60602
    United States

    Site Not Available

  • DeNova Research

    Chicago 4887398, Illinois 4896861 60602
    United States

    Active - Recruiting

  • 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

  • Dawes Fretzin Clinical Research Group LLC

    Indianapolis 4259418, Indiana 4921868 46250
    United States

    Active - Recruiting

  • Indiana Clinical Trial Center

    Plainfield 4263108, Indiana 4921868 46168
    United States

    Active - Recruiting

  • Red River Research Partners LLC

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Red River Research Partners LLC

    Fargo 5059163, North Dakota 5690763 58103
    United States

    Active - Recruiting

  • Optima Research

    Boardman, Ohio 44512
    United States

    Site Not Available

  • Optima Research

    Boardman 5147784, Ohio 5165418 44512
    United States

    Active - Recruiting

  • Oregon Medical Research Center

    Portland, Oregon 97201
    United States

    Site Not Available

  • Oregon Medical Research Center

    Portland 5746545, Oregon 5744337 97201
    United States

    Active - Recruiting

  • 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

  • Arlington Center for Dermatology

    Arlington 4671240, Texas 4736286 76011
    United States

    Active - Recruiting

  • Center for Clinical Studies

    Houston 4699066, Texas 4736286 77004
    United States

    Active - Recruiting

  • Progressive Clinical Research

    San Antonio 4726206, Texas 4736286 78213
    United States

    Active - Recruiting

  • Frontier Derm Partners CRO, LLC

    Mill Creek, Washington 98012
    United States

    Site Not Available

  • Frontier Derm Partners CRO, LLC

    Mill Creek 5803457, Washington 5815135 98012
    United States

    Active - Recruiting

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