A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD)
NCT ID: NCT06881251
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
256 participants
INTERVENTIONAL
2025-02-26
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A: Dupilumab
Participants will receive Dupilumab dose regimen 1 subcutaneously through Week 22.
Dupilumab
Dupilumab will be administered subcutaneously.
Group B: JNJ-95475939
Participants will receive JNJ-95475939 dose regimen 1 subcutaneously through Week 22.
JNJ-95475939
JNJ-95475939 will be administered subcutaneously.
Group C: JNJ-95475939
Participants will receive JNJ-95475939 dose regimen 2 subcutaneously through Week 22.
JNJ-95475939
JNJ-95475939 will be administered subcutaneously.
Group D: JNJ-95475939
Participants will receive JNJ-95475939 dose regimen 3 subcutaneously through Week 22.
JNJ-95475939
JNJ-95475939 will be administered subcutaneously.
Group E: Placebo
Participants will receive matching placebo subcutaneously through Week 10, then switch to receive JNJ-95475939 dose regimen 1 subcutaneously between Week 12 and Week 22.
JNJ-95475939
JNJ-95475939 will be administered subcutaneously.
Placebo
Placebo will be administered subcutaneously.
Interventions
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Dupilumab
Dupilumab will be administered subcutaneously.
JNJ-95475939
JNJ-95475939 will be administered subcutaneously.
Placebo
Placebo will be administered subcutaneously.
Eligibility Criteria
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Inclusion Criteria
* Eczema Area and Severity Index (EASI) score greater than and equal to (\>=) 16 at the screening and baseline visits
* Validated investigator global assessment for AD (vIGA-AD) score \>= 3 at the screening and baseline visits
* \>= 10% body surface area (BSA) of AD involvement at the screening and baseline visits
* Baseline Peak Pruritus Numeric(al) Rating Scale (PP-NRS) average score of \>=4
* Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, or inadequate response to systemic therapies (within 12 months before screening)
* Participant has applied a moisturizer at least once daily for at least 7 days before the baseline visit
Exclusion Criteria
* Participant is pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study
* Active skin disease other than AD including eczema herpeticum, molluscum contagiosum, impetigo, psoriasis or has any other ongoing significant skin condition including skin infections, that, according to the investigator, could interfere with efficacy assessments
* Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
* Recent case of eczema herpeticum, herpes zoster within 8 weeks before screening, or history of recurrent eczema herpeticum
* History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, untreated latent tuberculosis), recurrent urinary tract infection, fungal infection, mycobacterial infection, or open, draining, or infected skin wounds, or ulcers.
* Diagnosed active parasitic infection or at high risk of parasitic infection, unless treated with antihelminth therapy prior to randomization
* Had major surgery (eg, requiring general anesthesia and hospitalization), within 8 weeks before screening, or will not have fully recovered from surgery, or has such surgery planned during the time the participant is expected to participate in the study
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Locations
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First OC Dermatology
Fountain Valley, California, United States
University of California Los Angeles - Division of Dermatology
Los Angeles, California, United States
Hamilton Research LLC
Alpharetta, Georgia, United States
DeNova Research
Chicago, Illinois, United States
Dawes Fretzin Clinical Research Group LLC
Indianapolis, Indiana, United States
Indiana Clinical Trial Center
Plainfield, Indiana, United States
Red River Research Partners LLC
Fargo, North Dakota, United States
Optima Research
Boardman, Ohio, United States
Oregon Medical Research Center
Portland, Oregon, United States
Arlington Center for Dermatology
Arlington, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Frontier Derm Partners CRO, LLC
Mill Creek, Washington, United States
CIPREC
Buenos Aires, , Argentina
INAER - Investigación en Alergias y Enfermedades Respiratorias
Buenos Aires, , Argentina
Instituto de Neumonologia y Dermatologia
Buenos Aires, , Argentina
Derma Internacional S A
Buenos Aires, , Argentina
Ceti - Centro de Estudos Em Terapias Inovadoras
Curitiba, , Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP
Ribeirão Preto, , Brazil
Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, , Brazil
Fundacao do ABC Centro Universitario FMABC
Santo André, , Brazil
BR TRIALS Ensaios Clinicos e Consultoria Ltda
São Paulo, , Brazil
Dermatology Research Institute Inc
Calgary, Alberta, Canada
Dr. Chih ho Hong Medical
Surrey, British Columbia, Canada
Karma Clinical Trials Inc.
St. John's, Newfoundland and Labrador, Canada
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Centre De Recherche Dermatologique Du Quebec Metropolitain
Québec, Quebec, Canada
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
Charite - Universitaetsmedizin Berlin (CCM)
Berlin, , Germany
ISA - Interdisciplinary Study Association GmbH
Berlin, , Germany
Hautarztpraxis
Bramsche, , Germany
Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
Dresden, , Germany
Universitatsklinikum Dusseldorf
Düsseldorf, , Germany
Universitatsklinikum Frankfurt
Frankfurt, , Germany
Eurofins bioskin GmbH
Hamburg, , Germany
Studienzentrum Dr Schwarz Germany
Langenau, , Germany
Fukuoka University Hospital
Fukuoka, , Japan
Osaka Habikino Medical Center
Habikino, , Japan
Teikyo University Hospital
Itabashi Ku, , Japan
Kume Clinic
Sakai, , Japan
Sapporo Skin Clinic
Sapporo, , Japan
Jitaikai Tachikawa dermatology clinic
Tachikawa, , Japan
Shirasaki Dermatology Clinic
Takaoka Shi, , Japan
Mie University Hospital
Tsu, , Japan
Queens Square Medical Facilities
Yokohama, , Japan
Nomura Dermatology Clinic
Yokohama, , Japan
Centrum Badan Klinicznych PI House sp z o o
Gdansk, , Poland
Care Clinic
Katowice, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
Centrum Medyczne All Med
Krakow, , Poland
Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
Krakow, , Poland
Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
Lodz, , Poland
Therapia Nova
Warsaw, , Poland
Klinika Ambroziak Dermatologia
Warsaw, , Poland
Royalderm Agnieszka Nawrocka
Warsaw, , Poland
WroMedica I Bielicka A Strzalkowska s c
Wroclaw, , Poland
Hosp. Gral. Univ. Dr. Balmis
Alicante, , Spain
Hosp. Univ. San Cecilio
Granada, , Spain
Hosp. Univ. de Bellvitge
LHospitalet de Llobregat, , Spain
Grupo Dermatologico Y Estetico Pedro Jaen
Madrid, , Spain
Hosp. Univ. de La Princesa
Madrid, , Spain
Hosp. de Manises
Manises, , Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, , Spain
The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust
Kings Lynn, , United Kingdom
Royal London Hospital
London, , United Kingdom
Northwick Park Hospital
London, , United Kingdom
Guys and St Thomas NHS Foundation Trust
London, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Countries
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Other Identifiers
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95475939ADM2001
Identifier Type: OTHER
Identifier Source: secondary_id
2024-517814-13-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
95475939ADM2001
Identifier Type: -
Identifier Source: org_study_id
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