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

NCT06881251 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 95475939ADM20012024-517814-13-00
• Study Type: interventional
• Target: 256
• Locations: 9 countries
• Sites: 71

Brief 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.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12

  EASI-75 response is defined as at least 75 percent (%) improvement in EASI total score. EASI-75 response is defined as at least 75% improvement from baseline in EASI total score. The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration/papulation, excoriation and lichenification on 4 anatomic regions of the body: head/neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting a higher severity of AD.

  Baseline, Week 12

Secondary Outcomes (32)

• Percentage of Participants With EASI-90 Response at Week 12

  Baseline, Week 12

• Percentage of Participants With EASI-100 Response at Week 12

  Baseline, Week 12

• Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 and a Reduction From Baseline of Greater Than Equal to (>=) 2 Points at Week 12

  Baseline, Week 12

• Percentage of Participants Achieving vIGA-AD Score of 0 and a Reduction From Baseline of >= 2 Points at Week 12

  Baseline, Week 12

• Percent Change From Baseline in the EASI Total Score at Week 12

  Baseline, Week 12

Study Arms (5)

Group A: Dupilumab

ACTIVE COMPARATOR

Participants will receive Dupilumab dose regimen 1 subcutaneously through Week 22.

Drug: Dupilumab

Group B: JNJ-95475939

EXPERIMENTAL

Participants will receive JNJ-95475939 dose regimen 1 subcutaneously through Week 22.

Drug: JNJ-95475939

Group C: JNJ-95475939

EXPERIMENTAL

Participants will receive JNJ-95475939 dose regimen 2 subcutaneously through Week 22.

Drug: JNJ-95475939

Group D: JNJ-95475939

EXPERIMENTAL

Participants will receive JNJ-95475939 dose regimen 3 subcutaneously through Week 22.

Drug: JNJ-95475939

Group E: Placebo

PLACEBO COMPARATOR

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.

Drug: JNJ-95475939; Drug: Placebo

Interventions

Dupilumab DRUG

Dupilumab will be administered subcutaneously.

Group A: Dupilumab

JNJ-95475939 DRUG

JNJ-95475939 will be administered subcutaneously.

Group B: JNJ-95475939; Group C: JNJ-95475939; Group D: JNJ-95475939; Group E: Placebo

Placebo DRUG

Placebo will be administered subcutaneously.

Group E: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Atopic Dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset of symptoms at least 1 year prior to the screening visit
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (71)

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

University of California Los Angeles - Division of Dermatology

Los Angeles, California, 90024, United States

Location

Hamilton Research LLC

Alpharetta, Georgia, 30022, United States

Location

DeNova Research

Chicago, Illinois, 60602, United States

Location

Dawes Fretzin Clinical Research Group LLC

Indianapolis, Indiana, 46250, United States

Location

Indiana Clinical Trial Center

Plainfield, Indiana, 46168, United States

Location

Red River Research Partners LLC

Fargo, North Dakota, 58103, United States

Location

Optima Research

Boardman, Ohio, 44512, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97201, United States

Location

Arlington Center for Dermatology

Arlington, Texas, 76011, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Frontier Derm Partners CRO, LLC

Mill Creek, Washington, 98012, United States

Location

CIPREC

Buenos Aires, C1061AAS, Argentina

Location

INAER - Investigación en Alergias y Enfermedades Respiratorias

Buenos Aires, C1425, Argentina

Location

Instituto de Neumonologia y Dermatologia

Buenos Aires, C1425, Argentina

Location

Derma Internacional S A

Buenos Aires, C1426, Argentina

Location

Ceti - Centro de Estudos Em Terapias Inovadoras

Curitiba, 80.030-110, Brazil

Location

Hospital De Clinicas De Porto Alegre

Porto Alegre, 90035 903, Brazil

Location

Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP

Ribeirão Preto, 14048 900, Brazil

Location

Instituto Brasil de Pesquisa Clinica

Rio de Janeiro, 20241 180, Brazil

Location

Fundacao do ABC Centro Universitario FMABC

Santo André, 09060 870, Brazil

Location

BR TRIALS Ensaios Clinicos e Consultoria Ltda

São Paulo, 01236030, Brazil

Location

Dermatology Research Institute Inc

Calgary, Alberta, T2J 7E1, Canada

Location

Dr. Chih ho Hong Medical

Surrey, British Columbia, V3R 6A7, Canada

Location

Karma Clinical Trials Inc.

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

Location

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, L4M 7G1, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X2, Canada

Location

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

Location

Centre De Recherche Dermatologique Du Quebec Metropolitain

Québec, Quebec, G1V 4X7, Canada

Location

Fachklinik Bad Bentheim

Bad Bentheim, 48455, Germany

Location

Charite - Universitaetsmedizin Berlin (CCM)

Berlin, 10117, Germany

Location

ISA - Interdisciplinary Study Association GmbH

Berlin, 10789, Germany

Location

Studienzentrum an der Hase GbR

Bramsche, 49565, Germany

Location

Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden

Dresden, 01307, Germany

Location

Universitatsklinikum Dusseldorf

Düsseldorf, 40225, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt, 60596, Germany

Location

Eurofins bioskin GmbH

Hamburg, 20095, Germany

Location

Studienzentrum Dr Schwarz Germany

Langenau, 89129, Germany

Location

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

Location

Osaka Habikino Medical Center

Habikino, 583 8588, Japan

Location

Teikyo University Hospital

Itabashi Ku, 173 8606, Japan

Location

Kume Clinic

Sakai, 593 8324, Japan

Location

Sapporo Skin Clinic

Sapporo, 060 0063, Japan

Location

Jitaikai Tachikawa dermatology clinic

Tachikawa, 190 0023, Japan

Location

Shirasaki Dermatology Clinic

Takaoka Shi, 933-0871, Japan

Location

Mie University Hospital

Tsu, 514-8507, Japan

Location

Queens Square Medical Facilities

Yokohama, 220 6208, Japan

Location

Nomura Dermatology Clinic

Yokohama, 221 0825, Japan

Location

Centrum Badan Klinicznych PI House sp z o o

Gdansk, 80 546, Poland

Location

Care Clinic

Katowice, 40 568, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland

Location

Centrum Medyczne All Med

Krakow, 30 033, Poland

Location

Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna

Krakow, 30-002, Poland

Location

Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

Lodz, 90-338, Poland

Location

Therapia Nova

Warsaw, 01 595, Poland

Location

Klinika Ambroziak Dermatologia

Warsaw, 02 953, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, 02962, Poland

Location

WroMedica I Bielicka A Strzalkowska s c

Wroclaw, 51 685, Poland

Location

Hosp. Gral. Univ. Dr. Balmis

Alicante, 03010, Spain

Location

Hosp. Univ. San Cecilio

Granada, 18016, Spain

Location

Hosp. Univ. de Bellvitge

LHospitalet de Llobregat, 08907, Spain

Location

Grupo Dermatologico Y Estetico Pedro Jaen

Madrid, 28002, Spain

Location

Hosp. Univ. de La Princesa

Madrid, 28006, Spain

Location

Hosp. de Manises

Manises, 46940, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Location

The Queen Elizabeth Hospital King's Lynn NHS Foundation Trust

Kings Lynn, PE30 4ET, United Kingdom

Location

Royal London Hospital

London, E1 1BB, United Kingdom

Location

Northwick Park Hospital

London, HA13UJ, United Kingdom

Location

Guys and St Thomas NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Salford Royal Hospital

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: February 26, 2025
• Primary Completion: March 9, 2026
• Study Completion: March 26, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (5); JP (10); ES (7); US (13); PL (10); DE (9); AR (4); BR (6); CA (7)