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ACTIVE NOT RECRUITING

NCT06881251

PHASE2

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

Official title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of JNJ-95475939 for the Treatment of Participants With Moderate to Severe AD

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

256

Start Date

2025-02-26

Completion Date

2026-03-26

Last Updated

2026-03-13

Healthy Volunteers

Conditions

Dermatitis, Atopic

Interventions

DRUG

Dupilumab

Dupilumab will be administered subcutaneously.

DRUG

JNJ-95475939

JNJ-95475939 will be administered subcutaneously.

DRUG

Placebo

Placebo will be administered subcutaneously.

Inclusion criteria: * 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 Exclusion criteria: * 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

Locations (71)

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

Studienzentrum an der Hase GbR

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (71)