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RECRUITING

NCT07230860

PHASE2

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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).

Official title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants With Moderate to Severe Atopic Dermatitis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-01-20

Completion Date

2028-02-10

Last Updated

2026-05-08

Healthy Volunteers

Conditions

Dermatitis, Atopic

Interventions

DRUG

JNJ-95597528

JNJ-95597528 will be administered subcutaneously.

DRUG

Placebo

Placebo will be administered subcutaneously.

Inclusion criteria: * Be otherwise healthy on the basis of physical examination, medical history, vital signs, 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 of symptoms 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 \>= 3 at screening and Week 0; d. \>= 10% body surface area (BSA) of AD involvement at screening and Week 0; e. Documented history (within 6 months before screening) of either inadequate response or inadvisability to medicated topical treatments for AD or inadequate response to systemic therapies (within 12 months before screening) * Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study * If willing to participate in the substudy, must sign a separate ICF for the corresponding substudy (or substudies) * Willing and able to comply with scheduled visits, treatment plan, laboratory tests, lifestyle restrictions, and other study procedures 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-lead ECG, chemistry, hematology, or urinalysis laboratory tests obtained at the screening visit that would affect interpretation of study data or the participant's safety in the study * Known or suspected immunodeficiency, including history of invasive opportunistic infections * Previously received JNJ-95597528 * Has known hypersensitivity or intolerance to JNJ-95597528 or its excipients or to any biologic medication or known allergies, or clinically significant reactions to murine, chimeric, monoclonal antibodies (mAbs), or antibody fragments

Locations (56)

First OC Dermatology

Fountain Valley, California, United States

Southern California Dermatology

Santa Ana, California, United States

Driven Research LLC

Coral Gables, Florida, United States

Arlington Dermatology

Rolling Meadows, Illinois, United States

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States

Henry Ford Health System

Detroit, Michigan, United States

Red River Research Partners LLC

Fargo, North Dakota, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

Clinical Research Philadelphia

Philadelphia, Pennsylvania, United States

Center for Clinical Studies

Houston, Texas, United States

Progressive Clinical Research

San Antonio, Texas, United States

Instituto Medico De Alta Complejidad (IMAC)

Buenos Aires, Argentina

CIPREC

Buenos Aires, Argentina

DOM Reumatología

Buenos Aires, Argentina

INAER - Investigación en Alergias y Enfermedades Respiratorias

Buenos Aires, Argentina

Derma Internacional S A

Buenos Aires, Argentina

Mautalen Salud e Investigacion

CABA, Argentina

Instituto de Investigaciones Clinicas Cordoba

Córdoba, Argentina

Centro de Investigaciones Clinicas CIC IESR

Rosario, Argentina

Centro Respiratorio Infantil

Rosario, Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Argentina

Ceti - Centro de Estudos Em Terapias Inovadoras

Curitiba, Brazil

Hospital De Clinicas De Porto Alegre

Porto Alegre, Brazil

Instituto Brasil de Pesquisa Clinica

Rio de Janeiro, Brazil

Fundacao do ABC Centro Universitario FMABC

Santo André, Brazil

Pesquisare Saude

Santo André, Brazil

PSEG trials Centro de Pesquisa Clinica S A

São Paulo, Brazil

Dermatology Research Institute Inc

Calgary, Alberta, Canada

CCA Medical Research Corporation

Ajax, Ontario, Canada

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, Canada

Dr Wei Jing Loo Medicine Professional Corporation

London, Ontario, Canada

DermEdge Research

Mississauga, Ontario, Canada

Allergy Research Canada Inc.

Niagara Falls, Ontario, Canada

York Dermatology Clinic and Research Centre

Richmond Hill, Ontario, Canada

XLR8 Medical Research

Windsor, Ontario, Canada

China Japan Friendship Hospital

Beijing, China

Xiangya Hospital Central South University

Changsha, China

Hosp. of Chengde Medical University

Chengde, China

West China Hospital of Sichuan University

Chengdu, China

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China

Sanmenxia Central Hospital

Sanmenxia, China

Wuxi People s Hospital

Wuxi, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Miyata Dermatology Clinic

Matsudo, Japan

Kume Clinic

Nishiku, Japan

Kindai University Hospital

Sakai, Japan

Teikyo University Hospital

tabashi City, Japan

Jitaikai Tachikawa dermatology clinic

Tachikawa, Japan

Nomura Dermatology Clinic

Yokohama, Japan

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital

Taoyuan, Taiwan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (56)