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Clinical Trials in the USA / NCT07230860
Active, not recruiting Phase 2

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

NCT07230860 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 2
Started
2026-01-20
Last updated
2026-08-28

Condition(s) studied

Dermatitis, Atopic

Investigational drug(s) / intervention(s)

JNJ-95597528Placebo

JNJ-95597528: JNJ-95597528 will be administered subcutaneously.

Placebo: Placebo will be administered subcutaneously.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (62)

FacilityCityRegionStatus
First OC Dermatology Fountain Valley California
University of California Los Angeles - Division of Dermatology Los Angeles California
Southern California Dermatology Santa Ana California
Driven Research LLC Miami Florida
Arlington Dermatology Rolling Meadows Illinois
Dawes Fretzin Clinical Research Group Indianapolis Indiana
Henry Ford Health System Detroit Michigan
Red River Research Partners LLC Fargo North Dakota
Oregon Dermatology and Research Center Portland Oregon
Clinical Research Philadelphia Philadelphia Pennsylvania
Center for Clinical Studies Houston Texas
Progressive Clinical Research San Antonio Texas
Instituto Medico De Alta Complejidad (IMAC) Buenos Aires Argentina
CIPREC Buenos Aires Argentina
DOM Reumatologia Buenos Aires Argentina
INAER - Investigacion 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
Pesquisare Saude Santo André Brazil
PSEG trials Centro de Pesquisa Clinica S A São Paulo Brazil
Cepes - Fmabc São Paulo Brazil
Dermatology Research Institute Inc Calgary Alberta
CCA Medical Research Corporation Ajax Ontario
SimcoDerm Medical and Surgical Dermatology Centre Barrie Ontario
Dr Wei Jing Loo Medicine Professional Corporation London Ontario
DermEdge Research Mississauga Ontario
Allergy Research Canada Inc. Niagara Falls Ontario
York Dermatology Clinic and Research Centre Richmond Hill Ontario
XLR8 Medical Research Windsor Ontario
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

+ 22 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07230860 on ClinicalTrials.gov ↗ ← All trials in the USA