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)
Proportion of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12 — Week 12 EASI-75 response is defined as at least 75 percent (%) improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness \[induration, papulation, edema\], scratching \[excoriation\], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD.
Trial sites (62)
Facility
City
Region
Status
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
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.
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