A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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 Japan
Other trials for the same condition
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 Japan