NCT07230860Active, not recruitingPhase 2
A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 189 (actual)
- First submitted
- 14 Nov 2025
- Start date
- 20 Jan 2026
- Primary completion date
- 19 Nov 2026
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07230860
- EU CT number
- 2025-523464-20-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 189
- From 20 Jan 2026 to the primary completion date, 19 Nov 2026
- 67 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously received JNJ-95597528
Other illness
- History of substance abuse or alcohol abuse within 1 year before screening
- Known or suspected immunodeficiency, including history of invasive opportunistic infections
- 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
Lab values
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (67)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CIPREC Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Instituto Medico De Alta Complejidad (IMAC) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Derma Internacional S A Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| DOM Reumatologia Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| INAER - Investigacion en Alergias y Enfermedades Respiratorias Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Mautalen- Salud e Investigacion Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Instituto de Investigaciones Clínicas Córdoba Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Centro de Investigaciones Clinicas CIC IESR Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Centro Respiratorio Infantil Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| Centro de Investigaciones Medicas Tucuman Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Ceti - Centro de Estudos Em Terapias Inovadoras Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Instituto Brasil de Pesquisa Clinica Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Pesquisare Saude Coordinator of this site? Confirm its status | Santo André | Brazil | Unknown status |
| Cepes - Fmabc Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| PSEG trials Centro de Pesquisa Clinica S A Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CCA Medical Research Corporation Coordinator of this site? Confirm its status | Ajax | Canada | Unknown status |
| Simcoderm Medical and Surgical Dermatology Centre Coordinator of this site? Confirm its status | Barrie | Canada | Unknown status |
| Dermatology Research Institute Inc Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Dr Wei Jing Loo Medicine Professional Corporation Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| DermEdge Research Coordinator of this site? Confirm its status | Mississauga | Canada | Unknown status |
| Allergy Research Canada Inc. Coordinator of this site? Confirm its status | Niagara Falls | Canada | Unknown status |
| York Dermatology Clinic and Research Centre Coordinator of this site? Confirm its status | Richmond Hill | Canada | Unknown status |
| XLR8 Medical Research Coordinator of this site? Confirm its status | Windsor | Canada | Unknown status |
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Hosp. of Chengde Medical University Coordinator of this site? Confirm its status | Chengde | China | Unknown status |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| the First Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sanmenxia Central Hospital Coordinator of this site? Confirm its status | Sanmenxia | China | Unknown status |
| Wuxi People's Hospital Coordinator of this site? Confirm its status | Wuxi | China | Unknown status |
| The Second Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| ISA - Interdisciplinary Study Association GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR Coordinator of this site? Confirm its status | Blankenfelde-Mahlow | Germany | Active, not recruiting |
| Studienzentrum an der Hase GbR Coordinator of this site? Confirm its status | Bramsche | Germany | Active, not recruiting |
| Derma-Study-Center Friedrichshafen GmbH Coordinator of this site? Confirm its status | Friedrichshafen | Germany | Active, not recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Active, not recruiting |
| LMU Klinikum Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Miyata Dermatology Clinic Coordinator of this site? Confirm its status | Matsudo | Japan | Unknown status |
| Kume Clinic Coordinator of this site? Confirm its status | Nishiku | Japan | Unknown status |
| Kindai University Hospital Coordinator of this site? Confirm its status | Sakai | Japan | Unknown status |
| Teikyo University Hospital Coordinator of this site? Confirm its status | tabashi City | Japan | Unknown status |
| Jitaikai Tachikawa dermatology clinic Coordinator of this site? Confirm its status | Tachikawa | Japan | Unknown status |
| Nomura Dermatology Clinic Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Solumed Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Klinika Ambroziak Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Kaohsiung Veterans General Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Taipei Medical University Shuang Ho Hospital Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| Chung Shan Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Linkou Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Red River Research Partners, LLC Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| First OC Dermatology Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| Center for Clinical Studies Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Dawes Fretzin Clinical Research Group Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of California Los Angeles - Division of Dermatology Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Driven Research LLC Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Clinical Research Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Oregon Dermatology and Research Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Arlington Dermatology Coordinator of this site? Confirm its status | Rolling Meadows | United States | Unknown status |
| Progressive Clinical Research Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Southern California Dermatology Coordinator of this site? Confirm its status | Santa Ana | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.