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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
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

Full criteria on ClinicalTrials.gov

Sites (67)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CIPREC
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Buenos AiresArgentinaUnknown status
Instituto Medico De Alta Complejidad (IMAC)
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Buenos AiresArgentinaUnknown status
Derma Internacional S A
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Buenos AiresArgentinaUnknown status
DOM Reumatologia
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Buenos AiresArgentinaUnknown status
INAER - Investigacion en Alergias y Enfermedades Respiratorias
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Buenos AiresArgentinaUnknown status
Mautalen- Salud e Investigacion
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CABAArgentinaUnknown status
Instituto de Investigaciones Clínicas Córdoba
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CórdobaArgentinaUnknown status
Centro de Investigaciones Clinicas CIC IESR
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RosarioArgentinaUnknown status
Centro Respiratorio Infantil
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RosarioArgentinaUnknown status
Centro de Investigaciones Medicas Tucuman
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San Miguel de TucumánArgentinaUnknown status
Ceti - Centro de Estudos Em Terapias Inovadoras
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CuritibaBrazilUnknown status
Hospital de Clinicas de Porto Alegre
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Porto AlegreBrazilUnknown status
Instituto Brasil de Pesquisa Clinica
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Rio de JaneiroBrazilUnknown status
Pesquisare Saude
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Santo AndréBrazilUnknown status
Cepes - Fmabc
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São PauloBrazilUnknown status
PSEG trials Centro de Pesquisa Clinica S A
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São PauloBrazilUnknown status
CCA Medical Research Corporation
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AjaxCanadaUnknown status
Simcoderm Medical and Surgical Dermatology Centre
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BarrieCanadaUnknown status
Dermatology Research Institute Inc
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CalgaryCanadaUnknown status
Dr Wei Jing Loo Medicine Professional Corporation
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LondonCanadaUnknown status
DermEdge Research
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MississaugaCanadaUnknown status
Allergy Research Canada Inc.
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Niagara FallsCanadaUnknown status
York Dermatology Clinic and Research Centre
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Richmond HillCanadaUnknown status
XLR8 Medical Research
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WindsorCanadaUnknown status
China-Japan Friendship Hospital
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BeijingChinaUnknown status
Xiangya Hospital Central South University
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ChangshaChinaUnknown status
Hosp. of Chengde Medical University
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ChengdeChinaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
the First Affiliated Hospital of Sun Yat-sen University
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GuangzhouChinaUnknown status
Sanmenxia Central Hospital
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SanmenxiaChinaUnknown status
Wuxi People's Hospital
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WuxiChinaUnknown status
The Second Affiliated Hospital of Xi'an Jiaotong University
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Xi'anChinaUnknown status
ISA - Interdisciplinary Study Association GmbH
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BerlinGermanyActive, not recruiting
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
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Blankenfelde-MahlowGermanyActive, not recruiting
Studienzentrum an der Hase GbR
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BramscheGermanyActive, not recruiting
Derma-Study-Center Friedrichshafen GmbH
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FriedrichshafenGermanyActive, not recruiting
Universitaet Muenster
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MuensterGermanyActive, not recruiting
LMU Klinikum Muenchen AöR
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MunichGermanyActive, not recruiting
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
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MunichGermanyActive, not recruiting
Miyata Dermatology Clinic
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MatsudoJapanUnknown status
Kume Clinic
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NishikuJapanUnknown status
Kindai University Hospital
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SakaiJapanUnknown status
Teikyo University Hospital
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tabashi CityJapanUnknown status
Jitaikai Tachikawa dermatology clinic
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TachikawaJapanUnknown status
Nomura Dermatology Clinic
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YokohamaJapanUnknown status
Centrum Badan Klinicznych PI-House sp. z o.o.
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GdanskPolandCompleted
Solumed Centrum Medyczne Sp. z o.o.
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PoznanPolandCompleted
Klinika Ambroziak Sp. z o.o.
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WarsawPolandCompleted
Kaohsiung Veterans General Hospital
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Kaohsiung CityTaiwanUnknown status
Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Taipei Medical University Shuang Ho Hospital
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New Taipei CityTaiwanUnknown status
Chung Shan Medical University Hospital
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TaichungTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Tri-Service General Hospital
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TaipeiTaiwanUnknown status
Linkou Chang Gung Memorial Hospital
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TaoyuanTaiwanUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
Red River Research Partners, LLC
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FargoUnited StatesUnknown status
First OC Dermatology
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Fountain ValleyUnited StatesUnknown status
Center for Clinical Studies
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HoustonUnited StatesUnknown status
Dawes Fretzin Clinical Research Group
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IndianapolisUnited StatesUnknown status
University of California Los Angeles - Division of Dermatology
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Los AngelesUnited StatesUnknown status
Driven Research LLC
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MiamiUnited StatesUnknown status
Clinical Research Philadelphia
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PhiladelphiaUnited StatesUnknown status
Oregon Dermatology and Research Center
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PortlandUnited StatesUnknown status
Arlington Dermatology
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Rolling MeadowsUnited StatesUnknown status
Progressive Clinical Research
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San AntonioUnited StatesUnknown status
Southern California Dermatology
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Santa AnaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.