A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Dermatitis, Atopic
In brief
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).
Key facts
- Study ID
- NCT07230860
- Run by
- Janssen Research & Development, LLC
- People needed
- 189
- Starts
- 2026-01-20
- Expected to finish
- 2028-02-10
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of California Los Angeles - Division of Dermatology — Los Angeles, California, United States
- Southern California Dermatology — Santa Ana, California, United States
- Driven Research LLC — Miami, Florida, United States
- Arlington Dermatology — Rolling Meadows, Illinois, United States
- Dawes Fretzin Clinical Research Group — Indianapolis, Indiana, United States
- Henry Ford Health System — Detroit, Michigan, United States
- Red River Research Partners LLC — Fargo, North Dakota, United States
- Oregon Dermatology and Research Center — Portland, Oregon, United States
- Clinical Research Philadelphia — Philadelphia, Pennsylvania, United States
- Center for Clinical Studies — Houston, Texas, United States
- Progressive Clinical Research — San Antonio, Texas, United States
- 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
- First OC Dermatology — Fountain Valley, California, United States
Full record on ClinicalTrials.gov
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