A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis (NCT07230860) | Clinical Trial Compass
RecruitingPhase 2
A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis
United States180 participantsStarted 2026-01-20
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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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 …
What they're measuring
1
Proportion of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12