A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatiti⦠(NCT06881251) | Clinical Trial Compass
Active ā Not RecruitingPhase 2
A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD)
United States256 participantsStarted 2025-02-26
Plain-language summary
The purpose of this study is to evaluate how well JNJ-95475939 works as compared to placebo in participants with moderate to severe atopic dermatitis.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria:
* Chronic Atopic Dermatitis (AD), according to American Academy of Dermatology Consensus Criteria with onset of symptoms at least 1 year prior to the screening visit
* Eczema Area and Severity Index (EASI) score greater than and equal to (\>=) 16 at the screening and baseline visits
* Validated investigator global assessment for AD (vIGA-AD) score \>= 3 at the screening and baseline visits
* \>= 10% body surface area (BSA) of AD involvement at the screening and baseline visits
* Baseline Peak Pruritus Numeric(al) Rating Scale (PP-NRS) average score of \>=4
* Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, or inadequate response to systemic therapies (within 12 months before screening)
* Participant has applied a moisturizer at least once daily for at least 7 days before the baseline visit
Exclusion criteria:
* Experienced primary efficacy failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents (eg, severe ocular surface disease, dupilumab-associated facial redness) inhibiting IL-4Rα, IL-4, and/or IL-13 signaling (eg, dupilumab, lebrikizumab, or tralokinumab)
* Participant is pregnant or breastfeeding, or planning to become pregnant or breastfeed during the study
* Active skin disease other than AD including eczema herpeticum, molluscum contagiosum, impetigo, psoriasis or has any other ongoing significant skin condition includinā¦
What they're measuring
1
Percentage of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12