A Study of JNJ-95475939 in the Treatment of Participants With Moderate to Severe Atopic Dermatitis (AD)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Dermatitis, Atopic

In brief

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.

Key facts

Study ID

NCT06881251

Run by

Janssen Research & Development, LLC

People needed

256

Starts

2025-02-26

Expected to finish

2026-04-07

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…

• 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

You may not qualify if…

• 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 including skin infections, that, according to the investigator, could interfere with efficacy assessments
• Current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
• Recent case of eczema herpeticum, herpes zoster within 8 weeks before screening, or history of recurrent eczema herpeticum
• History of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, untreated latent tuberculosis), recurrent urinary tract infection, fungal infection, mycobacterial infection, or open, draining, or infected skin wounds, or ulcers.
• Diagnosed active parasitic infection or at high risk of parasitic infection, unless treated with antihelminth therapy prior to randomization
• Had major surgery (eg, requiring general anesthesia and hospitalization), within 8 weeks before screening, or will not have fully recovered from surgery, or has such surgery planned during the time the participant is expected to participate in the study

Where it is running

• University of California Los Angeles - Division of Dermatology — Los Angeles, California, United States
• Hamilton Research LLC — Alpharetta, Georgia, United States
• DeNova Research — Chicago, Illinois, United States
• Dawes Fretzin Clinical Research Group LLC — Indianapolis, Indiana, United States
• Indiana Clinical Trial Center — Plainfield, Indiana, United States
• Red River Research Partners LLC — Fargo, North Dakota, United States
• Optima Research — Boardman, Ohio, United States
• Oregon Medical Research Center — Portland, Oregon, United States
• Arlington Center for Dermatology — Arlington, Texas, United States
• Center for Clinical Studies — Houston, Texas, United States
• Progressive Clinical Research — San Antonio, Texas, United States
• Frontier Derm Partners CRO, LLC — Mill Creek, Washington, United States
• CIPREC — Buenos Aires, Argentina
• INAER - Investigacion en Alergias y Enfermedades Respiratorias — Buenos Aires, Argentina
• Instituto de Neumonologia y Dermatologia — Buenos Aires, Argentina
• Derma Internacional S A — Buenos Aires, Argentina
• Ceti - Centro de Estudos Em Terapias Inovadoras — Curitiba, Brazil
• Hospital De Clinicas De Porto Alegre — Porto Alegre, Brazil
• Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP — Ribeirão Preto, Brazil
• Instituto Brasil de Pesquisa Clinica — Rio de Janeiro, Brazil
• Fundacao do ABC Centro Universitario FMABC — Santo André, Brazil
• BR TRIALS Ensaios Clinicos e Consultoria Ltda — São Paulo, Brazil
• Dermatology Research Institute Inc — Calgary, Alberta, Canada
• Dr. Chih ho Hong Medical — Surrey, British Columbia, Canada
• First OC Dermatology — Fountain Valley, California, United States

Full record on ClinicalTrials.gov

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