Home › Trials › NCT06881251

Evaluating JNJ-95475939 for treating moderate to severe atopic dermatitis

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of JNJ-95475939 for the Treatment of Participants With Moderate to Severe AD

Phase 2 Interventional Janssen Research & Development, LLC · NCT06881251

This study is testing a new medication called JNJ-95475939 to see if it can help people with moderate to severe atopic dermatitis feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsdupilumab, lebrikizumab, tralokinumab
Locations49 sites (Fountain Valley, California and 48 other locations)
Trial IDNCT06881251 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of JNJ-95475939 compared to a placebo in individuals suffering from moderate to severe atopic dermatitis. Participants must have a documented history of chronic atopic dermatitis and meet specific severity criteria, including a minimum EASI score and body surface area involvement. The study will involve administering the investigational drug alongside a placebo to determine its impact on symptoms and overall skin condition.

Who should consider this trial

Good fit: Ideal candidates are individuals with chronic atopic dermatitis who have not responded adequately to previous topical or systemic treatments.

Not a fit: Patients with mild atopic dermatitis or those who have not experienced inadequate responses to prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with moderate to severe atopic dermatitis by providing a new therapeutic option.

How similar studies have performed: Other studies have shown promise with similar approaches in treating atopic dermatitis, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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 this trial is running

Fountain Valley, California and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Dermatitis, Atopic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.