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JNJ-95597528 for moderate to severe atopic dermatitis

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants With Moderate to Severe Atopic Dermatitis

Phase 2 Interventional Janssen Research & Development, LLC · NCT07230860

This study will test whether JNJ-95597528 reduces symptoms in people with moderate to severe atopic dermatitis compared with placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Locations56 sites (Fountain Valley, California and 55 other locations)
Trial IDNCT07230860 on ClinicalTrials.gov

What this trial studies

This Phase 2, placebo-controlled interventional study gives participants either JNJ-95597528 or a matching placebo and compares clinical outcomes between groups. Eligibility requires chronic moderate to severe atopic dermatitis with specific thresholds for EASI, vIGA-AD, and body surface area involvement and a history of inadequate response or inadvisability to prior topical or systemic therapies. Key measures will include standard eczema severity scores (such as EASI and vIGA-AD), percent body surface area affected, and safety monitoring including ECGs and routine clinical assessments. The trial is conducted at a small number of outpatient dermatology sites in the United States.

Who should consider this trial

Good fit: People with chronic atopic dermatitis (onset ≥1 year) who have EASI ≥16, vIGA-AD ≥3, ≥10% BSA involvement, and a documented inadequate response or inadvisability to medicated topical or systemic therapies are ideal candidates.

Not a fit: People with mild atopic dermatitis, those without the required severity or prior treatment history, or individuals with major uncontrolled medical problems or abnormal screening ECGs may not benefit or may be ineligible.

Why it matters

Potential benefit: If successful, JNJ-95597528 could offer a new systemic treatment option that reduces skin inflammation and symptoms for people with moderate to severe atopic dermatitis.

How similar studies have performed: Other systemic therapies for moderate-to-severe atopic dermatitis, including various biologics and JAK inhibitors, have shown meaningful symptom improvement, but the effectiveness of JNJ-95597528 itself remains to be demonstrated.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 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 this trial is running

Fountain Valley, California and 55 other locations

+6 more sites — see ClinicalTrials.gov for the full list.

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.