A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

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).

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • JNJ-95597528
  • Placebo

Treatment groups

180 Participants
are divided into 4 treatment groups