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

Purpose

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).

Condition

  • Dermatitis, Atopic

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1: JNJ-95597528 (Dose 1) 		Participants will receive JNJ-95597528 Dose 1 on Weeks 0, 2, 12, and 24.
  • Drug: JNJ-95597528
    JNJ-95597528 will be administered subcutaneously.
Experimental
Group 2: JNJ-95597528 (Dose 2 and 3) 		Participants will receive JNJ-95597528 Dose 2 on Week 0 followed by JNJ-95597528 Dose 3 on Weeks 12, and 24.
  • Drug: JNJ-95597528
    JNJ-95597528 will be administered subcutaneously.
Experimental
Group 3: JNJ-95597528 (Dose 4 and 5) 		Participants will receive JNJ-95597528 Dose 4 on Week 0 followed by JNJ-95597528 Dose 5 on Weeks 12, and 24.
  • Drug: JNJ-95597528
    JNJ-95597528 will be administered subcutaneously.
Placebo Comparator
Group 4: Placebo and JNJ-95597528 (Dose 2 and 3) 		Participants will receive placebo from Weeks 0 to 12 , then switch to receive JNJ-95597528 Dose 2 administered at Week 12 followed by Dose 3 at Week 24.
  • Drug: JNJ-95597528
    JNJ-95597528 will be administered subcutaneously.
  • Drug: Placebo
    Placebo will be administered subcutaneously.

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com