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.

Recruiting Locations

First OC Dermatology
Fountain Valley, California 92708

Southern California Dermatology
Santa Ana, California 92701

Driven Research LLC
Coral Gables, Florida 33134

Arlington Dermatology
Rolling Meadows, Illinois 60008

Dawes Fretzin Clinical Research Group
Indianapolis, Indiana 46250

Henry Ford Health System
Detroit, Michigan 48202

Red River Research Partners LLC
Fargo, North Dakota 58103

Oregon Dermatology and Research Center
Portland, Oregon 97210

Clinical Research Philadelphia
Philadelphia, Pennsylvania 19114

Center for Clinical Studies
Houston, Texas 77004

Progressive Clinical Research
San Antonio, Texas 78213

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

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