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

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join if…

• 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

🚫 You may not be able to join if…

• 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

• First OC Dermatology, Fountain Valley, California, United States
• University of California Los Angeles - Division of Dermatology, Los Angeles, California, United States
• Southern California Dermatology, Santa Ana, California, United States
• Driven Research LLC, Miami, Florida, United States
• Arlington Dermatology, Rolling Meadows, Illinois, United States
• Dawes Fretzin Clinical Research Group, Indianapolis, Indiana, United States
• Henry Ford Health System, Detroit, Michigan, United States
• Red River Research Partners LLC, Fargo, North Dakota, United States
• Oregon Dermatology and Research Center, Portland, Oregon, United States
• Clinical Research Philadelphia, Philadelphia, Pennsylvania, United States
• Center for Clinical Studies, Houston, Texas, United States
• Progressive Clinical Research, San Antonio, Texas, United States

+ 50 more sites.

Who to contact

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

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07230860.