A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis (READY-AD)

Janssen (J&J Innovative Medicine)

Status and phase: Begins enrollment this month; Phase 2

Conditions: Dermatitis, Atopic

Treatments: Drug: JNJ-95597528; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07230860

2025-523464-20-00 (Registry Identifier)

95597528ADM2001 (Other Identifier)

Details and patient eligibility

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).

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 4 patient groups, including a placebo group

Group 1: JNJ-95597528 (Dose 1)

Experimental group

Description:

Participants will receive JNJ-95597528 Dose 1 on Weeks 0, 2, 12, and 24.

Treatment:

Drug: JNJ-95597528

Group 2: JNJ-95597528 (Dose 2 and 3)

Experimental group

Description:

Participants will receive JNJ-95597528 Dose 2 on Week 0 followed by JNJ-95597528 Dose 3 on Weeks 12, and 24.

Treatment:

Drug: JNJ-95597528

Group 3: JNJ-95597528 (Dose 4 and 5)

Experimental group

Description:

Participants will receive JNJ-95597528 Dose 4 on Week 0 followed by JNJ-95597528 Dose 5 on Weeks 12, and 24.

Treatment:

Drug: JNJ-95597528

Group 4: Placebo and JNJ-95597528 (Dose 2 and 3)

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: JNJ-95597528