Dermatitis, Atopic
Conditions
Interventions
[Arms]
Experimental: Group 1: JNJ-95597528 (Dose 1)
Participants will receive JNJ-95597528 Dose 1 on Weeks 0, 2, 12, and 24.
[Assigned Interventions]
Drug: JNJ-95597528
JNJ-95597528 will be administer
Sponsors
Ohashi Hiroki
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of Participants with Eczema Area and Severity Index (EASI) 75 Response at Week 12 EASI-75 response is defined as at least 75 percent (%) improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD. [Time Frame: Week 12] | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Proportion of Participants with EASI 90 Response at Week 12 EASI-90 response is defined as at least 90% improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD. [Time Frame: Week 12] 3. Proportion of Participants with EASI 100 Response at Week 12 EASI-100 response is defined as at least 100% improvement from baseline in EASI total score. EASI is a validated measure used to assess the severity and extent of AD with scores ranging from 0 to 72. Four AD disease characteristics (erythema, thickness [induration, papulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6. In each body region, the area is expressed as 0, 1 (1% to 9%), 2 (10% to 29%), 3 (30% to 49%), 4 (50% to 69%), 5 (70% to 89%), or 6 (90% to 100%). Here higher score indicates higher severity of AD. [Time Frame: Week 12] 4. Percent Change from Baseline in EASI Total Score at Week 12 Percent change from baseline in EASI total score will be reported. EASI is a validated measure used to assess the severity and extent of | — |
Countries
Argentina, Brazil, Canada, China, Germany, Japan, Poland, Taiwan Province Of China, United States Of America
Contacts
Public ContactMedical Information Center
Janssen Pharmaceutical K.K.
Outcome results
None listed