Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07230860 | A Study of JNJ-95597528 in Participants With Moderate to Severe Atopic Dermatitis | PHASE2 | RECRUITING | 180 | — | — | Jan 20, 2026 | Feb 10, 2028 | Jun 5, 2026 | 62 | United States, Argentina +7 |
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.
| Arm | Type | Description |
|---|---|---|
| Group 1: JNJ-95597528 (Dose 1) | EXPERIMENTAL | Participants will receive JNJ-95597528 Dose 1 on Weeks 0, 2, 12, and 24. |
| Group 2: JNJ-95597528 (Dose 2 and 3) | EXPERIMENTAL | Participants will receive JNJ-95597528 Dose 2 on Week 0 followed by JNJ-95597528 Dose 3 on Weeks 12, and 24. |
| Group 3: JNJ-95597528 (Dose 4 and 5) | EXPERIMENTAL | Participants will receive JNJ-95597528 Dose 4 on Week 0 followed by JNJ-95597528 Dose 5 on Weeks 12, and 24. |
| Group 4: Placebo and JNJ-95597528 (Dose 2 and 3) | PLACEBO_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| JNJ-95597528 | DRUG | JNJ-95597528 will be administered subcutaneously. |
| Placebo | DRUG | Placebo will be administered subcutaneously. |
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 Dermatol...