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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06018428 | A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA) | PHASE2 | ACTIVE NOT_RECRUITING | 75 | — | — | Sep 12, 2023 | Sep 1, 2026 | May 8, 2026 | 33 | United States, Canada |
Part A: Mean relative percent change in SALT score at 24 weeks compared with baseline
Part B: Mean percent change from baseline in SALT score at Week 36
| Arm | Type | Description |
|---|---|---|
| Experimental: bempikibart (ADX-914) | EXPERIMENTAL | 200mg dose of bempikibart (ADX-914) administered via injection under the skin |
| Name | Type | Description |
|---|---|---|
| bempikibart (ADX-914) | DRUG | Subcutaneous administration of bempikibart (ADX-914) |
Key Inclusion Criteria: 1. Adult men and women, aged 18 to 75 years, inclusive, at the time of informed consent. 2. Clinical diagnosis of severe to very severe alopecia areata, defined as the presence of ≥50% total scalp hair loss at screening and baseline as measured by the SALT score. Key Exclus...