A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)
NCT06018428 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2026-05-08
Summary
Part A is a randomized, double-blind, placebo-controlled, multi-center Proof-of-Concept (POC) Trial in subjects with severe Alopecia Areata. All participants in Part A have completed participation.
Part B is a multicenter, open-label study to assess the efficacy, safety, and tolerability of bempikibart (ADX-914) in participants with severe Alopecia Areata.
Conditions
Interventions
- DRUG
-
bempikibart (ADX-914)
Subcutaneous administration of bempikibart (ADX-914)
Sponsors & Collaborators
-
Q32 Bio Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-12
- Primary Completion
- 2026-06-30
- Completion
- 2026-09-30
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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