NCT06018428

A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)

A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Proof-of-Concept Trial With Part B and Open-label Extension of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Q32 Bio Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Part A is a Phase IIa, Randomized, Double-blind, Placebo-controlled, multi-center Proof-of-Concept (POC) study in adult subjects with severe Alopecia Areata (AA). Bempikibart (ADX-914) or matching placebo is administered subcutaneously in the clinic setting every 2 weeks for 24 weeks, with follow-up for 12 weeks. Subjects will be randomized 3:1 to drug vs placebo. All participants in Part A have completed participation. Part B is a multicenter, open-label study comprised of a screening period of up to 4 weeks, a treatment period of 36 weeks, and a follow-up period of 16 weeks, for a total study duration of up to 56 weeks. Open Label Extension Cohort is a multicenter, open-label extension to assess the long-term efficacy, safety, and tolerability of bempikibart (ADX-914) in participants with severe AA who experienced hair regrowth as participants in Part A of the study. Participants enrolled in the Open Label Extension Cohort will receive bempikibart (ADX-914) for a duration of 6 months followed by a 16-week follow-up period.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	bempikibart (ADX-914)	Subcutaneous administration of bempikibart (ADX-914)

Timeline

• Start date: 2023-09-12
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2023-08-30
• Last updated: 2025-10-31

Locations

33 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study