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)
Overview
- Phase
- Phase 2
- Intervention
- bempikibart (ADX-914)
- Conditions
- Alopecia Areata
- Sponsor
- Q32 Bio Inc.
- Enrollment
- 75
- Locations
- 27
- Primary Endpoint
- Part A: Mean relative percent change in SALT score
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult men and women, aged 18 to 75 years, inclusive, at the time of informed consent.
- •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.
Exclusion Criteria
- •History of or diagnosis at screening of any another form of alopecia based on assessment by investigator.
- •History (lifetime) or presence of hair transplants.
- •History (lifetime) or presence of micropigmentation of the scalp (Note: Microblading of the eyebrows is permitted).
- •Use of systemic, topical, or device-based therapy for AA.
- •History of, recent, or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection or at risk of serious infection.
Arms & Interventions
Experimental: bempikibart (ADX-914)
200mg dose of bempikibart (ADX-914) administered via injection under the skin
Intervention: bempikibart (ADX-914)
Outcomes
Primary Outcomes
Part A: Mean relative percent change in SALT score
Time Frame: 24 Weeks
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
Time Frame: 36 weeks
Part B: Mean percent change from baseline in SALT score at Week 36
Secondary Outcomes
- Part A: Mean relative percentage change SALT score compared with baseline at Weeks 6,12, and 18.(18 Weeks)
- Part A: Mean relative percentage change in SALT score at 24 weeks compared with treatment nadir.(24 Weeks)
- Part A: Absolute change in SALT score compared with baseline at Weeks 6, 12, 18, and 24.(24 Weeks)
- Part A: Proportion of participants who achieve ≥30% and ≥50% relative reduction in SALT score compared with baseline at Weeks 12, 18, and 24.(24 Weeks)
- Part A: Proportion of participants with absolute SALT score ≤5, ≤10, ≤20, and ≤30 at Weeks 12, 18, and 24.(24 Weeks)
- Part A: Overall Safety as evaluated by number of adverse events (AEs).(36 Weeks)
- Part B: Proportion of participants who achieve ≥50% relative reduction in SALT score compared with baseline at 36 weeks(36 Weeks)
- Part B: Mean percent change from baseline in SALT score at Week 52(52 Weeks)
- Part B: Proportion of participants with absolute SALT score ≤20 and ≤30 at Week 36.(36 Weeks)