Active — Not RecruitingPhase 2

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

United States75 participantsStarted 2023-09-12

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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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.

What they're measuring

Part A: Mean relative percent change in SALT score

Timeframe: 24 Weeks

Part B: Mean percent change from baseline in SALT score

Timeframe: 36 weeks

Trial details

NCT IDNCT06018428

SponsorQ32 Bio Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

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