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Testing a new treatment for severe hair loss due to alopecia areata

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

Phase 2 Interventional Q32 Bio Inc. · NCT06018428

This study is testing a new treatment for severe hair loss caused by alopecia areata to see if it can help adults regrow their hair.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment75 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorQ32 Bio Inc. Industry-sponsored
Locations25 sites (Scottsdale, Arizona and 24 other locations)
Trial IDNCT06018428 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy, safety, and tolerability of bempikibart (ADX-914) in adults with severe alopecia areata. The study consists of a randomized, double-blind, placebo-controlled phase followed by an open-label extension phase. Participants receive subcutaneous injections of the treatment or placebo every two weeks for 24 weeks, with follow-up assessments for an additional 12 weeks. The open-label extension allows participants who showed hair regrowth to continue receiving the treatment for an additional six months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a clinical diagnosis of severe to very severe alopecia areata, characterized by at least 50% total scalp hair loss.

Not a fit: Patients with other forms of alopecia, a history of hair transplants, or those currently using other therapies for alopecia areata may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve hair regrowth and quality of life for patients suffering from severe alopecia areata.

How similar studies have performed: Other studies have shown promise in treating alopecia areata with similar approaches, but this specific treatment is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 Exclusion Criteria:

1. History of or diagnosis at screening of any another form of alopecia based on assessment by investigator.
2. History (lifetime) or presence of hair transplants.
3. History (lifetime) or presence of micropigmentation of the scalp (Note: Microblading of the eyebrows is permitted).
4. Use of systemic, topical, or device-based therapy for AA.
5. History of, recent, or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection or at risk of serious infection.

Where this trial is running

Scottsdale, Arizona and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alopecia AreataAreata, AlopeciaAlopeciaDermatitisHair LossTrichoscopyAtopic
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.