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

Launched by Q32 BIO INC. · Aug 23, 2023

Keywords

ClinConnect Summary

The SIGNAL-AA trial is studying a new treatment called bempikibart (ADX-914) for people with severe alopecia areata, a condition that causes significant hair loss. This trial is split into two parts. In Part A, participants were randomly assigned to receive either the treatment or a placebo (which looks like the treatment but has no active ingredients) to see how effective it is. Part B will continue to evaluate bempikibart to determine how well it works, how safe it is, and how well patients tolerate it.

To join the trial, participants need to be adults aged 18 to 75 who have been diagnosed with severe alopecia areata, meaning they have lost at least 50% of their hair on their scalp. However, people with other forms of hair loss, those who have had hair transplants, or those currently taking other hair loss treatments are not eligible. Participants in the trial can expect to be closely monitored and may experience some side effects, but the goal is to find a safe and effective treatment for this challenging condition.

Gender

ALL

Eligibility 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.