Status:
ACTIVE_NOT_RECRUITING
A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)
Lead Sponsor:
Q32 Bio Inc.
Conditions:
Alopecia Areata
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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. P...
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 pla...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
September 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06018428
Start Date
September 12 2023
End Date
September 1 2026
Last Update
October 31 2025
Active Locations (33)
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1
Scottsdale, Arizona
Scottsdale, Arizona, United States, 85255
2
Fayetteville, Arkansas
Fayetteville, Arkansas, United States, 72703
3
Hot Springs, Arkansas
Hot Springs, Arkansas, United States, 71913
4
Encinitas, California
Encinitas, California, United States, 92024