A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)
NCT ID: NCT06018428
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
75 participants
INTERVENTIONAL
2023-09-12
2026-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental: bempikibart (ADX-914)
200mg dose of bempikibart (ADX-914) administered via injection under the skin
bempikibart (ADX-914)
Subcutaneous administration of bempikibart (ADX-914)
Interventions
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bempikibart (ADX-914)
Subcutaneous administration of bempikibart (ADX-914)
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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Q32 Bio Inc.
INDUSTRY
Responsible Party
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Locations
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Scottsdale, Arizona
Scottsdale, Arizona, United States
Fayetteville, Arkansas
Fayetteville, Arkansas, United States
Hot Springs, Arkansas
Hot Springs, Arkansas, United States
Encinitas, California
Encinitas, California, United States
Fountain Valley, California
Fountain Valley, California, United States
Lomita, California
Lomita, California, United States
New Haven, Connecticut
New Haven, Connecticut, United States
Miami, Florida
Miami, Florida, United States
Tampa, Florida
Tampa, Florida, United States
Clarksville, Indiana
Clarksville, Indiana, United States
Bowling Green, Kentucky
Bowling Green, Kentucky, United States
Burlington, Massachusetts
Burlington, Massachusetts, United States
Troy, Michigan
Troy, Michigan, United States
Warren, Michigan
Warren, Michigan, United States
New York, New York
New York, New York, United States
New York, New York
New York, New York, United States
Wilmington, North Carolina
Wilmington, North Carolina, United States
Bexley, Ohio
Bexley, Ohio, United States
Clinical Trials
Canton, Ohio, United States
Mason, Ohio
Mason, Ohio, United States
Mayfield Heights, Ohio
Mayfield Heights, Ohio, United States
Portland, Oregon
Portland, Oregon, United States
Austin, Texas
Austin, Texas, United States
Frisco, Texas
Frisco, Texas, United States
Houston, Texas
Houston, Texas, United States
San Antonio, Texas
San Antonio, Texas, United States
Jordan, Utah
Jordan, Utah, United States
Spokane, Washington
Spokane, Washington, United States
Clinical Trials
Calgary, Alberta, Canada
Clinical Trials
Winnipeg, Manitoba, Canada
Clinical Trials
Oakville, Ontario, Canada
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Peterborough, Ontario, Canada
Clinical Trials
Waterloo, Ontario, Canada
Countries
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Other Identifiers
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SIGNAL-AA
Identifier Type: OTHER
Identifier Source: secondary_id
ADX-914-203
Identifier Type: -
Identifier Source: org_study_id
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