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Clinical Trials in the USA / NCT06018428
Active, not recruiting Phase 2

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

NCT06018428 · tracked via the Priya Life Science USA tracker
Sponsor
Q32 Bio Inc
Phase
Phase 2
Started
2023-09-12
Last updated
2026-05-08

Condition(s) studied

Alopecia Areata

Investigational drug(s) / intervention(s)

bempikibart (ADX-914) →

bempikibart (ADX-914): Subcutaneous administration of bempikibart (ADX-914)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Part A: Mean relative percent change in SALT score — 24 Weeks
    Part A: Mean relative percent change in SALT score at 24 weeks compared with baseline
  • Part B: Mean percent change from baseline in SALT score — 36 weeks
    Part B: Mean percent change from baseline in SALT score at Week 36

Trial sites (33)

FacilityCityRegionStatus
Scottsdale, Arizona Scottsdale Arizona
Fayetteville, Arkansas Fayetteville Arkansas
Hot Springs, Arkansas Hot Springs Arkansas
Encinitas, California Encinitas California
Fountain Valley, California Fountain Valley California
Lomita, California Lomita California
New Haven, Connecticut New Haven Connecticut
Miami, Florida Miami Florida
Tampa, Florida Tampa Florida
Clarksville, Indiana Clarksville Indiana
Bowling Green, Kentucky Bowling Green Kentucky
Burlington, Massachusetts Burlington Massachusetts
Troy, Michigan Troy Michigan
Warren, Michigan Warren Michigan
New York, New York New York New York
New York, New York New York New York
Wilmington, North Carolina Wilmington North Carolina
Bexley, Ohio Bexley Ohio
Clinical Trials Canton Ohio
Mason, Ohio Mason Ohio
Mayfield Heights, Ohio Mayfield Heights Ohio
Portland, Oregon Portland Oregon
Austin, Texas Austin Texas
Frisco, Texas Frisco Texas
Houston, Texas Houston Texas
San Antonio, Texas San Antonio Texas
Jordan, Utah Jordan Utah
Spokane, Washington Spokane Washington
Clinical Trials Calgary Alberta
Clinical Trials Winnipeg Manitoba
Clinical Trials Oakville Ontario
Clinical Trials Peterborough Ontario
Clinical Trials Waterloo Ontario

More Q32 Bio Inc. trials in the USA

Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD) Active, not recruiting

Other trials for the same condition

Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata Active, not recruiting
A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata Recruiting
A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) Recruiting
Clinical Application of Stem Cell Educator Therapy in Alopecia Areata Active, not recruiting
A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06018428 on ClinicalTrials.gov ↗ ← All trials in the USA