A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)
- Conditions
- Alopecia Areata
- Interventions
- Drug: bempikibart (ADX-914)
- Registration Number
- NCT06018428
- Lead Sponsor
- Q32 Bio Inc.
- 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.
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.
- 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 placebo is administered subcutaneously in the clinic setting every 2 weeks for 24 weeks, with follow-up for 12 weeks. Subjects will be randomized 3:1 to drug vs placebo. All participants in Part A have completed participation.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental: bempikibart (ADX-914) bempikibart (ADX-914) 200mg dose of bempikibart (ADX-914) administered via injection under the skin
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Part A: Mean relative percentage change SALT score compared with baseline at Weeks 6,12, and 18. 18 Weeks Part A: Mean relative percentage change in SALT score at 24 weeks compared with treatment nadir. 24 Weeks Part A: Absolute change in SALT score compared with baseline at Weeks 6, 12, 18, and 24. 24 Weeks Part A: Proportion of participants who achieve ≥30% and ≥50% relative reduction in SALT score compared with baseline at Weeks 12, 18, and 24. 24 Weeks Part A: Proportion of participants with absolute SALT score ≤5, ≤10, ≤20, and ≤30 at Weeks 12, 18, and 24. 24 Weeks Part A: Overall Safety as evaluated by number of adverse events (AEs). 36 Weeks Part B: Proportion of participants who achieve ≥50% relative reduction in SALT score compared with baseline at 36 weeks 36 Weeks Part B: Mean percent change from baseline in SALT score at Week 52 52 Weeks Part B: Proportion of participants with absolute SALT score ≤20 and ≤30 at Week 36. 36 Weeks
Trial Locations
- Locations (25)
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
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
Wilmington, North Carolina
🇺🇸Wilmington, North Carolina, United States
Bexley, Ohio
🇺🇸Bexley, 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