Clinical trial NCT06018428: A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)
Official title: A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Proof-of-Concept Trial With Part B Open-label Extension of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alopecia Areata
Keywords: Areata, Alopecia
Alopecia
Dermatitis
Hair Loss
Trichoscopy
Atopic
Lead sponsor: Q32 Bio Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Part A: Mean relative percent change in SALT score
timeFrame: 24 Weeks
measure: Part B: Mean percent change from baseline in SALT score
timeFrame: 36 weeks
Secondary outcomes:
measure: Part A: Mean relative percentage change SALT score compared with baseline at Weeks 6,12, and 18.
timeFrame: 18 Weeks
measure: Part A: Mean relative percentage change in SALT score at 24 weeks compared with treatment nadir.
timeFrame: 24 Weeks
measure: Part A: Absolute change in SALT score compared with baseline at Weeks 6, 12, 18, and 24.
timeFrame: 24 Weeks
measure: Part A: Proportion of participants who achieve ≥30% and ≥50% relative reduction in SALT score compared with baseline at Weeks 12, 18, and 24.
timeFrame: 24 Weeks
measure: Part A: Proportion of participants with absolute SALT score ≤5, ≤10, ≤20, and ≤30 at Weeks 12, 18, and 24.
timeFrame: 24 Weeks
measure: Part A: Overall Safety as evaluated by number of adverse events (AEs).
timeFrame: 36 Weeks
measure: Part B: Proportion of participants who achieve ≥50% relative reduction in SALT score compared with baseline at 36 weeks
timeFrame: 36 Weeks
measure: Part B: Mean percent change from baseline in SALT score at Week 52
timeFrame: 52 Weeks
measure: Part B: Proportion of participants with absolute SALT score ≤20 and ≤30 at Week 36.
timeFrame: 36 Weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale, Arizona
state: Arizona
city: Fayetteville
country: United States
facility: Fayetteville, Arkansas
state: Arkansas
city: Hot Springs
country: United States
facility: Hot Springs, Arkansas
state: Arkansas
city: Encinitas
country: United States
facility: Encinitas, California
state: California
city: Fountain Valley
country: United States
facility: Fountain Valley, California
state: California
city: Lomita
country: United States
facility: Lomita, California
state: California
city: New Haven
country: United States
facility: New Haven, Connecticut
state: Connecticut
city: Miami
country: United States
facility: Miami, Florida
state: Florida
city: Tampa
country: United States
facility: Tampa, Florida
state: Florida
city: Clarksville
country: United States
facility: Clarksville, Indiana
state: Indiana
city: Burlington
country: United States
facility: Burlington, Massachusetts
state: Massachusetts
city: Troy
country: United States
facility: Troy, Michigan
state: Michigan
city: Warren
country: United States
facility: Warren, Michigan
state: Michigan
city: New York
country: United States
facility: New York, New York
state: New York
city: Wilmington
country: United States
facility: Wilmington, North Carolina
state: North Carolina
city: Bexley
country: United States
facility: Bexley, Ohio
state: Ohio
city: Mason
country: United States
facility: Mason, Ohio
state: Ohio
city: Mayfield Heights
country: United States
facility: Mayfield Heights, Ohio
state: Ohio
city: Portland
country: United States
facility: Portland, Oregon
state: Oregon
city: Austin
country: United States
facility: Austin, Texas
state: Texas
city: Frisco
country: United States
facility: Frisco, Texas
state: Texas
city: Houston
country: United States
facility: Houston, Texas
state: Texas
city: San Antonio
country: United States
facility: San Antonio, Texas
state: Texas
city: Jordan
country: United States
facility: Jordan, Utah
state: Utah
city: Spokane
country: United States
facility: Spokane, Washington
state: Washington
Study officials:
References: