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

Description

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.

Conditions

Alopecia Areata

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Alopecia Areata
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Scottsdale, Arizona, Scottsdale, Arizona, United States, 85255

Fayetteville

Fayetteville, Arkansas, Fayetteville, Arkansas, United States, 72703

Hot Springs

Hot Springs, Arkansas, Hot Springs, Arkansas, United States, 71913

Encinitas

Encinitas, California, Encinitas, California, United States, 92024

Fountain Valley

Fountain Valley, California, Fountain Valley, California, United States, 92708

Lomita

Lomita, California, Lomita, California, United States, 90717

New Haven

New Haven, Connecticut, New Haven, Connecticut, United States, 06519

Miami

Miami, Florida, Miami, Florida, United States, 33173

Tampa

Tampa, Florida, Tampa, Florida, United States, 33613

Clarksville

Clarksville, Indiana, Clarksville, Indiana, United States, 47129

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Q32 Bio Inc.,

Study Record Dates

2026-09