RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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)

Quick Facts

Study Start:2023-09-12
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06018428

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult men and women, aged 18 to 75 years, inclusive, at the time of informed consent.
  2. 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. 1. History of or diagnosis at screening of any another form of alopecia based on assessment by investigator.
  2. 2. History (lifetime) or presence of hair transplants.
  3. 3. History (lifetime) or presence of micropigmentation of the scalp (Note: Microblading of the eyebrows is permitted).
  4. 4. Use of systemic, topical, or device-based therapy for AA.
  5. 5. History of, recent, or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection or at risk of serious infection.

Contacts and Locations

Study Contact

Q32 Bio Clinical Trials
CONTACT
clinicaltrials@q32bio.com

Study Locations (Sites)

Scottsdale, Arizona
Scottsdale, Arizona, 85255
United States
Fayetteville, Arkansas
Fayetteville, Arkansas, 72703
United States
Hot Springs, Arkansas
Hot Springs, Arkansas, 71913
United States
Encinitas, California
Encinitas, California, 92024
United States
Fountain Valley, California
Fountain Valley, California, 92708
United States
Lomita, California
Lomita, California, 90717
United States
New Haven, Connecticut
New Haven, Connecticut, 06519
United States
Miami, Florida
Miami, Florida, 33173
United States
Tampa, Florida
Tampa, Florida, 33613
United States
Clarksville, Indiana
Clarksville, Indiana, 47129
United States
Burlington, Massachusetts
Burlington, Massachusetts, 01805
United States
Troy, Michigan
Troy, Michigan, 48084
United States
Warren, Michigan
Warren, Michigan, 48192
United States
New York, New York
New York, New York, 11211
United States
Wilmington, North Carolina
Wilmington, North Carolina, 28405
United States
Bexley, Ohio
Bexley, Ohio, 43209
United States
Mason, Ohio
Mason, Ohio, 45040
United States
Mayfield Heights, Ohio
Mayfield Heights, Ohio, 44124
United States
Portland, Oregon
Portland, Oregon, 97225
United States
Austin, Texas
Austin, Texas, 78759
United States
Frisco, Texas
Frisco, Texas, 75034
United States
Houston, Texas
Houston, Texas, 77056
United States
San Antonio, Texas
San Antonio, Texas, 78213
United States
Jordan, Utah
Jordan, Utah, 84095
United States
Spokane, Washington
Spokane, Washington, 99202
United States

Collaborators and Investigators

Sponsor: Q32 Bio Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-12
Study Completion Date2026-09

Study Record Updates

Study Start Date2023-09-12
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • Areata, Alopecia
  • Alopecia
  • Dermatitis
  • Hair Loss
  • Trichoscopy
  • Atopic

Additional Relevant MeSH Terms

  • Alopecia Areata