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NCT06018428Active, not recruitingPhase 2

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

A Phase 2a, Randomized, Double-blind, Placebo-Controlled, Proof-of-Concept Trial With Part B and Open-label Extension of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)

Source: ClinicalTrials.gov · Last updated 8 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
75 (estimated)
First submitted
15 Aug 2023
Start date
12 Sept 2023
Primary completion date
Jun 2026
Lead sponsor
Q32 Bio Inc.
NCT number
NCT06018428

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 75
  • From 12 Sept 2023 to the primary completion date, Jun 2026
  • 32 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of systemic, topical, or device-based therapy for AA.

Other illness

  • History of or diagnosis at screening of any another form of alopecia based on assessment by investigator.
  • History of, recent, or current clinically serious viral, bacterial, fungal, or parasitic infection or mycobacterial infection or at risk of serious infection.

Other

  • History (lifetime) or presence of hair transplants.
  • History (lifetime) or presence of micropigmentation of the scalp (Note: Microblading of the eyebrows is permitted).

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinical Trials
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CalgaryCanadaUnknown status
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OakvilleCanadaUnknown status
Clinical Trials
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PeterboroughCanadaUnknown status
Clinical Trials
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WaterlooCanadaUnknown status
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WinnipegCanadaUnknown status
Austin, Texas
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AustinUnited StatesUnknown status
Bexley, Ohio
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BexleyUnited StatesUnknown status
Bowling Green, Kentucky
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Bowling GreenUnited StatesUnknown status
Burlington, Massachusetts
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BurlingtonUnited StatesUnknown status
Clinical Trials
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CantonUnited StatesUnknown status
Clarksville, Indiana
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ClarksvilleUnited StatesUnknown status
Encinitas, California
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EncinitasUnited StatesUnknown status
Fayetteville, Arkansas
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FayettevilleUnited StatesUnknown status
Fountain Valley, California
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Fountain ValleyUnited StatesUnknown status
Frisco, Texas
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FriscoUnited StatesUnknown status
Hot Springs, Arkansas
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Hot SpringsUnited StatesUnknown status
Houston, Texas
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HoustonUnited StatesUnknown status
Jordan, Utah
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JordanUnited StatesUnknown status
Lomita, California
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LomitaUnited StatesUnknown status
Mason, Ohio
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MasonUnited StatesUnknown status
Mayfield Heights, Ohio
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Mayfield HeightsUnited StatesUnknown status
Miami, Florida
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MiamiUnited StatesUnknown status
New Haven, Connecticut
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New HavenUnited StatesUnknown status
New York, New York
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New YorkUnited StatesUnknown status
Portland, Oregon
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PortlandUnited StatesUnknown status
San Antonio, Texas
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San AntonioUnited StatesUnknown status
Scottsdale, Arizona
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ScottsdaleUnited StatesUnknown status
Spokane, Washington
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SpokaneUnited StatesUnknown status
Tampa, Florida
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TampaUnited StatesUnknown status
Troy, Michigan
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TroyUnited StatesUnknown status
Warren, Michigan
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WarrenUnited StatesUnknown status
Wilmington, North Carolina
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WilmingtonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.