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Alopecia AreataPhase 2SIGNAL-AANCT06018428

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

A Phase 2 study testing bempikibart (ADX-914) in people with Alopecia Areata, run by Q32 Bio Inc. at 33 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Alopecia Areata
What is being tested?
bempikibart (ADX-914)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
33 sitesin 2 countries
Study dates
12 Sep 2023to Sep 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

33 sites in 2 countries.

33 sites in 2 countries

United States28 sites

  • Austin, Texas

    Austin, Texas, 78759

  • Bexley, Ohio

    Bexley, Ohio, 43209

  • Bowling Green, Kentucky

    Bowling Green, Kentucky, 42104

  • Burlington, Massachusetts

    Burlington, Massachusetts, 01805

  • Clinical Trials

    Canton, Ohio, 44718

  • Clarksville, Indiana

    Clarksville, Indiana, 47129

  • Encinitas, California

    Encinitas, California, 92024

  • Fayetteville, Arkansas

    Fayetteville, Arkansas, 72703

  • Fountain Valley, California

    Fountain Valley, California, 92708

  • Frisco, Texas

    Frisco, Texas, 75034

  • Hot Springs, Arkansas

    Hot Springs, Arkansas, 71913

  • Houston, Texas

    Houston, Texas, 77056

  • Jordan, Utah

    Jordan, Utah, 84095

  • Lomita, California

    Lomita, California, 90717

  • Mason, Ohio

    Mason, Ohio, 45040

  • Mayfield Heights, Ohio

    Mayfield Heights, Ohio, 44124

  • Miami, Florida

    Miami, Florida, 33173

  • New Haven, Connecticut

    New Haven, Connecticut, 06519

  • New York, New York

    New York, New York, 10012

  • New York, New York

    New York, New York, 10023

  • Portland, Oregon

    Portland, Oregon, 97225

  • San Antonio, Texas

    San Antonio, Texas, 78213

  • Scottsdale, Arizona

    Scottsdale, Arizona, 85255

  • Spokane, Washington

    Spokane, Washington, 99202

  • Tampa, Florida

    Tampa, Florida, 33613

  • Troy, Michigan

    Troy, Michigan, 48084

  • Warren, Michigan

    Warren, Michigan, 48192

  • Wilmington, North Carolina

    Wilmington, North Carolina, 28405

Other trials in United States

Canada5 sites

  • Clinical Trials

    Calgary, Alberta, T1Y 0B4

  • Clinical Trials

    Oakville, Ontario, L6J 7W5

  • Clinical Trials

    Peterborough, Ontario, K9J 5K2

  • Clinical Trials

    Waterloo, Ontario, N2J 1C4

  • Clinical Trials

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

About this study

Official title: 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)

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.

Read the 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.

Part A 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.

Part B 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 B of the study. Participants enrolled in the Open Label Extension Cohort will receive bempikibart (ADX-914) for a treatment period of 36 weeks, and follow-up period of 16 weeks, for a total study duration of up to 52 weeks.

Conditions
Alopecia Areata
Being tested
bempikibart (ADX-914)
Keywords
Areata, Alopecia, Alopecia, Dermatitis, Hair Loss, Trichoscopy, Atopic
Medical subject headings
Alopecia Areata, Alopecia, Dermatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bempikibart (ADX-914)Drug

    Subcutaneous administration of bempikibart (ADX-914)

Study groups in NCT06018428
Study groupRoleWhat they receive
Experimental: bempikibart (ADX-914)Experimental200mg dose of bempikibart (ADX-914) administered via injection under the skin
Receives: Drug: bempikibart (ADX-914)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Mean relative percent change in SALT score

    Part A: Mean relative percent change in SALT score at 24 weeks compared with baseline

    Measured: 24 Weeks

  2. Part B: Mean percent change from baseline in SALT score

    Part B: Mean percent change from baseline in SALT score at Week 36

    Measured: 36 weeks

Secondary outcomes (9)

  1. Part A: Mean relative percentage change SALT score compared with baseline at Weeks 6,12, and 18.

    Measured: 18 Weeks

  2. Part A: Mean relative percentage change in SALT score at 24 weeks compared with treatment nadir.

    Measured: 24 Weeks

  3. Part A: Absolute change in SALT score compared with baseline at Weeks 6, 12, 18, and 24.

    Measured: 24 Weeks

  4. Part A: Proportion of participants who achieve ≥30% and ≥50% relative reduction in SALT score compared with baseline at Weeks 12, 18, and 24.

    Measured: 24 Weeks

  5. Part A: Proportion of participants with absolute SALT score ≤5, ≤10, ≤20, and ≤30 at Weeks 12, 18, and 24.

    Measured: 24 Weeks

  6. Part A: Overall Safety as evaluated by number of adverse events (AEs).

    Measured: 36 Weeks

  7. Part B: Proportion of participants who achieve ≥50% relative reduction in SALT score compared with baseline at 36 weeks

    Measured: 36 Weeks

  8. Part B: Mean percent change from baseline in SALT score at Week 52

    Measured: 52 Weeks

  9. Part B: Proportion of participants with absolute SALT score ≤20 and ≤30 at Week 36.

    Measured: 36 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2023
  2. Study start12 Sep 2023
  3. Primary completionJun 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06018428
Sponsor's protocol ID
ADX-914-203
Other IDs
SIGNAL-AA
Acronym
SIGNAL-AA
Status last verified
May 2026
First submitted
15 Aug 2023
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bempikibart (ADX-914) in people with Alopecia Areata, run by Q32 Bio Inc. at 33 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Mean relative percent change in SALT score (time frame: 24 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06018428.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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