ADX-914 for Severe Alopecia Areata

(SIGNAL-AA Trial)

Not currently recruiting at 36 trial locations

Overseen By Q32 Bio Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Q32 Bio Inc.

Must not be taking: Systemic, topical AA therapies

Disqualifiers: Other alopecia, Hair transplants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ADX-914, an experimental therapy, to determine its effectiveness for individuals with severe alopecia areata, a condition causing significant hair loss on the scalp. The trial aims to assess the treatment's safety and efficacy. Participants will receive the treatment via subcutaneous injection. Suitable candidates have lost at least half of their scalp hair due to alopecia areata and have not tried other treatments like hair transplants. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you stop using any systemic, topical, or device-based therapy for alopecia areata.

Is there any evidence suggesting that ADX-914 is likely to be safe for humans?

Research has shown that bempikibart (ADX-914) may help treat severe Alopecia Areata, a condition that causes hair loss. Some studies found that this treatment can promote hair regrowth in about 24 weeks. Importantly, the safety data so far suggest it is generally well-tolerated, with no major reports of severe side effects. The FDA has granted the treatment Fast Track designation, indicating its promising safety profile. While potential risks should always be considered, the current data appear encouraging for those considering this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ADX-914 for severe alopecia areata because it offers a new way to tackle this condition. Most treatments for alopecia areata, like corticosteroids and immunosuppressants, work by broadly dampening the immune system. However, ADX-914, also known as bempikibart, works differently by specifically targeting pathways involved in the immune response, potentially reducing hair loss with fewer side effects. Additionally, ADX-914 is administered via an injection under the skin, which might provide a more direct and efficient delivery compared to topical or oral options. This targeted approach could mean more effective and safer treatment for patients suffering from severe alopecia areata.

What evidence suggests that ADX-914 might be an effective treatment for severe Alopecia Areata?

Research shows that bempikibart (ADX-914), which participants in this trial may receive, may help treat severe alopecia areata, a condition causing hair loss. Studies found that patients experienced noticeable hair regrowth within 24 weeks of starting treatment. Specifically, SALT scores, which measure scalp hair loss, decreased, indicating better hair density. The benefits continued even after stopping the medication. These findings suggest that bempikibart could effectively help people with severe hair loss regrow their hair. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with severe Alopecia Areata, having lost hair for more than 6 months but less than 10 years. Participants must have a significant degree of hair loss at the start. Those with other skin conditions, different alopecia types, extreme body weights, scalp treatments like transplants or micropigmentation, recent serious infections or TB can't join.

Inclusion Criteria

My condition is moderate to severe with a SALT score of 50% or higher.

Exclusion Criteria

I have tested positive for TB or have a history of it.

I am using a treatment for alopecia areata.

I have or am at risk of a serious infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive bempikibart (ADX-914) or placebo every 2 weeks for 24 weeks in Part A

24 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment in Part A

12 weeks

Open-label Treatment

Participants receive bempikibart (ADX-914) for 36 weeks in Part B

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment in Part B

16 weeks

Open-label Extension

Participants who experienced hair regrowth in Part A receive bempikibart (ADX-914) for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after the open-label extension

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ADX-914
• Placebo

Trial Overview

The study tests ADX-914 against a placebo in people with severe Alopecia Areata to see if it helps regrow hair. It's randomized (participants are put into groups by chance), double-blind (neither participants nor researchers know who gets what treatment), and placebo-controlled (some get the real drug; others get an inactive substance).

How Is the Trial Designed?

Group I: Experimental: bempikibart (ADX-914) Experimental Treatment 1 Intervention

200mg dose of bempikibart (ADX-914) administered via injection under the skin

Who Is Running the Clinical Trial?

Q32 Bio Inc.

Lead Sponsor

Trials

4

Recruited

210+

Innovaderm Research

Collaborator

Trials

2

Recruited

70+

Innovaderm Research Inc.

Collaborator

Trials

49

Recruited

3,200+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06018428

A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX- ...

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.

2.

hcplive.com

hcplive.com/view/late-breaking-data-bempikibart-severe-alopecia-areata-with-brett-king-md-phd

Late-Breaking Data on Bempikibart for Severe Alopecia ...

The findings from the SIGNAL-AA phase 2a study on bempikibart, a drug formerly known as ADX-914, highlight the medication's efficacy among patients.

3.

ir.q32bio.com

ir.q32bio.com/news-releases/news-release-details/q32-bio-presents-results-signal-aa-part-clinical-trial

Q32 Bio Presents Results from SIGNAL-AA Part A Clinical ...

Results presented in AAD late-breaker demonstrate bempikibart's encouraging improvement on SALT reduction at week 24 and continued effects after dosing ...

4.

naaf.org

naaf.org/studies/adx-914-alopeciaareata/

Open Label Phase 2a, Proof-of-Concept Trial ...

The purpose of the study is to evaluate how effective injections of the investigational drug called bempikibart (ADX-914) are on reducing hair loss in patients ...

5.

healio.com

healio.com/news/dermatology/20250310/bempikibart-may-incite-hair-regrowth-after-treatment-cessation-in-severe-alopecia-areata

Bempikibart may incite hair regrowth after treatment ...

Patients with severe to very severe alopecia areata saw hair regrowth with bempikibart treatment within 24 weeks. Hair regrowth seemed to ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06018428

A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX- ...

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.

7.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/424015

A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX- ...

Part B is a multicenter, open-label study to assess the efficacy, safety, and tolerability of bempikibart (ADX-914) in participants with severe ...

8.

dermatologytimes.com

dermatologytimes.com/view/q32-bio-s-bempikibart-receives-fda-fast-track-designation-for-alopecia-areata

Q32 Bio's Bempikibart Receives FDA Fast Track ...

The United States Food and Drug Administration (FDA) has granted Fast Track designation for bempikibart (ADX-914), which is used for the treatment of severe ...