ADX-914 for Severe Alopecia Areata

(SIGNAL-AA Trial)

Recruiting at 18 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

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests ADX-914, an injectable medication, in adults with severe hair loss due to Alopecia Areata. The treatment likely works by calming the immune system to help hair grow back. Delgocitinib has shown effectiveness in other inflammatory skin conditions and is being explored for its potential in treating alopecia areata.

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.

What makes the drug ADX-914 unique for treating severe alopecia areata?

The drug ADX-914 is unique because it involves the use of monoclonal antibodies targeting CD4+ cells, which are important in immune system regulation. This approach is different from other treatments for alopecia areata, as it specifically modulates immune cell activity, potentially offering a novel way to manage the condition. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

In vivo administration of anti-CD4 monoclonal antibody prolongs survival in longtailed macaques with experimental allergic encephalomyelitis. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The new orally active immunoregulator laquinimod (ABR-215062) effectively inhibits development and relapses of experimental autoimmune encephalomyelitis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment of spontaneous EAE by laquinimod reduces Tfh, B cell aggregates, and disease progression. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Laquinimod (ABR-215062) suppresses the development of experimental autoimmune encephalomyelitis, modulates the Th1/Th2 balance and induces the Th3 cytokine TGF-beta in Lewis rats. [2012]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Laquinimod modulates B cells and their regulatory effects on T cells in multiple sclerosis. [2022]