ADX-914 for Severe Alopecia Areata
(SIGNAL-AA Trial)
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.12345
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.35678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive bempikibart (ADX-914) or placebo every 2 weeks for 24 weeks in Part A
Follow-up
Participants are monitored for safety and effectiveness after treatment in Part A
Open-label Treatment
Participants receive bempikibart (ADX-914) for 36 weeks in Part B
Follow-up
Participants are monitored for safety and effectiveness after treatment in Part B
Open-label Extension
Participants who experienced hair regrowth in Part A receive bempikibart (ADX-914) for 6 months
Follow-up
Participants are monitored for safety and effectiveness after the open-label extension
What Are the Treatments Tested in This Trial?
Interventions
- ADX-914
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Q32 Bio Inc.
Lead Sponsor
Innovaderm Research
Collaborator
Innovaderm Research Inc.
Collaborator