What side effects are associated with this type of intervention?

Common treatments for alopecia areata, particularly JAK inhibitors like tofacitinib, can have several side effects. Tofacitinib may cause diarrhea, liver enzyme elevation, pancreatitis, and bone marrow suppression, which can lead to treatment cessation. Other treatments, such as topical corticosteroids, can cause skin thinning and irritation. Methotrexate, another systemic treatment, may lead to liver toxicity, bone marrow suppression, and gastrointestinal issues. Cyclosporine, while effective, is associated with serious adverse effects like hypertension and kidney damage, limiting its long-term use. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved baricitinib, a selective Janus kinase (JAK) 1 and JAK 2 inhibitor, for the treatment of severe alopecia areata in adults. Baricitinib has demonstrated efficacy in phase 3 trials, showing superiority over placebo in achieving significant hair regrowth. Other JAK inhibitors, such as tofacitinib and ruxolitinib, have shown promise in clinical studies but are not yet FDA-approved specifically for alopecia areata. These treatments work by modulating the immune response, which is a key factor in the pathogenesis of alopecia areata.

What other types of research exist?

Promising novel alternatives to JAK inhibitors for Alopecia Areata patients include Dupilumab, which has shown potential benefits in clinical trials and case reports, and ADX-914, currently in a Phase IIa trial.

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ADX-914 for Severe Alopecia Areata (SIGNAL-AA Trial)

Q: What is the mechanism of action of this treatment?

Alopecia Areata is an autoimmune condition where the immune system attacks hair follicles, leading to hair loss. The most common treatments aim to modulate the immune response to prevent this attack. JAK inhibitors, such as tofacitinib and ruxolitinib, work by inhibiting Janus Kinase enzymes, which play a crucial role in the signaling pathways that lead to inflammation and immune responses. By blocking these enzymes, JAK inhibitors can reduce the immune system's attack on hair follicles, promoting hair regrowth. Other treatments include corticosteroids, which suppress overall immune activity, and topical immunotherapies like DPCP and SADBE, which aim to redirect the immune response away from hair follicles. Understanding these mechanisms is vital for patients as it helps them make informed decisions about their treatment options and manage expectations regarding efficacy and potential side effects.

Phase 2

Waitlist Available

Research Sponsored by Q32 Bio Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate to severe disease activity at baseline and screening defined as SALT score ≥ 50%

Age 18 to 75 years, inclusive, at time of informed consent, with severe AA (duration of current episode of hair loss >6 months and <10 years)

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

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.

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

Potential side effects of ADX-914 aren't specified here but could include reactions similar to other medications treating skin conditions such as redness, itching, or irritation at the application site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

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I am between 18 and 75 years old and have had severe alopecia areata for more than 6 months but less than 10 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am using a treatment for alopecia areata.

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I have or am at risk of a serious infection.

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

Select...

I have been diagnosed with a type of hair loss other than male or female pattern baldness.

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My weight is either below 48 kg or above 105 kg.

Select...

I have significant hair loss beyond early stages.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental: ADX-914Experimental Treatment1 Intervention

200mg dose of ADX-914 administered via injection under the skin every 2 weeks for a total of 24 weeks.

Group II: Placebo ComparatorPlacebo Group1 Intervention

ADX-914 matched placebo administered via injection under the skin every 2 weeks for a total of 24 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ADX-914

2020

Completed Phase 1

~50

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Alopecia Areata is an autoimmune condition where the immune system attacks hair follicles, leading to hair loss. The most common treatments aim to modulate the immune response to prevent this attack. JAK inhibitors, such as tofacitinib and ruxolitinib, work by inhibiting Janus Kinase enzymes, which play a crucial role in the signaling pathways that lead to inflammation and immune responses. By blocking these enzymes, JAK inhibitors can reduce the immune system's attack on hair follicles, promoting hair regrowth. Other treatments include corticosteroids, which suppress overall immune activity, and topical immunotherapies like DPCP and SADBE, which aim to redirect the immune response away from hair follicles. Understanding these mechanisms is vital for patients as it helps them make informed decisions about their treatment options and manage expectations regarding efficacy and potential side effects.