What side effects are associated with this type of intervention?

Common treatments for Alopecia Areata, particularly those similar to Deucravacitinib (a selective TYK2 inhibitor), include JAK inhibitors like tofacitinib and immunosuppressants such as methotrexate and cyclosporine. Known side effects of JAK inhibitors can include increased risk of infections, liver enzyme elevation, and gastrointestinal issues. Methotrexate may cause liver toxicity, bone marrow suppression, and gastrointestinal discomfort. Cyclosporine is associated with serious adverse effects like nephrotoxicity, hypertension, and increased risk of infections, which often preclude its long-term use.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Alopecia Areata. However, several JAK inhibitors, such as tofacitinib and ruxolitinib, have shown promise in clinical studies for treating this condition. These drugs work by modulating the immune response, similar to the mechanism of action of Deucravacitinib, a selective TYK2 inhibitor currently under investigation. While these treatments are not yet FDA-approved for Alopecia Areata, ongoing research and clinical trials continue to explore their efficacy and safety.

What other types of research exist?

Promising alternatives to Deucravacitinib for Alopecia Areata include Tofacitinib and Dupilumab. Tofacitinib 2% ointment has shown hair regrowth in both adults and children with Alopecia Areata, Alopecia Totalis, or Alopecia Universalis. Dupilumab has demonstrated potential benefits in a phase 2 trial, with some patients achieving significant improvement in the SALT score after 24 weeks of treatment.

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Janus Kinase (JAK) Inhibitor

Deucravacitinib for Alopecia Areata

Phase 2

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

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

Must have

Documented clinical diagnosis of Alopecia Areata (AA) for at least 6 months

Be older than 18 years old

Must not have

Participant with diffuse-type AA or other forms of hair loss, including traction alopecia, lichen planopilaris, central centrifugal cicatricial alopecia, frontal fibrosing alopecia, etc

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a medication called Deucravacitinib to see if it can help adults with Alopecia Areata, a condition where people lose hair in patches. The study will compare the effects of Deucravacitinib to another treatment over several months. The goal is to find out if the medication is effective and safe.

Who is the study for?

This trial is for adults with Alopecia Areata who've had the condition for at least 6 months, with current hair loss affecting over half their scalp and stable for the past 6 months. They should have a SALT score of at least 50, indicating significant hair loss. Those with other types of hair loss or skin conditions that could affect scalp assessment can't participate.

What is being tested?

The study is testing Deucravacitinib's effectiveness compared to a placebo in improving symptoms by Week 24. Participants will be randomly assigned to receive either Deucravacitinib or a placebo, allowing researchers to measure the drug's true impact on Alopecia Areata.

What are the potential side effects?

While specific side effects are not listed here, participants may experience adverse reactions related to Deucravacitinib which will be closely monitored against those taking the placebo for safety and tolerability.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with Alopecia Areata for at least 6 months.

Exclusion Criteria

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

Select...

I have a type of hair loss such as diffuse AA or traction alopecia.

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

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Deucravacitinib Dose 2Experimental Treatment2 Interventions

Group II: Deucravacitinib Dose 1Experimental Treatment2 Interventions

Group III: Placebo, followed by Deucravacitinib Dose 1 or Dose 2.Placebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Deucravacitinib

2021

Completed Phase 4

~160

0 / 2Eligibility 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 primarily driven by an autoimmune response where cytotoxic T lymphocytes attack hair follicles. Treatments like Deucravacitinib, a selective TYK2 inhibitor, work by modulating the immune system to reduce this inflammatory response. Similar treatments include JAK inhibitors like tofacitinib and ruxolitinib, which also target pathways involved in immune signaling to prevent hair follicle destruction. Other common treatments, such as corticosteroids and immunosuppressants like methotrexate and cyclosporine, broadly suppress the immune system to reduce inflammation. Understanding these mechanisms is crucial for patients, as it helps them grasp how these treatments can potentially halt or reverse hair loss by addressing the underlying immune dysfunction.