What side effects are associated with this type of intervention?

Common treatments for Alopecia Areata, particularly JAK inhibitors like tofacitinib and baricitinib, can have side effects such as increased risk of infections, elevated liver enzymes, and changes in blood counts. Other immunosuppressive treatments, such as methotrexate and cyclosporine, may cause liver toxicity, bone marrow suppression, and kidney dysfunction. Topical treatments like corticosteroids can lead to skin thinning and irritation. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for Alopecia Areata, including JAK inhibitors like baricitinib, which is used for moderate to severe cases. Baricitinib, an oral JAK1/JAK2 inhibitor, has shown efficacy in clinical trials for Alopecia Areata, similar to the investigational drug Farudodstat. Other treatments include topical and systemic corticosteroids, immunosuppressants like methotrexate and cyclosporine, and topical immunotherapy agents such as diphenylcyclopropenone (DPCP) and squaric acid dibutyl ester (SADBE). These treatments aim to modulate the immune response to promote hair regrowth.

What other types of research exist?

Promising novel alternatives to Farudodstat for Alopecia Areata patients include: 1) Tofacitinib 2% ointment, which has shown hair regrowth in both adults and children with refractory alopecia areata. 2) Dupilumab, which has demonstrated some benefit in clinical trials and case reports, particularly in patients with higher baseline serum IgE levels and a history of atopy.

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Dihydroorotate Dehydrogenase Inhibitor

Farudodstat Tablets for Alopecia Areata (FAST-AA Trial)

Phase 2

Waitlist Available

Research Sponsored by ASLAN Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Are you at least 18 years old?

Do you have at least 30% scalp hair loss?

Timeline

Screening 35 days

Treatment 24 weeks

Follow Up 4 weeks

Summary

This trial is testing farudodstat, a medication that may help people with significant hair loss due to Alopecia Areata. The study focuses on adults who have lost 30% or more of their scalp hair. Farudodstat works by influencing body processes that control hair growth.

Who is the study for?

Adults over 18 years old with severe Alopecia Areata (AA) and at least 50% scalp hair loss can join this trial. They should have had AA for no more than 7 years, unless they've seen hair regrowth in that time. People are excluded if they have other types of alopecia, a history of certain hair conditions or treatments, or scalp diseases affecting assessment.

What is being tested?

The study is testing the effectiveness and safety of Farudodstat against a placebo in adults with significant hair loss from AA. The main goal is to see how well it works by week 12 compared to the placebo.

What are the potential side effects?

While specific side effects aren't listed here, participants may experience unexpected reactions to Farudodstat or the placebo. Side effects could range from mild to severe and will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 35 days1 visit

Treatment ~ 24 weeks9 visits

Follow Up ~ 4 weeks1 visit

Screening ~ 35 days

Treatment ~ 24 weeks

Follow Up ~4 weeks

This trial's timeline: 35 days for screening, 24 weeks for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (AEs) up to Week 28

Number of participants with clinically significant Electrocardiogram (ECG) parameters

Number of participants with clinically significant laboratory parameters

+1 more

Secondary study objectives

Change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.

Proportion of participants achieving 50% Improvement of Severity of Alopecia Tool (SALT) (SALT50) at Week 12 from the treatment start.

Proportion of participants achieving 75% Improvement of Severity of Alopecia Tool (SALT) (SALT75) at Week 12 from the treatment start.

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo for 12 weeks followed by farudodstat for 12 weeksExperimental Treatment2 Interventions

Matching Placebo twice daily for 12 weeks followed by farudodstat 100mg twice daily for 12 weeks

Group II: Farudodstat for 12 weeks followed by placebo for 12 weeksExperimental Treatment2 Interventions

Farudodstat 100mg twice daily for 12 weeks followed by matching Placebo twice daily for 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 6Eligibility 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 treatments often target the immune system's role in attacking hair follicles. Selective Janus kinase (JAK) inhibitors, such as tofacitinib and baricitinib, work by blocking the JAK-STAT signaling pathway, which is involved in the inflammatory process that leads to hair loss. This inhibition reduces the immune response against hair follicles, promoting hair regrowth. Other treatments include corticosteroids, which suppress overall immune activity, and topical immunotherapies like diphenylcyclopropenone (DPCP) that modulate local immune responses. Understanding these mechanisms is crucial for patients, as it highlights the importance of targeting specific immune pathways to effectively manage and potentially reverse hair loss in Alopecia Areata.

Case Report: Successful Treatment of Alopecia Universalis With Tofacitinib and Increased Cytokine Levels: Normal Therapeutic Reaction or Danger Signal?