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Dihydroorotate Dehydrogenase Inhibitor
Farudodstat Tablets for Alopecia Areata (FAST-AA Trial)
Phase 2
Recruiting
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 belowTimeline
Screening ~ 35 days1 visit
Treatment ~ 24 weeks9 visits
Follow Up ~ 4 weeks1 visit
Screening ~ 35 days
Treatment ~ 24 weeks
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.
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.
+8 moreTrial 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
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?
Case Report: Successful Treatment of Alopecia Universalis With Tofacitinib and Increased Cytokine Levels: Normal Therapeutic Reaction or Danger Signal?
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
ASLAN PharmaceuticalsLead Sponsor
20 Previous Clinical Trials
1,450 Total Patients Enrolled
Chief Medical OfficerStudy DirectorASLAN Pharmaceuticals
129 Previous Clinical Trials
22,025 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with alopecia areata and no other cause for my hair loss.There is not enough improvement in hair regrowth within 6 months.I have a type of hair loss that is not common baldness.I had hair loss patterns related to hormones before my alopecia areata.I do not have any scalp conditions that could affect hair loss evaluation.I am 18 or older and weigh at least 40 kg.My current episode of hair loss has been ongoing for 6 months to 7 years.I have severe hair loss due to Alopecia Areata.I have lost more than half of my scalp hair.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo for 12 weeks followed by farudodstat for 12 weeks
- Group 2: Farudodstat for 12 weeks followed by placebo for 12 weeks
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 35 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 24 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 4 Weeks after you stop receiving the treatment.
Alopecia Areata Patient Testimony for trial: Trial Name: NCT05865041 — Phase 2