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Dihydroorotate Dehydrogenase Inhibitor
Farudodstat 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment start to week 28
Awards & highlights
FAST-AA Trial Summary
This trial will measure if a drug can help adults with Alopecia Areata regain lost hair on their scalp.
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.Check my eligibility
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.See study design
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.
FAST-AA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ treatment start to week 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment start to week 28
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreFAST-AA 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
Find a Location
Who is running the clinical trial?
ASLAN PharmaceuticalsLead Sponsor
20 Previous Clinical Trials
1,450 Total Patients Enrolled
Chief Medical OfficerStudy DirectorASLAN Pharmaceuticals
123 Previous Clinical Trials
21,634 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.I have severe hair loss due to Alopecia Areata with no other cause, losing at least 30% of my scalp hair for 6 months to 7 years without improvement.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 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Alopecia Areata Patient Testimony for trial: Trial Name: NCT05865041 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this treatment bring any potential health risks for patients?
"The safety of this medication has been preliminarily assessed at a 2, as the Phase 2 trial did not have any efficacy data to review."
Answered by AI
Are new participants still able to join this clinical research?
"According to the clinicaltrials.gov page, this trial is currently open for applications. It was initially posted on April 14th 2023 and its details were recently updated on June 5th of the same year."
Answered by AI
What is the anticipated enrollment rate for this clinical trial?
"Yes, according to clinicaltrials.gov, this medical study is still recruiting participants. It was first listed on April 14th of 2023 and has since been edited as recent as June 5th of the same year. In total, 60 patients need to be recruited from twenty different facilities."
Answered by AI
In which states is this research study being conducted?
"Currently, 20 medical centres across the country are enrolling patients. These include Fountain Valley, Nashville and San Diego, in addition to other cities. Choosing a clinic nearby can help minimize any travel requirements for participants who join this trial."
Answered by AI
Who else is applying?
What state do they live in?
Texas
New York
What site did they apply to?
1 Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
Would like to see if I meet quilifcations. Hoping to understand and provide further information / data related to AA.
PatientReceived 1 prior treatment
I have been dealing with on/off Alopecia for 8 years but it has progressed in the last year with no improvement.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- 1 Site: < 48 hours
Average response time
- < 2 Days
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