Farudodstat Tablets for Alopecia Areata

(FAST-AA Trial)

Recruiting at 19 trial locations

Overseen By ASLAN Pharmaceuticals

Age: 18+

Sex: Male

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: ASLAN Pharmaceuticals

Disqualifiers: Androgenic alopecia, Hair transplants, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the drug Farudodstat different from other treatments for alopecia areata?

Farudodstat is unique because it may offer a novel approach to treating alopecia areata, potentially targeting the underlying autoimmune mechanisms that cause hair loss, unlike many existing treatments that primarily focus on symptom management. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Chief Medical Officer

Principal Investigator

ASLAN Pharmaceuticals

Eligibility Criteria

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.

Inclusion Criteria

Do you at least weight ≥40kg (approximately 88lbs)?

Do you have Moderate, Severe or Very Severe Alopecia Areata?

Are you willing to have mandatory photos taken?

Exclusion Criteria

I have a type of hair loss that is not common baldness.

I had hair loss patterns related to hormones before my alopecia areata.

History or presence of hair transplants

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either farudodstat or placebo for 12 weeks, followed by a crossover to the alternate treatment for another 12 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Farudodstat
• Placebo

Trial Overview 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.

Participant Groups

Group I: Placebo for 12 weeks followed by farudodstat for 12 weeks Experimental Treatment 2 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 weeks Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

ASLAN Pharmaceuticals

Lead Sponsor

Trials

21

Recruited

1,500+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Treatment of alopecia areata: An Australian expert consensus statement. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Frontal fibrosing alopecia demographics: a survey of 29 patients. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Experience with oral tofacitinib in two adolescents and seven adults with alopecia areata. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Alopecia areata: treatment of today and tomorrow. [2016]

5. Croatia pubmed.ncbi.nlm.nih.gov

Frontal Fibrosing Alopecia: Successfully Treated with Methotrexate or Just the Natural Disease Progression? [2021]