Farudodstat Tablets for Alopecia Areata

(FAST-AA Trial)

Recruiting at 20 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called farudodstat for people with Alopecia Areata (AA), a condition that causes hair loss. The goal is to determine if farudodstat can regrow hair on the scalp compared to a placebo (a pill with no active medicine) over 12 weeks. Participants will receive either farudodstat or a placebo for 12 weeks, then switch to the other treatment for another 12 weeks. Ideal participants are adults who have lost at least 30% of their scalp hair due to AA for at least six months but not more than seven years. As a Phase 2 trial, this research measures how well farudodstat works in an initial, smaller group of people, offering participants a chance to contribute to potential advancements in AA treatment.

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.

Is there any evidence suggesting that farudodstat is likely to be safe for humans?

Research has shown that farudodstat has been generally well-tolerated in previous studies. No new concerns about liver health or other safety issues have emerged. This conclusion arises from a review of safety data, which found no major side effects linked to its use. Although no treatment is entirely risk-free, current evidence suggests that farudodstat is safe for use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alopecia areata?

Unlike the standard treatments for alopecia areata, which mainly include corticosteroids and immunotherapy, Farudodstat offers a novel approach by targeting a different pathway. Researchers are excited about Farudodstat because it works by inhibiting an enzyme called Janus kinase (JAK), which plays a crucial role in the immune response that causes hair loss. This new mechanism of action may lead to more effective and targeted results. Additionally, Farudodstat is administered in a simple oral form, making it potentially more convenient than some existing treatments that require injections or topical applications. These unique features could offer new hope for people with alopecia areata looking for more effective and user-friendly options.

What evidence suggests that farudodstat might be an effective treatment for Alopecia Areata?

Research shows that farudodstat may help treat alopecia areata, a condition that causes hair loss. Previous studies suggest that farudodstat might protect hair follicles by shielding them from the immune system, thereby preventing hair loss. In some trials, participants experienced significant hair regrowth, achieving a 75% improvement in scalp condition within 12 weeks. In this trial, participants will receive either farudodstat for 12 weeks followed by a placebo for 12 weeks, or a placebo for 12 weeks followed by farudodstat for 12 weeks. While these results are promising, more information is needed to fully understand its effectiveness. ^{1 3 4 5 6}

Who Is on the Research Team?

Chief Medical Officer

Principal Investigator

ASLAN Pharmaceuticals

Are You a Good Fit for This Trial?

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)?

Are you willing to have mandatory photos taken?

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

Exclusion Criteria

History or presence of hair transplants

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05865041

Study: Farudodstat vs Placebo for Alopecia Areata The main purpose of this study is to measure the efficacy of farudodstat compared to placebo at Week 12 from the treatment start, in adult participants with ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/414097

Investigate the Efficacy and Safety of Farudodstat ... The main purpose of this study is to measure the efficacy of farudodstat compared to placebo at Week 12 from the treatment start, ...

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/aslan-alopecia-areata-therapy/

ASLAN doses first subject in alopecia areata therapy trial The trial will examine the efficacy and safety of farudodstat in patients who have lost at least 50% of their scalp hair.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05865041?term=alopecia&viewType=Table&rank=9

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

5. biospace.com biospace.com/aslan-pharmaceuticals-provides-year-end-update-on-its-eblasakimab-and-farudodstat-programs

ASLAN Pharmaceuticals Provides Year-End Update on Its ... ASLAN has generated data showing that farudodstat can potentially protect against the loss of immune privilege in hair follicles, supporting ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05865041?cond=Alopecia%20Areata%20&viewType=Table&rank=10

Investigate the Efficacy and Safety of Farudodstat ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...