Investigate the Efficacy and Safety of Farudodstat Compared With Its Placebo in Adult Alopecia Areata Participants (FAST-AA)

December 12, 2023 updated by: ASLAN Pharmaceuticals

A Parallel Group Treatment, Phase 2a, Double-blind, Two-arm Study to Investigate the Efficacy and Safety of Farudodstat Tablets Compared With Its Placebo in Male or Female Alopecia Areata Participants Aged 18 Years and Older With 30% or Greater Scalp Hair Loss

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 Alopecia Areata (AA) with 30% or greater scalp hair loss.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult (≥18 years of age and a weight of ≥40 kg at the time of signing the informed consent)

  • Moderate, severe, or very severe Alopecia Areata (AA), as determined by meeting the following criteria:

    1. Clinical diagnosis of AA with no other etiology of hair loss (e.g., telogen effluvium, androgenetic alopecia, etc.)
    2. At least 30% scalp hair loss, as defined by a SALT score ≥30
    3. Current episode of hair loss lasting at least 6 months and not exceeding 7 years at the time of Screening. Participants who have AA for longer than 7 years may be enrolled if episodes of regrowth, spontaneous or under treatment, have been observed on the affected areas over the past 7 years
    4. No appreciable change (i.e., change exceeding 20 points on SALT score) in terminal hair regrowth within 6 months

Exclusion Criteria:

  • Known history of androgenic alopecia or female pattern hair loss prior to AA
  • Other types of alopecia (including, but not limited to traction and scarring alopecia, telogen effluvium, diffuse type of AA)
  • History or presence of hair transplants
  • Other scalp disease that may impact AA assessment or require topical treatment (including, but not limited to scalp psoriasis, seborrheic dermatitis, actinic keratosis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Farudodstat for 12 weeks followed by placebo for 12 weeks
Farudodstat 100mg twice daily for 12 weeks followed by matching Placebo twice daily for 12 weeks
Drug: Placebo
Placebo tablets administered orally
Other Names:
  • Placebo Comparator
Drug: Farudodstat
Farudodstat tablets administered orally
Other Names:
  • ASLAN003
Experimental: Placebo for 12 weeks followed by farudodstat for 12 weeks
Matching Placebo twice daily for 12 weeks followed by farudodstat 100mg twice daily for 12 weeks
Drug: Placebo
Placebo tablets administered orally
Other Names:
  • Placebo Comparator
Drug: Farudodstat
Farudodstat tablets administered orally
Other Names:
  • ASLAN003

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.
Time Frame: Treatment Start to Week 12
The Severity of Alopecia Tool (SALT) is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Treatment Start to Week 12
Incidence of adverse events (AEs) up to Week 28
Time Frame: Treatment Start to Week 28
Treatment Start to Week 28
Number of participants with clinically significant laboratory parameters
Time Frame: Treatment Start to Week 28
Treatment Start to Week 28
Number of participants with clinically significant Electrocardiogram (ECG) parameters
Time Frame: Treatment Start to Week 28
Treatment Start to Week 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.
Time Frame: Treatment Start to Week 12
The Severity of Alopecia Tool (SALT) is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Treatment Start to Week 12
Proportion of participants achieving Severity of Alopecia Tool (SALT) ≤20 at Week 12 from the treatment start.
Time Frame: Treatment Start to Week 12
The Severity of Alopecia Tool (SALT) is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Treatment Start to Week 12
Proportion of participants achieving 50% Improvement of Severity of Alopecia Tool (SALT) (SALT50) at Week 12 from the treatment start.
Time Frame: Treatment Start to Week 12
The Severity of Alopecia Tool (SALT) is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Treatment Start to Week 12
Time to Severity of Alopecia Tool (SALT) score improvement of 50% by Week 12 from the treatment start.
Time Frame: Treatment Start to Week 12
The Severity of Alopecia Tool (SALT) is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Treatment Start to Week 12
Proportion of participants achieving 75% Improvement of Severity of Alopecia Tool (SALT) (SALT75) at Week 12 from the treatment start.
Time Frame: Treatment Start to Week 12
The Severity of Alopecia Tool (SALT) is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Treatment Start to Week 12
Time to Severity of Alopecia Tool (SALT) score improvement of 75% by Week 12 from the treatment start.
Time Frame: Treatment Start to Week 12
The Severity of Alopecia Tool (SALT) is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).
Treatment Start to Week 12
Proportion of participants with Scalp Hair Assessment Patient Reported Outcome (PRO)™ score of 0 or 1 with a ≥2-point improvement at Week 12 from the treatment start among participants with a score of ≥3 at baseline.
Time Frame: Treatment Start to Week 12
Participants will assess the severity of their scalp hair loss using 5-point Scalp Hair Assessment PRO™️ scale (0-4) with 4 being the most scalp hair loss
Treatment Start to Week 12
Proportion of participants achieving Clinician Reported Outcome (ClinRO) measure for Eyebrow Hair Loss™ 0 or 1 with ≥2-point improvement from baseline (Among Participants with scores ≥2 at Baseline) at Week 12 from the treatment start.
Time Frame: Treatment Start to Week 12
ClinRO is scored from 0 to 3 with the 3 representing the most eyebrow hair loss.
Treatment Start to Week 12
Proportion of participants achieving Clinician Reported Outcome (ClinRO) measure for Eyelash Hair Loss™ 0 or 1 with ≥2-point improvement from baseline (among participants with scores ≥2 at baseline) at Week 12 from the treatment start.
Time Frame: Treatment Start to Week 12
ClinRO is scored from 0 to 3 with the 3 representing the most eyelash hair loss.
Treatment Start to Week 12
Proportion of participants achieving Patient Reported Outcome (PRO) Measure for Eyebrows™ 0 or 1 with ≥2-point improvement from baseline (among participants with scores ≥2 at baseline) at Week 12 from the treatment start.
Time Frame: Treatment Start to Week 12
Patient's self-assessment of the overall severity of eyebrow hair loss is measured by a 4-point scale (0-3) with photoguide with 3 being the most eyebrow hair loss.
Treatment Start to Week 12
Proportion of participants achieving any amount of hair regrowth at Week 12 after treatment start among participants with alopecia totalis/alopecia universalis (AT/AU)
Time Frame: Treatment Start to Week 12
Treatment Start to Week 12
Proportion of participants achieving Patient Reported Outcome (PRO) Measure for Eyelashes™ 0 or 1 with ≥2-point improvement from baseline (among participants with scores ≥2 at Baseline) at Week 12 from the treatment start.
Time Frame: Treatment Start to Week 12
Patient's self-assessment of the overall severity of eyelash hair loss is measured by a 4-point scale (0-3) with photoguide with 3 being the most eyelash hair loss.
Treatment Start to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASLAN Pharmaceuticals

Investigators

  • Study Director: Chief Medical Officer, ASLAN Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2023

Primary Completion (Estimated)

September 12, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

April 15, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASLAN003-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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