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

Primary Purpose

Alopecia Areata

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Farudodstat
Placebo
Sponsored by
ASLAN Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring farudodstat, alopecia areata, DHODH inhibitor, ASLAN003

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult (≥18 years of age and a weight of ≥40 kg at the time of signing the informed consent) Has severe or very severe Alopecia Areata (AA), as determined by meeting the following criteria: Clinical diagnosis of AA with no other etiology of hair loss (e.g., telogen effluvium, androgenetic alopecia, etc.) At least 50% scalp hair loss, as defined by a SALT score ≥50 Current episode of hair loss lasting at least 6 months and not exceeding 7 years at the time of Screening. Participants who have severe or very severe 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 No appreciable change (i.e., change exceeding 20 points on SALT score) in terminal hair regrowth within 6 months Exclusion Criteria: Has known history of androgenic alopecia or female pattern hair loss prior to AA Has other types of alopecia (including, but not limited to traction and scarring alopecia, telogen effluvium, diffuse type of AA) Has history or presence of hair transplants Has other scalp disease that may impact AA assessment or require topical treatment (including, but not limited to scalp psoriasis, seborrheic dermatitis, actinic keratosis)

Sites / Locations

  • 1 SiteRecruiting
  • 1 SiteRecruiting
  • 1 SiteRecruiting
  • 1 SiteRecruiting
  • 1 SiteRecruiting
  • 1 SiteRecruiting
  • 1 SiteRecruiting
  • 1 SiteRecruiting
  • 1 SiteRecruiting
  • 1 Site
  • 1 SiteRecruiting
  • 1 SiteRecruiting
  • 1 SiteRecruiting
  • 1 Site
  • 1 SiteRecruiting
  • 1 SiteRecruiting
  • 1 SiteRecruiting
  • 2 SitesRecruiting
  • 1 SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Farudodstat for 12 weeks followed by placebo for 12 weeks

Placebo for 12 weeks followed by farudodstat for 12 weeks

Arm Description

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

Matching Placebo twice daily for 12 weeks followed by farudodstat 100mg twice daily for 12 weeks

Outcomes

Primary Outcome Measures

Percentage of change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.
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).
Incidence of adverse events (AEs) up to Week 28
Number of participants with clinically significant laboratory parameters
Number of participants with clinically significant Electrocardiogram (ECG) parameters

Secondary Outcome Measures

Change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.
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).
Proportion of participants achieving Severity of Alopecia Tool (SALT) ≤20 at Week 12 from the treatment start.
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).
Proportion of participants achieving 50% Improvement of Severity of Alopecia Tool (SALT) (SALT50) at Week 12 from the treatment start.
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).
Time to Severity of Alopecia Tool (SALT) score improvement of 50% by Week 12 from the treatment start.
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).
Proportion of participants achieving 75% Improvement of Severity of Alopecia Tool (SALT) (SALT75) at Week 12 from the treatment start.
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).
Time to Severity of Alopecia Tool (SALT) score improvement of 75% by Week 12 from the treatment start.
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).
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.
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
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.
ClinRO is scored from 0 to 3 with the 3 representing the most eyebrow hair loss.
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.
ClinRO is scored from 0 to 3 with the 3 representing the most eyelash hair loss.
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.
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.
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.
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.
Proportion of participants achieving any amount of hair regrowth at Week 12 after treatment start among participants with alopecia totalis/alopecia universalis (AT/AU)

Full Information

First Posted
April 15, 2023
Last Updated
July 10, 2023
Sponsor
ASLAN Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05865041
Brief Title
Investigate the Efficacy and Safety of Farudodstat Compared With Its Placebo in Adult Alopecia Areata Participants
Acronym
FAST-AA
Official Title
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 50% or Greater Scalp Hair Loss
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
February 20, 2024 (Anticipated)
Study Completion Date
April 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ASLAN Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 50% or greater scalp hair loss.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
farudodstat, alopecia areata, DHODH inhibitor, ASLAN003

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Approximately 60 participants will be randomized in a 2:1 ratio into one of two treatment sequences: Farudodstat 100mg twice daily for 12 weeks followed by 12 weeks of placebo twice daily Placebo twice daily for the first 12 weeks followed by farudodstat 100mg twice daily for 12 weeks
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Farudodstat for 12 weeks followed by placebo for 12 weeks
Arm Type
Experimental
Arm Description
Farudodstat 100mg twice daily for 12 weeks followed by matching Placebo twice daily for 12 weeks
Arm Title
Placebo for 12 weeks followed by farudodstat for 12 weeks
Arm Type
Experimental
Arm Description
Matching Placebo twice daily for 12 weeks followed by farudodstat 100mg twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Farudodstat
Other Intervention Name(s)
ASLAN003
Intervention Description
Farudodstat tablets administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Comparator
Intervention Description
Placebo tablets administered orally
Primary Outcome Measure Information:
Title
Percentage of change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.
Description
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).
Time Frame
Treatment Start to Week 12
Title
Incidence of adverse events (AEs) up to Week 28
Time Frame
Treatment Start to Week 28
Title
Number of participants with clinically significant laboratory parameters
Time Frame
Treatment Start to Week 28
Title
Number of participants with clinically significant Electrocardiogram (ECG) parameters
Time Frame
Treatment Start to Week 28
Secondary Outcome Measure Information:
Title
Change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start.
Description
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).
Time Frame
Treatment Start to Week 12
Title
Proportion of participants achieving Severity of Alopecia Tool (SALT) ≤20 at Week 12 from the treatment start.
Description
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).
Time Frame
Treatment Start to Week 12
Title
Proportion of participants achieving 50% Improvement of Severity of Alopecia Tool (SALT) (SALT50) at Week 12 from the treatment start.
Description
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).
Time Frame
Treatment Start to Week 12
Title
Time to Severity of Alopecia Tool (SALT) score improvement of 50% by Week 12 from the treatment start.
Description
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).
Time Frame
Treatment Start to Week 12
Title
Proportion of participants achieving 75% Improvement of Severity of Alopecia Tool (SALT) (SALT75) at Week 12 from the treatment start.
Description
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).
Time Frame
Treatment Start to Week 12
Title
Time to Severity of Alopecia Tool (SALT) score improvement of 75% by Week 12 from the treatment start.
Description
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).
Time Frame
Treatment Start to Week 12
Title
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.
Description
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
Time Frame
Treatment Start to Week 12
Title
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.
Description
ClinRO is scored from 0 to 3 with the 3 representing the most eyebrow hair loss.
Time Frame
Treatment Start to Week 12
Title
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.
Description
ClinRO is scored from 0 to 3 with the 3 representing the most eyelash hair loss.
Time Frame
Treatment Start to Week 12
Title
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.
Description
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.
Time Frame
Treatment Start to Week 12
Title
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.
Description
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.
Time Frame
Treatment Start to Week 12
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (≥18 years of age and a weight of ≥40 kg at the time of signing the informed consent) Has severe or very severe Alopecia Areata (AA), as determined by meeting the following criteria: Clinical diagnosis of AA with no other etiology of hair loss (e.g., telogen effluvium, androgenetic alopecia, etc.) At least 50% scalp hair loss, as defined by a SALT score ≥50 Current episode of hair loss lasting at least 6 months and not exceeding 7 years at the time of Screening. Participants who have severe or very severe 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 No appreciable change (i.e., change exceeding 20 points on SALT score) in terminal hair regrowth within 6 months Exclusion Criteria: Has known history of androgenic alopecia or female pattern hair loss prior to AA Has other types of alopecia (including, but not limited to traction and scarring alopecia, telogen effluvium, diffuse type of AA) Has history or presence of hair transplants Has other scalp disease that may impact AA assessment or require topical treatment (including, but not limited to scalp psoriasis, seborrheic dermatitis, actinic keratosis)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ASLAN Pharmaceuticals
Phone
+65 6817 9598
Email
contact@aslanpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
ASLAN Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
1 Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
2 Sites
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com
Facility Name
1 Site
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Email
fastaa@aslanpharma.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigate the Efficacy and Safety of Farudodstat Compared With Its Placebo in Adult Alopecia Areata Participants

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