Investigate the Efficacy and Safety of Farudodstat Compared With Its Placebo in Adult Alopecia Areata Participants
NCT ID: NCT05865041
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2023-04-14
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
* Sequence one: Farudodstat 100mg twice daily for 12 weeks followed by placebo twice daily for 12 weeks
* Sequence two: Placebo twice daily for 12 weeks followed by farudodstat 100mg twice daily for 12 weeks
TREATMENT
QUADRUPLE
Study Groups
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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
Farudodstat
Farudodstat tablets administered orally
Placebo
Placebo tablets administered orally
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
Farudodstat
Farudodstat tablets administered orally
Placebo
Placebo tablets administered orally
Interventions
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Farudodstat
Farudodstat tablets administered orally
Placebo
Placebo tablets administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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ASLAN Pharmaceuticals
OTHER
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_DIRECTOR
ASLAN Pharmaceuticals
Locations
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1 Site
Birmingham, Alabama, United States
1 Site
Fountain Valley, California, United States
1 Site
Santa Ana, California, United States
1 Site
New Haven, Connecticut, United States
1 Site
Washington D.C., District of Columbia, United States
1 Site
Coral Gables, Florida, United States
1 Site
Indianapolis, Indiana, United States
1 Site
Louisville, Kentucky, United States
1 Site
Brighton, Massachusetts, United States
1 Site
Minneapolis, Minnesota, United States
1 Site
New Brighton, Minnesota, United States
1 Site
Saint Joseph, Missouri, United States
1 Site
Omaha, Nebraska, United States
1 Site
Cleveland, Ohio, United States
1 Site
Columbus, Ohio, United States
1 Site
Nashville, Tennessee, United States
1 Site
Pflugerville, Texas, United States
2 Sites
San Antonio, Texas, United States
1 Site
Webster, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Role: primary
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Other Identifiers
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ASLAN003-004
Identifier Type: -
Identifier Source: org_study_id