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

Sponsor
ASLAN Pharmaceuticals (Other)
Overall Status
Recruiting
CT.gov ID
NCT05865041
Collaborator
(none)
60
Enrollment
19
Locations
2
Arms
12.2
Anticipated Duration (Months)
3.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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 weeksApproximately 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:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 14, 2023
Anticipated Primary Completion Date :
Feb 20, 2024
Anticipated Study Completion Date :
Apr 18, 2024

Arms and Interventions

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: Farudodstat
Farudodstat tablets administered orally
Other Names:
  • ASLAN003

    • Drug: Placebo
    Placebo tablets administered orally
    Other Names:
  • Placebo Comparator

    		•
    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: Farudodstat
    Farudodstat tablets administered orally
    Other Names:
  • ASLAN003

    • Drug: Placebo
    Placebo tablets administered orally
    Other Names:
  • Placebo Comparator

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start. [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).

    2. Incidence of adverse events (AEs) up to Week 28 [Treatment Start to Week 28]

    3. Number of participants with clinically significant laboratory parameters [Treatment Start to Week 28]

    4. Number of participants with clinically significant Electrocardiogram (ECG) parameters [Treatment Start to Week 28]

    Secondary Outcome Measures

    1. Change from baseline in Severity of Alopecia Tool (SALT) score at Week 12 from the treatment start. [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).

    2. Proportion of participants achieving Severity of Alopecia Tool (SALT) ≤20 at Week 12 from the treatment start. [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).

    3. Proportion of participants achieving 50% Improvement of Severity of Alopecia Tool (SALT) (SALT50) at Week 12 from the treatment start. [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).

    4. Time to Severity of Alopecia Tool (SALT) score improvement of 50% by Week 12 from the treatment start. [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).

    5. Proportion of participants achieving 75% Improvement of Severity of Alopecia Tool (SALT) (SALT75) at Week 12 from the treatment start. [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).

    6. Time to Severity of Alopecia Tool (SALT) score improvement of 75% by Week 12 from the treatment start. [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).

    7. 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. [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

    8. 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. [Treatment Start to Week 12]

      ClinRO is scored from 0 to 3 with the 3 representing the most eyebrow hair loss.

    9. 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. [Treatment Start to Week 12]

      ClinRO is scored from 0 to 3 with the 3 representing the most eyelash hair loss.

    10. 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. [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.

    11. 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. [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.

    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) [Treatment Start to Week 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    1. Clinical diagnosis of AA with no other etiology of hair loss (e.g., telogen effluvium, androgenetic alopecia, etc.)

    2. At least 50% scalp hair loss, as defined by a SALT score ≥50

    3. 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

    4. 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 1 Site Birmingham Alabama United States 35205
    2 1 Site Fountain Valley California United States 92708
    3 1 Site Santa Ana California United States 92701
    4 1 Site New Haven Connecticut United States 06519
    5 1 Site Washington District of Columbia United States 20037
    6 1 Site Coral Gables Florida United States 33134
    7 1 Site Indianapolis Indiana United States 46250
    8 1 Site Louisville Kentucky United States 40241
    9 1 Site Brighton Massachusetts United States 02135
    10 1 Site Minneapolis Minnesota United States 55455
    11 1 Site New Brighton Minnesota United States 55112
    12 1 Site Saint Joseph Missouri United States 64506
    13 1 Site Omaha Nebraska United States 68114
    14 1 Site Cleveland Ohio United States 44195
    15 1 Site Columbus Ohio United States 43215
    16 1 Site Nashville Tennessee United States 37215
    17 1 Site Pflugerville Texas United States 78660
    18 2 Sites San Antonio Texas United States 78218
    19 1 Site Webster Texas United States 77598

    Sponsors and Collaborators

    • ASLAN Pharmaceuticals

    Investigators

    • Study Director: Chief Medical Officer, ASLAN Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ASLAN Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05865041
    Other Study ID Numbers:
    • ASLAN003-004
    First Posted:
    May 18, 2023
    Last Update Posted:
    May 24, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ASLAN Pharmaceuticals
    farudodstat
    alopecia areata
    DHODH inhibitor
    ASLAN003
    Additional relevant MeSH terms:
    Alopecia
    Alopecia Areata

    Study Results

    No Results Posted as of May 24, 2023