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

Last updated: December 12, 2023
Sponsor: ASLAN Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Alopecia

Hair Loss

Treatment

Farudodstat

Placebo

Clinical Study ID

NCT05865041
ASLAN003-004
  • Ages > 18
  • All Genders

Study 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 30% or greater scalp hair loss.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult (≥18 years of age and a weight of ≥40 kg at the time of signing the informedconsent)
  • Moderate, severe, or very severe Alopecia Areata (AA), as determined by meeting thefollowing criteria:
  1. Clinical diagnosis of AA with no other etiology of hair loss (e.g., telogeneffluvium, 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 yearsat the time of Screening. Participants who have AA for longer than 7 years may beenrolled if episodes of regrowth, spontaneous or under treatment, have beenobserved on the affected areas over the past 7 years
  4. No appreciable change (i.e., change exceeding 20 points on SALT score) interminal hair regrowth within 6 months

Exclusion

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, actinickeratosis)

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Farudodstat
Phase: 2
Study Start date:
April 14, 2023
Estimated Completion Date:
October 31, 2024

Connect with a study center

  • 1 Site

    Birmingham, Alabama 35205
    United States

    Active - Recruiting

  • 1 Site

    Fountain Valley, California 92708
    United States

    Active - Recruiting

  • 1 Site

    San Diego, California 92123
    United States

    Site Not Available

  • 1 Site

    Santa Ana, California 92701
    United States

    Active - Recruiting

  • 1 Site

    New Haven, Connecticut 06519
    United States

    Active - Recruiting

  • 1 Site

    Washington, District of Columbia 20037
    United States

    Active - Recruiting

  • 1 Site

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • 1 Site

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • 1 Site

    Louisville, Kentucky 40241
    United States

    Active - Recruiting

  • 1 Site

    Brighton, Massachusetts 02135
    United States

    Active - Recruiting

  • 1 Site

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • 1 Site

    New Brighton, Minnesota 55112
    United States

    Active - Recruiting

  • 1 Site

    Saint Joseph, Missouri 64506
    United States

    Active - Recruiting

  • 1 Site

    Omaha, Nebraska 68114
    United States

    Active - Recruiting

  • 1 Site

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • 1 Site

    Columbus, Ohio 43215
    United States

    Active - Recruiting

  • 1 Site

    Nashville, Tennessee 37215
    United States

    Active - Recruiting

  • 1 Site

    Pflugerville, Texas 78660
    United States

    Active - Recruiting

  • 2 Sites

    San Antonio, Texas 78218
    United States

    Active - Recruiting

  • 1 Site

    Webster, Texas 77598
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.