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

Description

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.

Conditions

Alopecia Areata

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Alopecia Areata
Intervention / Treatment

-

Contacts and Locations

Birmingham

1 Site, Birmingham, Alabama, United States, 35205

Fountain Valley

1 Site, Fountain Valley, California, United States, 92708

Santa Ana

1 Site, Santa Ana, California, United States, 92701

New Haven

1 Site, New Haven, Connecticut, United States, 06519

Washington

1 Site, Washington, District of Columbia, United States, 20037

Coral Gables

1 Site, Coral Gables, Florida, United States, 33134

Indianapolis

1 Site, Indianapolis, Indiana, United States, 46250

Louisville

1 Site, Louisville, Kentucky, United States, 40241

Brighton

1 Site, Brighton, Massachusetts, United States, 02135

Minneapolis

1 Site, Minneapolis, Minnesota, United States, 55455

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ASLAN Pharmaceuticals,

Chief Medical Officer, STUDY_DIRECTOR, ASLAN Pharmaceuticals

Study Record Dates

2024-10-31