RECRUITING

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

Conditions

Alopecia Areata farudodstat DHODH inhibitor ASLAN003

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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 30% or Greater Scalp Hair Loss

Quick Facts

Study Start:2023-04-14

Study Completion:2024-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05865041

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)

Inclusion Criteria

Exclusion 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)

Contacts and Locations

Study Contact

ASLAN Pharmaceuticals

CONTACT

+65 6817 9598

contact@aslanpharma.com

Principal Investigator

Chief Medical Officer

STUDY_DIRECTOR

ASLAN Pharmaceuticals

Study Locations (Sites)

1 Site

Birmingham, Alabama, 35205

United States

1 Site

Fountain Valley, California, 92708

United States

1 Site

Santa Ana, California, 92701

United States

1 Site

New Haven, Connecticut, 06519

United States

1 Site

Washington, District of Columbia, 20037

United States

1 Site

Coral Gables, Florida, 33134

United States

1 Site

Indianapolis, Indiana, 46250

United States

1 Site

Louisville, Kentucky, 40241

United States

1 Site

Brighton, Massachusetts, 02135

United States

1 Site

Minneapolis, Minnesota, 55455

United States

1 Site

New Brighton, Minnesota, 55112

United States

1 Site

Saint Joseph, Missouri, 64506

United States

1 Site

Omaha, Nebraska, 68114

United States

1 Site

Cleveland, Ohio, 44195

United States

1 Site

Columbus, Ohio, 43215

United States

1 Site

Nashville, Tennessee, 37215

United States

1 Site

Pflugerville, Texas, 78660

United States

2 Sites

San Antonio, Texas, 78218

United States

1 Site

Webster, Texas, 77598

United States

Collaborators and Investigators

Sponsor: ASLAN Pharmaceuticals

Chief Medical Officer, STUDY_DIRECTOR, ASLAN Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-14

Study Completion Date2024-10-31

Study Record Updates

Study Start Date2023-04-14

Study Completion Date2024-10-31

Terms related to this study

Keywords Provided by Researchers

farudodstat
alopecia areata
DHODH inhibitor
ASLAN003

Additional Relevant MeSH Terms

Alopecia Areata