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

ASLAN Pharmaceuticals60 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Alopecia Areata

Interventions

FarudodstatDRUG

Farudodstat tablets administered orally

PlaceboDRUG

Placebo tablets administered orally

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion 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 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, actinic keratosis)

Locations (19)

1 Site

Birmingham, Alabama, United States

RECRUITING

1 Site

Fountain Valley, California, United States

Outcomes

Primary Outcomes

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

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).

Time frame: Treatment Start to Week 12

Incidence of adverse events (AEs) up to Week 28

Time frame: Treatment Start to Week 28

Number of participants with clinically significant laboratory parameters

Time frame: Treatment Start to Week 28

Number of participants with clinically significant Electrocardiogram (ECG) parameters

Time frame: Treatment Start to Week 28

Secondary Outcomes

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

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).

Time frame: Treatment Start to Week 12

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

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).

Time frame: Treatment Start to Week 12

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

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).

Central Contacts

ASLAN Pharmaceuticals

CONTACT

+65 6817 9598 contact@aslanpharma.com

Data from ClinicalTrials.gov

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1 Site

Santa Ana, California, United States

RECRUITING

1 Site

New Haven, Connecticut, United States

RECRUITING

1 Site

Washington D.C., District of Columbia, United States

RECRUITING

1 Site

Coral Gables, Florida, United States

RECRUITING

1 Site

Indianapolis, Indiana, United States

RECRUITING

1 Site

Louisville, Kentucky, United States

RECRUITING

1 Site

Brighton, Massachusetts, United States

RECRUITING

1 Site

Minneapolis, Minnesota, United States

RECRUITING

...and 9 more locations

Time frame: Treatment Start to Week 12

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

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).

Time frame: Treatment Start to Week 12

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

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).

Time frame: Treatment Start to Week 12

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

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).

Time frame: Treatment Start to Week 12

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.

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

Time frame: Treatment Start to Week 12

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.

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

Time frame: Treatment Start to Week 12

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.

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

Time frame: Treatment Start to Week 12

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.

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.

Time frame: Treatment Start to Week 12

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.

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.

Time frame: Treatment Start to Week 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)

Time frame: Treatment Start to Week 12