Recruiting

Phase 2

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

Sponsor:

ASLAN Pharmaceuticals

Code:

NCT05865041

Conditions

Alopecia Areata

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Farudodstat

Placebo

Study Details

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 30% or greater scalp hair loss.

Conditions

Alopecia Areata

Study ID

NCT05865041

Start date

Apr 14, 2023

Status verified date

Dec, 2023

Completion date

Oct 31, 2024

Anticipated

Primary completion date

Sep 12, 2024

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

Farudodstat

Farudodstat tablets administered orally

Placebo

Placebo tablets administered orally

Primary outcome measure

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

Central Contacts and Locations

Central contacts

ASLAN Pharmaceuticals

+65 6817 9598 contact@aslanpharma.com

Locations

1 Site

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

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

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information