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

• Status: Recruiting
• Trial end date: 2024-04-18
• Target enrollment: 0
• Participant gender: All

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 50% or greater scalp hair loss.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ASLAN Pharmaceuticals

Criteria

Inclusion Criteria:

• Adult (≥18 years of age and a weight of ≥40 kg at the time of signing the informed consent)

• Has 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 50% scalp hair loss, as defined by a SALT score ≥50

3. Current episode of hair loss lasting at least 6 months and not exceeding 7 years at the time of Screening. Participants who have severe or very severe 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:

• Has known history of androgenic alopecia or female pattern hair loss prior to AA

• Has other types of alopecia (including, but not limited to traction and scarring alopecia, telogen effluvium, diffuse type of AA)

• Has history or presence of hair transplants

• Has other scalp disease that may impact AA assessment or require topical treatment (including, but not limited to scalp psoriasis, seborrheic dermatitis, actinic keratosis)