Investigate the Efficacy and Safety of Farudodstat Compared With Its Placebo in Adult Alopecia Areata Participants (FAST-AA)

Aslan Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Alopecia Areata

Treatments: Drug: Farudodstat; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05865041

ASLAN003-004

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Farudodstat for 12 weeks followed by placebo for 12 weeks

Experimental group

Description:

Farudodstat 100mg twice daily for 12 weeks followed by matching Placebo twice daily for 12 weeks

Treatment:

Drug: Placebo

Drug: Farudodstat

Placebo for 12 weeks followed by farudodstat for 12 weeks

Experimental group

Description:

Matching Placebo twice daily for 12 weeks followed by farudodstat 100mg twice daily for 12 weeks

Treatment:

Drug: Placebo

Drug: Farudodstat