A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorForte Biosciences, Inc.

About this trial

This is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of FB102 in patients with severe to very severe alopecia areata (AA).

Eligibility criteria

Qualifiers

Males aged 18-60 years and females aged 18-75 years at Screening.

Clinical diagnosis of severe to very severe AA with ≥50% scalp hair loss (including AT or AU) confirmed by SALT score and central photo review; no other cause of hair loss.

AT = complete scalp hair loss; AU = complete scalp, facial, and body hair loss. Note: There are additional inclusion criteria. The study center will determine if participant meets all of the criteria

Disqualifiers

Other types of alopecia (e.g., diffuse AA, traction, scarring alopecia, telogen effluvium, trichotillomania, chemotherapy-induced hair loss, androgenetic alopecia).

Other scalp diseases impacting AA assessment (e.g., psoriasis, dermatitis, tinea capitis).

Active systemic diseases causing hair loss (e.g., lupus, thyroiditis, systemic sclerosis, lichen planus, syphilis).

Trial design

Treatments tested in this trial

  • FB102
  • Placebo

Treatment groups

32 Participants
are divided into 2 treatment groups

Sponsors and collaborators