RecruitingPhase 1NCT07205159

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

A Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.

Sponsor

Forte Biosciences, Inc.

Enrollment

32 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

Alopecia Areata

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria2

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.

Exclusion Criteria3

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).

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