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Status:

RECRUITING

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

Lead Sponsor:

Forte Biosciences, Inc.

Conditions:

Alopecia Areata

Eligibility:

All Genders

18-75 years

Phase:

PHASE1

Brief 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).

Detailed Description

Up to approximately 32 participants who meet all the Screening eligibility criteria will be randomized in a 3:1 ratio to receive FB102, or placebo dosing to match.

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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).
  • Note: There are additional exclusion criteria. The study center will determine if participant meets all of the criteria

Key Trial Info

Start Date :

October 23 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 10 2027

Estimated Enrollment :

32 Patients enrolled

Trial Details

Trial ID

NCT07205159

Start Date

October 23 2025

End Date

March 10 2027

Last Update

November 20 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

St Leonards

Saint Leonards, New South Wales (nsw), Australia, 2065

2

Coorparoo

Coorparoo, Queensland, Australia, 4151

3

South Yarra

South Yarra, Victoria, Australia, 3141

4

Auckland

Auckland, Auckland, New Zealand, 0632