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

Not Applicable

Not yet recruiting

• Conditions: Alopecia Areata
• Interventions: Drug: FB102; Drug: Placebo

• Registration Number: NCT07205159
• Lead Sponsor: Forte Biosciences, Inc.

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-25
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Study Start: 2025-10-15
• Primary Completion: 2026-08-03
• Study Completion: 2026-12-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

2. 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 Criteria

1. Other types of alopecia (e.g., diffuse AA, traction, scarring alopecia, telogen effluvium, trichotillomania, chemotherapy-induced hair loss, androgenetic alopecia).
2. Other scalp diseases impacting AA assessment (e.g., psoriasis, dermatitis, tinea capitis).
3. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FB102	FB102	Participants will receive FB102.
Placebo	Placebo	Matching placebo

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	Upto 36 Weeks post first dose administration
Change from Baseline of Severity of Alopecia Tool (SALT) score at Week 16.	From Screening through Week 16.

Trial Locations

Locations (6)

St Leonards; 🇦🇺 Saint Leonards, New South Wales (nsw), Australia

Coorparoo; 🇦🇺 Coorparoo, Queensland, Australia

South Yarra; 🇦🇺 South Yarra, Victoria, Australia

Auckland; 🇳🇿 Auckland, Auckland, New Zealand

Christchurch; 🇳🇿 Christchurch, Canterbury, New Zealand

Palmerston North; 🇳🇿 Palmerston North, Palmerston North Central, New Zealand