NCT07205159

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Forte Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alopecia Areata

Interventions

Type	Name	Description
DRUG	FB102	Route of administration- Intravenous (IV)
DRUG	Placebo	Route of administration- Intravenous (IV)

Timeline

• Start date: 2025-10-23
• Primary completion: 2027-03-10
• Completion: 2027-03-10
• First posted: 2025-10-03
• Last updated: 2025-11-20

Locations

6 sites across 2 countries: Australia, New Zealand