Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata
Led by Forte Biosciences, Inc. · Updated on 2025-11-20
32
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of FB102 in adults with severe to very severe alopecia areata, a condition causing significant hair loss. This randomized, double-blind, placebo-controlled Phase 1 study aims to better understand how FB102 works compared to a placebo in this patient group. Up to 32 participants will be randomly assigned in a 3 to 1 ratio to receive either FB102 or a matching placebo. Both treatments are given intravenously. The study will monitor participants over several weeks, assessing safety and changes in hair loss severity. Participants will be involved in the study for up to 36 weeks after their first dose. During this time, they will undergo regular evaluations including tracking treatment-related side effects and measuring changes in hair loss using the Severity of Alopecia Tool (SALT) score. Researchers will carefully monitor safety and treatment responses throughout the study.
CONDITIONS
Brief Title
A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males aged 18 to 60 years and females aged 18 to 75 years at Screening
- Clinical diagnosis of severe to very severe alopecia areata with 50% or more scalp hair loss confirmed by Severity of Alopecia Tool (SALT) score and central photo review
- No other cause of hair loss
- The study center will determine if participant meets all additional inclusion criteria
You will not qualify if you...
- Other types of alopecia such as diffuse AA, traction, scarring alopecia, telogen effluvium, trichotillomania, chemotherapy-induced hair loss, or androgenetic alopecia
- Other scalp diseases affecting alopecia areata assessment such as psoriasis, dermatitis, or tinea capitis
- Active systemic diseases causing hair loss including lupus, thyroiditis, systemic sclerosis, lichen planus, or syphilis
- The study center will determine if participant meets all additional exclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks
Participants receive intravenous FB102 or matching placebo as part of the study treatment.
Visits occur during dosing and assessments up to Week 16
Duration - Up to 20 weeks post treatment
Participants are monitored for safety, including treatment-emergent and serious adverse events, up to 36 weeks after the first dose.
Visits for safety monitoring up to Week 36
Trial Site Locations
Total: 6 locations
1
St Leonards
Saint Leonards, New South Wales (nsw), Australia, 2065
Not Yet Recruiting
2
Coorparoo
Coorparoo, Queensland, Australia, 4151
Actively Recruiting
3
South Yarra
South Yarra, Victoria, Australia, 3141
Not Yet Recruiting
4
Auckland
Auckland, Auckland, New Zealand, 0632
Not Yet Recruiting
5
Christchurch
Christchurch, Canterbury, New Zealand, 8013
Not Yet Recruiting
6
Palmerston North
Palmerston North, Palmerston North Central, New Zealand, 4414
Not Yet Recruiting
Research Team
S
Support Officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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