Actively Recruiting
A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-Segmental Vitiligo
Led by Forte Biosciences, Inc. · Updated on 2025-11-20
64
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 efficacy of FB102, an intravenous drug, in patients with non-segmental vitiligo. This randomized, double-blind, placebo-controlled, multi-center Phase 1 study aims to better understand how FB102 may affect skin pigmentation in adults aged 18 to 75 years who have this condition. Approximately 64 participants will take part in the trial sponsored by Forte Biosciences, Inc. Participants will be randomly assigned to receive either FB102 or a matching placebo, both given through intravenous infusion. The treatment period lasts up to 16 weeks after the first dose administration. During this time, the study will closely monitor participants receiving these treatments to compare their effects on vitiligo. Participants will undergo regular assessments including facial and total vitiligo area scoring indexes to measure changes in skin pigmentation. Safety will also be evaluated by tracking treatment-emergent and serious adverse events. The study includes scheduled visits and evaluations up to 16 weeks post-treatment. This allows researchers to gather detailed information on the drug's impact and participant safety throughout the study period.
CONDITIONS
Brief Title
A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 to 75 years at time of Screening
- Confirmed diagnosis of non-segmental vitiligo at Screening and Baseline visits
- Stable medication regimen for conditions other than vitiligo for at least 7 days or 5 half-lives before Day 1
- Willingness to maintain stable medication regimen throughout the study
- Additional inclusion criteria determined by the study center
You will not qualify if you...
- Active forms of other hypopigmentation disorders (e.g., Vogt-Koyanagi-Harada disease, melanoma-induced hypopigmentation, post-inflammatory hypopigmentation, and others)
- Active inflammatory skin diseases or skin conditions interfering with vitiligo evaluation at Screening or Day 1
- More than approximately 33% depigmentation of hair (leukotrichia) in facial vitiligo areas
- Additional exclusion criteria determined by the study center
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.
Duration - Up to 16 weeks after first dose administration
Participants receive intravenous FB102 or placebo as part of the study treatment.
Trial Site Locations
Total: 6 locations
1
Skin & Cancer Foundation Australia - The Skin Hospital
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
2
Novatrials
Kotara, New South Wales, Australia, 2289
Actively Recruiting
3
Cornerstone Dermatology
Coorparoo, Queensland, Australia, 4151
Actively Recruiting
4
Optimal Clinical Trials North
Auckland, Auckland, New Zealand, 0632
Actively Recruiting
5
Optimal Clinical Trials Central
Auckland, Auckland, New Zealand, 1010
Actively Recruiting
6
Momentum Pukehoke
Auckland, Auckland, New Zealand, 2120
Actively Recruiting
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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