Randomized Double-Blind Study of FB102 Versus Placebo to Evaluate Safety and Effectiveness in Adults With Non-Segmental Vitiligo

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 drugs impact and participant safety throughout the study period.

A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo