Phase II Study Evaluating Subcutaneous GenSci048 Versus Placebo in Adults With Active Non-infectious Uveitis

What this Trial Is About

Researchers are evaluating the efficacy and safety of GenSci048 compared with a placebo in adults with active non-infectious uveitis. This phase II study focuses on patients who have intermediate, posterior, or pan-uveitis and have had the condition for over a year. The study aims to understand how well GenSci048 works when given by subcutaneous injection and to monitor any potential side effects. Participants receive either a high dose of GenSci048 or a placebo by subcutaneous injection every four weeks according to the study protocol. The study is randomized and participants are assigned to one of the two groups. The treatment period lasts up to 25 weeks, with ongoing assessments of the drugs pharmacokinetics and immunogenicity continuing for up to 197 days. During the study, participants will have regular visits for dosing and assessments that include monitoring for treatment effectiveness and safety. Researchers will evaluate the response to treatment, track any adverse events, and collect data on the bodys handling of the drug. The total follow-up may last up to 29 weeks, allowing comprehensive observation of treatment impact and safety over time.

A Study of Efficacy and Safety of GenSci048 in Subjects With Active Uveitis.