Thyroid Eye Disease, TED Clinical Trial
Official title:
A Multicenter, Open-label Extension Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Thyroid Eye Disease
A multicenter, open-label extension study evaluating the efficacy and safety of IBI311 in subjects with thyroid eye disease
This is a multicenter, open-label outreach study. Participants who have previously participated in and completed CIBI311A201 double-blind treatment can enter this study after signing informed consent. The study included an observation period and an open treatment period. Observation period: From weeks D0 to 24, all subjects will return to the research center every 8 weeks for disease evaluation. If the investigator determines that treatment is required based on predefined criteria, they will enter the open treatment period to receive IBI311 treatment; Otherwise, subjects will continue to be visited every 8 weeks until week 24. Open Treatment period: Subjects entering the open treatment period will receive 8 infusions of IBI311 (initial dose of 10 mg/kg, followed by 7 maintenance doses of 20 mg/kg, Q3W. ;