A Multicenter, Randomized, Double-masked, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease
A multicenter clinical study to evaluate the efficacy and safety of IBI311 in subjects with inactive thyroid eye disease. The study consists of two parts, with a maximum duration of approximately 64 weeks.
• At screening and baseline, the following diagnostic criteria for inactive TED were met:
⁃ CAS of both eyes ≤ 2 points during the screening period and baseline;
⁃ According to the subject's medical history, CAS of both eyes ≤ 2 points at least 6 months before screening, or according to the subject's chief complaint or medical history, with all of the following characteristics: no progression of proptosis and no new diplopia caused by TED at least 6 months before screening or no progression of diplopia caused by TED and no new inflammatory TED symptoms;
⁃ According to the subject's chief complaint or medical history, the first TED diagnosis before screening was ≥ 2 years and \< 10 years.
• At baseline, the proptosis of the study eye was ≥20 mm. 3.If the subject is a female, she should be infertile or have a negative blood pregnancy test during the screening period and agree to take contraceptive measures from the screening period to 120 days after the last medication. If the subject is a male, he should agree to take contraceptive measures from the screening period to 120 days after the last medication.