A Study of IBI311 in Subjects With Active Thyroid Eye Disease

Summary

This is a multicenter, randomized, double-masked, placebo-controlled Phase II/III study in subjects with active thyroid eye disease. Approximately 114 subjects meeting study eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 (D1) in a 2:1 ratio stratified by smoking status

Timeline

Start

2023-02-14

Primary completion

2023-12-20

Completion

2023-12-20

Publications

• Zhang H, Sun J, Li Y, Zhu L, Shan Z, Lu W, Shen J, Shi Y, Tao L, Jiang H, Ji L, Zhu Y, Gu H, Liu X, Sun B, Tian Y, Liu Q, Zhou J, Zhao H, Guan H, Zhu L, Wen J, Lu Y, Qiao J, Zhang W, Deng J, Lu S, Han-Zhang H, Qian L, Zhou H, Fan X. IGF-1R Inhibitor IBI311 for the Treatment of Active Thyroid Eye Disease in Chinese Patients: The RESTORE-1 Randomized Clinical Trial. JAMA Ophthalmol. 2025 Nov 1;143(11):964-971. doi: 10.1001/jamaophthalmol.2025.3350.

Drugs

Indications