A Study of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease

Summary

This is a multicenter, randomized, double-masked phase II study evaluating the efficacy and safety of IBI311 in subjects with inactive or active thyroid eye disease. Approximately 36 subjects meeting the study eligibility criteria will be randomly assigned to the 3-10 mg group, 3-20 mg group, 10 mg group, or 20 mg group on day 1 in a 1:1:2:2 ratio. Dose conversion of the 3-10 mg or 3-20 mg group was performed at week 12. Active and inactive TED was a stratification factor in this study. Active and inactive TED subjects were enrolled in a 1:1 ratio.

Timeline

Start

2024-09-04

Primary completion

2025-01-09

Completion

2025-09-22

Drugs

Indications