A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy
Status:
ACTIVE_NOT_RECRUITING
Trial end date:
2026-02-01
Target enrollment:
Participant gender:
Summary
This is an exploratory study of the efficacy and safety of IBI311, a modified anti-IGF-1R antibody, in patients with steroid-resistant, thyroid associated ophthalmopathy (TAO). This study includes two stages. Stage I is a single-center, single-arm, open-label clinical study designed to evaluate the safety and tolerability of IBI311 in subjects with TAO. Approximately 10 subjects meeting the study eligibility criteria will be enrolled. Stage II is a single-center, randomized, double-masked, placebo-controlled clinical trial designed to evaluate the efficacy and safety of IBI311 in subjects with steroid-resistant TAO. Approximately 54 subjects meeting the study eligibility criteria will be randomly assigned to IBI311 or placebo on day 1 (D1) in a 2:1 ratio stratified by disease activity.