A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy - Trial NCT06269393
Access comprehensive clinical trial information for NCT06269393 through Pure Global AI's free database. This Phase 3 trial is sponsored by Peking University People's Hospital and is currently Recruitment Completed. The study focuses on Thyroid Associated Ophthalmopathy. Target enrollment is 54 participants.
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Study Focus
Sponsor & Location
Peking University People's Hospital
Timeline & Enrollment
Phase 3
Jan 01, 2024
Feb 01, 2026
Primary Outcome
The proptosis responder rate (defined as percentage of subjects with a ≥ 2mm reduction from baseline in proptosis in the study eye, without deterioration [≥ 2 mm increase] of proptosis in the non-study eye) of the study eye.
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06269393
Non-Device Trial