Pure Global
NCT06269393

A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy

An Exploratory Study of the Efficacy and Safety of IBI311, a Modified Anti-IGF-1R Antibody, in Patients With Steroid-resistant, Thyroid Associated Ophthalmopathy
Peking University People's Hospital·Phase 3·ClinicalTrials.gov·drugRecruitment Completed
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Thyroid Associated Ophthalmopathy
Drug/Device/Intervention
Placebo
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Peking University People's Hospital
Location
Beijing, China
Timeline & enrollment
Phase
Phase 3
Start date
Jan 01, 2024
End date
Feb 01, 2026
Enrollment
54 participants
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
ThyroiditisDisorders of thyroid glandThyroiditis, unspecifiedOther disorders of thyroidDisorder of thyroid, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06269393
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.