NCT05795621

A Study of IBI311 in Subjects With Active Thyroid Eye Disease

A Multicenter, Randomized, Double-masked, Placebo-controlled Phase II/III Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Active Thyroid Eye Disease

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
BIOLOGICAL	IBI311	10 mg/kg on Day 1 followed by 20 mg/kg q3W for the remaining 7 infusions for phase II/III.
BIOLOGICAL	placebo	4 does of placebo for phase II; 8 does of placebo for phase III.

Timeline

• Start date: 2023-02-14
• Primary completion: 2023-12-20
• Completion: 2023-12-20
• First posted: 2023-04-03
• Last updated: 2024-02-08

Locations

1 site across 1 country: China