NCT06126783

A Multicenter, Open-label Extension Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Thyroid Eye Disease

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, open-label extension study evaluating the efficacy and safety of IBI311 in subjects with thyroid eye disease

Detailed description

This is a multicenter, open-label outreach study. Participants who have previously participated in and completed CIBI311A201 double-blind treatment can enter this study after signing informed consent. The study included an observation period and an open treatment period. Observation period: From weeks D0 to 24, all subjects will return to the research center every 8 weeks for disease evaluation. If the investigator determines that treatment is required based on predefined criteria, they will enter the open treatment period to receive IBI311 treatment; Otherwise, subjects will continue to be visited every 8 weeks until week 24. Open Treatment period: Subjects entering the open treatment period will receive 8 infusions of IBI311 (initial dose of 10 mg/kg, followed by 7 maintenance doses of 20 mg/kg, Q3W.

Conditions

• Thyroid Eye Disease, TED

Interventions

Type	Name	Description
DRUG	IBI311	The first dose was 10 mg/kg, followed by 7 maintenance doses of 20 mg/kg, Q3W

Timeline

• Start date: 2023-10-20
• Primary completion: 2026-05-30
• Completion: 2026-12-31
• First posted: 2023-11-13
• Last updated: 2024-12-13

Locations

1 site across 1 country: China