NCT07113262

A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease

A Multicenter, Randomized, Double-masked, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 111 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A multicenter clinical study to evaluate the efficacy and safety of IBI311 in subjects with inactive thyroid eye disease. The study consists of two parts, with a maximum duration of approximately 64 weeks.

Detailed description

This study is a multicenter, randomized, double-masked, placebo-controlled Phase III clinical study in inactive TED subjects. Approximately 111 eligible subjects will be randomly assigned to the IBI311 group and the placebo group in a 2:1 ratio on Day 1. The study consists of two parts, with a maximum duration of approximately 64 weeks. Part 1 includes a screening period and a double-masked treatment period, lasting for a total of approximately 28 weeks. Part 2 is a follow-up/open treatment period, lasting for up to approximately 36 weeks.

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
DRUG	IBI311	Teprotumumab N01 injection (code name IBI311)
DRUG	Placebo	Placebo

Timeline

• Start date: 2025-09-10
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-08-08
• Last updated: 2025-11-17

Locations

1 site across 1 country: China