NCT06525506

A Study of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease

A Multicenter, Randomized, Double-Masked Phase II Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (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 phase II study evaluating the efficacy and safety of IBI311 in subjects with inactive or active thyroid eye disease. Approximately 36 subjects meeting the study eligibility criteria will be randomly assigned to the 3-10 mg group, 3-20 mg group, 10 mg group, or 20 mg group on day 1 in a 1:1:2:2 ratio. Dose conversion of the 3-10 mg or 3-20 mg group was performed at week 12. Active and inactive TED was a stratification factor in this study. Active and inactive TED subjects were enrolled in a 1:1 ratio.

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
BIOLOGICAL	IBI311 (20 mg)	Arm 4: 10 mg/kg IBI311 on Day 1, followed by 20 mg/kg IBI311 from week 3 to week 21, Q3W.
BIOLOGICAL	IBI311 (3-20 mg)	Arm 2: 3 mg/kg IBI311 from day 1 to week 9, Q3W, followed by 20 mg/kg IBI311 from week 12 to week 21, Q3W.
BIOLOGICAL	IBI311 (10 mg)	Arm 3: 10 mg/kg IBI311 from day 1 to week 21, Q3W.
BIOLOGICAL	IBI311 (3-10mg/kg)	Arm 1: 3 mg/kg IBI311 from day 1 to week 9, Q3W, followed by 10 mg/kg IBI311 from week 12 to week 21, Q3W.

Timeline

• Start date: 2024-09-04
• Primary completion: 2025-01-09
• Completion: 2025-09-22
• First posted: 2024-07-29
• Last updated: 2025-10-03

Locations

1 site across 1 country: China