A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease

Summary

This is a multicenter, randomized, open-label, active-controlled Phase IV clinical trial in participants with active thyroid eye disease (TED). Approximately 92 eligible participants will be randomized to the teprotumumab N01 group and the intravenous glucocorticoid (IVGC) group in a 1:1 ratio on Day 1. The randomization stratification factor is diplopia at baseline (Gorman diplopia score ≥1 vs. Gorman diplopia score = 0).

Timeline

Start

2025-12-30

Primary completion

2026-09-12

Completion

2027-09-04

Publications

• Zhang H, Sun J, Li Y, Huang Y, Zhang S, Zhong S, Deng J, Zhu B, Lu S, Zhang W, Han-Zhang H, Jin Y, Qian L, Zhou H, Fan X. Head-to-Head Comparison of an IGF-1R Inhibitor Versus Intravenous Glucocorticoid for Active Thyroid Eye Disease: Design of a Randomized Clinical Trial. Ophthalmol Ther. 2026 Jul 14. doi: 10.1007/s40123-026-01451-9. Online ahead of print.

Drugs

Indications