Clinical Trial

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

Recruiting Phase 4
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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).
Protocol Amendment History 3 changes
critical Recruitment opened 2026-08-14
notable Primary completion pushed: 2026-09-12 -> 2028-06-30 2026-08-14
minor Completion pushed: 2027-09-04 -> 2028-12-30 2026-08-14
Trial Details
NCT Number NCT07265258
Lead Sponsor Innovent Biologics (Suzhou) Co. Ltd.
Conditions Thyroid Eye Disease
Enrollment 92 participants
Start Date 2026-07-30
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-13