clinical trial · NCT07265258
A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease
Innovent Biologics (Suzhou) Co. Ltd.·phase4·not yet recruiting·n = 92
Thyroid Eye DiseaseTeprotumumab N01Methylprednisolone
brief 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).
started
Dec 30, 2025
primary completion
Sep 12, 2026
completion
Sep 4, 2027
last updated
Dec 4, 2025
official title
A Multicenter, Randomized, Open-Label, Active-Controlled Phase IV Clinical Study to Evaluate the Efficacy and Safety of Teprotumumab N01 in the Treatment of Active Thyroid Eye Disease
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol