Overview

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

Status:
NOT_YET_RECRUITING
Trial end date:
2027-09-04
Target enrollment:
Participant gender:
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).
Phase:
PHASE4
Details
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Treatments:
Methylprednisolone