TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study
Status:
Not yet recruiting
Trial end date:
2025-08-01
Target enrollment:
Participant gender:
Summary
This is a double-masked, randomized, parallel-assignment, multicenter trial examining the
safety and tolerability of teprotumumab in the treatment of Thyroid Eye Disease (TED) in
adult participants. This international, Phase 3b/4 trial is being conducted to fulfill an FDA
post-marketing requirement for a descriptive trial to evaluate the safety, efficacy and need
for re-treatment of 3 different teprotumumab treatment durations for TED. In addition, serum
samples from participants with a Baseline Clinical Activity Score (CAS) ≥3 will be evaluated
for biomarkers of disease.