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Comparison of the Efficacy and Safety of 4 vs. 8 Treatments With Tepezza (Teprotumumab) for Thyroid Eye Disease
Sponsor: Sheba Medical Center
Summary
The goal of this interventional study is to compare the clinical outcomes of shortened 4-infusion course versus the standard 8-infusion course of Teprotumumab (Tepezza) in patients with active Thyroid Eye Disease (TED). The main question it aims to answer is: \* Is a shorter course equally effective and safe for patients who respond well early in treatment. Participants who demonstrate an early clinical response as part of their treatment with Teprotumumab will receive a shorter protocol of 4 infusions instead of the standard 8.
Official title: A Comparative Study of Shortened (4-Infusion) Versus Standard (8-Infusion) Teprotumumab Regimens in Patients With Thyroid Eye Disease (TED) Exhibiting an Early Optimal Clinical Response
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-01
Completion Date
2028-05
Last Updated
2025-12-30
Healthy Volunteers
No
Interventions
Teprotumumab Injection [Tepezza]
As a standard of care Teprotumumab is administered intravenously every 3 weeks for a total of 8 infusions (24 weeks). In the Shortened Arm participants receive a total of 4 infusions (12 weeks) provided they met the "Early Optimal Clinical Response" criteria at Week 12.