Comparison of the Efficacy and Safety of 4 vs. 8 Treatments With Tepezza (Teprotumumab) for Thyroid Eye Disease

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.

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Key information

Conditions

Thyroid Eye Disease Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Goiter Graves Disease Graves Ophthalmopathy Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases Thyroid Eye Disease (TED) Thyroid Eye Disease, TED

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants must have a confirmed diagnosis of active Thyroid Eye Disease (TED).
Participants must be eligible for and have started the standard Teprotumumab (Tepezza) treatment protocol.
Participants must demonstrate a significant clinical response by the 4th infusion.
Ability to understand and provide signed written informed consent.

Exclusion criteria

Previous use of Teprotumumab or other biologic therapies for TED.
Participants who do not show early clinical response after the 4th infusion.
Participants who have any medical contraindications to Teprotumumab or any of its components.
Participants who have any known hearing problems.

Treatment and study plan

Teprotumumab Injection [Tepezza]

Drug

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.

Primary outcomes

Clinical Response

Time frame: 1 year

Defined as a reduction of 2 or more points in the Clinical Activity Score (CAS), improvement in diplopia and exophthalmos.

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Dec 30, 2025
Registry last updated: Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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