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

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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07308964

Enrollment

Registered

2025-12-30

Start date

2026-01-31

Completion date

2028-05-31

Last updated

2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Eye Disease, Thyroid Eye Disease (TED), Thyroid Eye Disease, TED

Keywords

thyroid eye disease, TED, Tepezza, Teprotumumab

Brief 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.

Interventions

DRUGTeprotumumab 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.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Clinical Response	1 year	Defined as a reduction of 2 or more points in the Clinical Activity Score (CAS), improvement in diplopia and exophthalmos.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026