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

Sheba Medical Center

Status and phase: Not yet enrolling; Phase 4

Conditions: Thyroid Eye Disease (TED); Thyroid Eye Disease, TED; Thyroid Eye Disease

Treatments: Drug: Teprotumumab Injection [Tepezza]

Study type: Interventional

Funder types: Other

Identifiers

NCT07308964

SMC-2514-25

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Participants in this arm will receive the full standard-of-care course of Teprotumumab. This consists of a total of 8 intravenous (IV) infusions.

Treatment:

Drug: Teprotumumab Injection [Tepezza]

Shortened Treatment

Experimental group

Description:

Participants in this arm will receive a shortened course of Teprotumumab. After demonstrating an "Early Optimal Clinical Response" following the first 4 infusions, treatment will be discontinued. These participants will receive a total of 4 intravenous (IV) infusions instead of the standard 8.

Treatment:

Drug: Teprotumumab Injection [Tepezza]