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

NCT07308964 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: SMC-2514-25
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thyroid Eye Disease (TED); Thyroid Eye Disease

Keywords

thyroid eye disease; TED; Tepezza; Teprotumumab

Outcome Measures

Primary Outcomes (1)

• Clinical Response

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

  1 year

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Drug: Teprotumumab Injection [Tepezza]

Shortened Treatment

EXPERIMENTAL

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.

Drug: Teprotumumab Injection [Tepezza]

Interventions

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.

Shortened Treatment; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

teprotumumab

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oculoplastic and Orbital surgeon

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: December 30, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: December 30, 2025

Record last verified: 2025-12