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Clinical Trial NCT07308964 for Thyroid Eye Disease, Thyroid Eye Disease, TED, Thyroid Eye Disease (TED) is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Comparison of the Efficacy and Safety of 4 vs. 8 Treatments With Tepezza (Teprotumumab) for Thyroid Eye Disease Phase 4 40

Not yet recruiting
Clinical Trial NCT07308964 is designed to study Treatment for Thyroid Eye Disease, Thyroid Eye Disease, TED, Thyroid Eye Disease (TED). This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on January 1, 2026 until the study accrues 40 participants. Led by Sheba Medical Center, this study is expected to complete by May 1, 2028. The latest data from ClinicalTrials.gov was last updated on December 30, 2025.
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 a...

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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

Conditions
Thyroid Eye DiseaseThyroid Eye Disease, TEDThyroid Eye Disease (TED)
Other Study IDs
  • SMC-2514-25
NCT ID Number
NCT07308964
Start Date (Actual)
2026-01
Last Update Posted
2025-12-30
Completion Date (Estimated)
2028-05
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
thyroid eye disease
TED
Tepezza
Teprotumumab
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorStandard of Care
Participants in this arm will receive the full standard-of-care course of Teprotumumab. This consists of a total of 8 intravenous (IV) infusions.
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.
ExperimentalShortened Treatment
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.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Clinical Response
Defined as a reduction of 2 or more points in the Clinical Activity Score (CAS), improvement in diplopia and exophthalmos.
1 year
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • 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.
Sheba Medical Center logoSheba Medical Center
Study Responsible Party
Prof. Landau Prat Daphna, Principal Investigator, Oculoplastic and Orbital surgeon, Sheba Medical Center
No contact data.