Comparison of the Efficacy and Safety of 4 vs. 8 Treatments With Tepezza (Teprotumumab) for Thyroid Eye Disease
NCT ID: NCT07308964
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
40 participants
INTERVENTIONAL
2026-01-31
2028-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Standard 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.
Shortened 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Prof. Landau Prat Daphna
Oculoplastic and Orbital surgeon
Other Identifiers
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SMC-2514-25
Identifier Type: -
Identifier Source: org_study_id