Thyroid Eye DiseasePhase 4NCT07308964
Comparison of the Efficacy and Safety of 4 vs. 8 Treatments With Tepezza (Teprotumumab) for Thyroid Eye Disease
A Phase 4 study testing Teprotumumab Injection [Tepezza] in people with Thyroid Eye Disease and Thyroid Eye Disease, TED, run by Sheba Medical Center.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Eye Disease, Thyroid Eye Disease, TED, Thyroid Eye Disease (TED)
- What is being tested?
- Teprotumumab Injection [Tepezza]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to May 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
- Being tested
- Teprotumumab Injection [Tepezza]
- Keywords
- thyroid eye disease, TED, Tepezza, Teprotumumab
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Teprotumumab Injection [Tepezza] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response
Defined as a reduction of 2 or more points in the Clinical Activity Score (CAS), improvement in diplopia and exophthalmos.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Landau Prat Daphna, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308964
- Sponsor's protocol ID
- SMC-2514-25
- Status last verified
- Dec 2025
- First submitted
- 28 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No