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

ConditionsThyroid Eye Disease Thyroid Eye Disease, TED Thyroid Eye Disease (TED)

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorSheba Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Sequential

Treatments tested in this trial

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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Standard of CareActive comparator 1 intervention

Group B: Shortened TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Clinical Response

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

Time frame

1 year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sheba Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: