Not Yet RecruitingPhase 4

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

40 participantsStarted 2026-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Clinical Response

Timeframe: 1 year

Trial details

NCT IDNCT07308964

SponsorSheba Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2028-01

View on ClinicalTrials.gov More Thyroid Eye Disease trials