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Could fewer infusions tame thyroid eye disease?

NCT ID NCT07308964

Disease control Sponsor: Sheba Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a shortened 4-infusion course of the drug Teprotumumab (Tepezza) against the standard 8-infusion course for people with active thyroid eye disease. Only patients who show a good early response will be eligible for the shorter regimen. The goal is to see if fewer infusions can be just as effective and safe, potentially saving time and reducing side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Teprotumumab (Tepezza)
What this could lead to
If successful, this could mean fewer infusions for patients who respond quickly, reducing treatment burden and side effects while maintaining effectiveness.
What could go wrong
This is a small Phase 4 study with only 40 participants, so results may not apply to all patients. The shorter course might not control the disease as well long-term, and risks like hearing problems or muscle spasms from teprotumumab remain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

endocrine exophthalmos Graves Ophthalmopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thyroid eye disease Thyroid eye disease, ted

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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Other studies related to the condition(s) this trial covers.