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Second chance: new drug tested for stubborn thyroid eye disease

NCT ID NCT07438405

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tests a drug called AMG 732 in 30 adults with thyroid eye disease who either did not respond to treatment or saw their symptoms return after a previous study. The main goal is to see if the drug can reduce eye bulging by at least 2 millimeters without worsening the other eye. Participants will receive the drug as an injection under the skin.

What this could mean

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

Active substance
AMG 732 (a drug given as an injection under the skin)
What this could lead to
If successful, this could offer a treatment option for thyroid eye disease patients who did not improve or relapsed after initial therapy.
What could go wrong
This is a small, early-phase rollover study with only 30 participants, so results may not apply broadly. The drug may not work for all patients, and side effects are still being evaluated.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

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

Started

May 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 99 years

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 1. Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Age ≥ 18 years at the time of signing informed consent for parent trial. 3. Moderate-to-severe TED at the time of enrollment in parent trial and does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the rollover trial. 4. Any worsening in thyroid status should be corrected to maintain euthyroid status for the entire rollover trial. 5. Participants must use protocol-specified contraception during treatment and for an additional 6 months after the last dose of trial intervention. 6. Participants with TED who completed Amgen-sponsored clinical trial of AMG 732. Exclusion Criteria 1. Prior orbital irradiation or decompression in the study eye. 2. Prior adult strabismus surgery. 3. Use of any steroid (intravenous, oral, or injected) and steroid eye drops or other non-steroid immunosuppressive agent, monoclonal antibody except the trial drug in parent trial within a protocol-specified number of months prior to the first injection of study drug. 4. Glycated hemoglobin (HbA1c) \> 6.5% and/or fasting glucose levels\> 126 mg/dL (\> 7 mmol/L) at screening. 5. Malignant condition in the past 5 years or major surgery within 8 weeks or plans to have an elective surgery from screening through end of study. 6. Active liver or kidney disfunction at screening. 7. Positive test for hepatitis B/C or Human immunodeficiency virus (HIV) serology at screening. 8. Known hypersensitivity to teprotumumab, AMG 732 or any other monoclonal antibody products. 9. Participants have had an adverse event that is considered related to AMG 732 which required study drug interruption/discontinuation in the parent study 10. Donated blood, or had significant blood loss, or received a transfusion of any blood or blood products within 60 days prior to day 1 dosing or received a plasma donation within 7 days prior to day 1 dosing. 11. Use of any steroid or other non-steroid immunosuppressive agent, monoclonal antibody, within 3 months prior to the first injection of study drug. 12. History or existing inflammatory bowel disease (ulcerative colitis or Crohn's disease). 13. Other protocol-defined inclusion/exclusion criteria apply.

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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.

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Applied Research Center of Arkansas

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Eb Group Spolka z ograniczona odpowiedzialnoscia

    RECRUITING

    Warsaw, 00-189, Poland

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Virgen Macarena

    RECRUITING

    Seville, Andalusia, 41009, Spain

  • Ilumina Medical Research

    RECRUITING

    Kissimmee, Florida, 34744, United States

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • Vision Medical Research, Inc.

    RECRUITING

    Orland Park, Illinois, 60462, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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