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Second chance: new drug tested for stubborn thyroid eye disease
NCT ID NCT07438405
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
8 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Applied Research Center of Arkansas
RECRUITINGLittle Rock, Arkansas, 72205, United States
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Eb Group Spolka z ograniczona odpowiedzialnoscia
RECRUITINGWarsaw, 00-189, Poland
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Hospital Universitari i Politecnic La Fe
RECRUITINGValencia, 46026, Spain
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Hospital Universitario Virgen Macarena
RECRUITINGSeville, Andalusia, 41009, Spain
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Ilumina Medical Research
RECRUITINGKissimmee, Florida, 34744, United States
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National Taiwan University Hospital
RECRUITINGTaipei, 10002, Taiwan
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Vision Medical Research, Inc.
RECRUITINGOrland Park, Illinois, 60462, United States
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West Virginia University
RECRUITINGMorgantown, West Virginia, 26506, United States
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- Can an experimental drug reduce eye bulging in thyroid eye disease?
- Can a new drug ease bulging eyes in thyroid disease?
- New drug IBI3031 enters first human trial for thyroid eye disease