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Recruiting Phase 2

An Open-label, Rollover Trial to Evaluate the Efficacy and Safety of AMG 732 in Participants With Thyroid Eye Disease

NCT07438405 · tracked via the Priya Life Science Spain tracker
Sponsor
Phase
Phase 2
Started
2026-05-07
Last updated
2026-07-23

Condition(s) studied

Thyroid Eye Disease

Investigational drug(s) / intervention(s)

AMG 732 →

AMG 732: AMG 732 will be administered SC.

Study summary

The main objective of this trial is to assess the efficacy of AMG 732 in participants with thyroid eye disease (TED) who are defined as primary nonresponders or relapsed during the safety follow-up in the parent trial (NCT06401044).

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who are Defined as Primary Nonresponders or Relapsed During the Safety Follow-up in the Parent Trial — Week 24
    Responders are defined as participants with a ≥ 2 mm reduction from baseline in the trial eye without deterioration (≥ 2 mm increase) of proptosis in the fellow eye.

Trial sites (8)

FacilityCityRegionStatus
Applied Research Center of Arkansas Little Rock Arkansas Recruiting
Ilumina Medical Research Kissimmee Florida Recruiting
Vision Medical Research, Inc. Orland Park Illinois Recruiting
West Virginia University Morgantown West Virginia Recruiting
Eb Group Spolka z ograniczona odpowiedzialnoscia Warsaw Poland Recruiting
Hospital Universitario Virgen Macarena Seville Andalusia Recruiting
Hospital Universitari i Politecnic La Fe Valencia Spain Recruiting
National Taiwan University Hospital Taipei Taiwan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07438405 on ClinicalTrials.gov ↗ ← All trials in Spain