An Open-label, Rollover Trial to Evaluate the Efficacy and Safety of AMG 732 in Participants With Thyroid Eye Disease
Key facts
- Where
- Kissimmee, Little Rock, Morgantown, and Orland Park, United StatesSee the 4 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT07438405, who can take part
Where in United States
- Ilumina Medical ResearchKissimmee, United StatesTaking people
- Applied Research Center of ArkansasLittle Rock, United StatesTaking people
- West Virginia UniversityMorgantown, United StatesTaking people
- Vision Medical Research Inc.Orland Park, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Amgen
- Trial code
- NCT07438405
- Record updated
- 23 July 2026
- Original description
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).Read full original descriptionShow less
An Open-label, Rollover Study for Participants With Thyroid Eye Disease Previously Enrolled in Amgen-sponsored AMG 732 Studies and Are Primary Proptosis Non-responders or Who Relapsed During the Safety Follow-up
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).
Inclusion: Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol; Age ≥ 18 years at the time of signing informed consent for parent trial; 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; Any worsening in thyroid status should be corrected to maintain euthyroid status for the entire rollover trial; Participants must use protocol-specified contraception during treatment and for an additional 6 months after the last dose of trial intervention; Participants with TED who completed Amgen-sponsored clinical trial of AMG 732.
Exclusion: Prior orbital irradiation or decompression in the study eye; Prior adult strabismus surgery; 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; Participants have had an adverse event that is considered related to AMG 732 which required study drug interruption/discontinuation in the parent study; 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; Use of any steroid or other non-steroid immunosuppressive agent, monoclonal antibody, within 3 months prior to the first injection of study drug; 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; Positive test for hepatitis B/C or Human immunodeficiency virus (HIV) serology at screening; Known hypersensitivity to teprotumumab, AMG 732 or any other monoclonal antibody products; History or existing inflammatory bowel disease (ulcerative colitis or Crohn's disease); Glycated hemoglobin (HbA1c) > 6.5% and/or fasting glucose levels> 126 mg/dL (> 7 mmol/L) at screening; Active liver or kidney disfunction at screening; Other protocol-defined inclusion/exclusion criteria apply.