Recruiting
Phase 2

AMG 732

Sponsor:

Amgen

Code:

NCT07438405

Conditions

Thyroid Eye Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

AMG 732

Study Details

Brief 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).

Conditions

Thyroid Eye Disease

Study ID

NCT07438405

Start date

May 7, 2026

Status verified date

Jul, 2026

Completion date

Jul 14, 2028

Anticipated

Primary completion date

Jan 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AMG 732

Participants will receive AMG 732 subcutaneously (SC)

Interventions

AMG 732

AMG 732 will be administered SC.

Primary outcome measure

  • 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 [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Locations

Applied Research Center of Arkansas

Recruiting

Little Rock, Arkansas, United States, 72205

Ilumina Medical Research

Recruiting

Kissimmee, Florida, United States, 34744

Vision Medical Research, Inc.

Recruiting

Orland Park, Illinois, United States, 60462

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

More Information

Sponsor

Amgen

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Thyroid eye disease
  • AMG 732

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amgen on 2026-07-23.