NCT07438405 · Amgen
An Open-label, Rollover Trial to Evaluate the Efficacy and Safety of AMG 732 in Participants With Thyroid Eye Disease
(HAZEL 401)
What this study is about
The main objective of this trial is to assess the effectiveness 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).
View original scientific 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
- Glycated hemoglobin (HbA1c) \> 6.5% and/or fasting glucose levels\> 126 mg/dL (\> 7 mmol/L) at screening.
- 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.
- Active liver or kidney disfunction at screening.
- 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.
- 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.
- History or existing inflammatory bowel disease (ulcerative colitis or Crohn's disease).
- Other protocol-defined inclusion/exclusion criteria apply.
Where
- Little Rock, Arkansas
- Kissimmee, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations