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Tests treatment safety and results for Thyroid Eye Disease
Official title An Open-label, Rollover Trial to Evaluate the Efficacy and Safety of AMG 732 in Participants With Thyroid Eye Disease
ClinicalTrials.gov ID: NCT07438405
What this study is testing
What is AMG 732?
AMG 732 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for thyroid eye disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this...
- 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...
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Kissimmee, Florida, United States
- Orland Park, Illinois, United States
- Morgantown, West Virginia, United States
- Warsaw, Poland
- Seville, Andalusia, Spain
- Valencia, Spain
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Kissimmee, Florida, United States; Orland Park, Illinois, United States; Morgantown, West Virginia, United States; Warsaw, Poland; Seville, Andalusia, Spain and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.