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New treatment option for Thyroid Eye Disease
Official title A Study of AMG 732 in Healthy Participants and Participants With Thyroid Eye Disease
ClinicalTrials.gov ID: NCT06401044
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 primary objective of Part A of this study is to investigate the safety and tolerability of AMG 732 after single subcutaneous (SC) doses. The primary objective of Part B of this study is to investigate the efficacy of AMG 732 in participants with Thyroid Eye Disease (TED) after multiple SC doses.
- 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 65. Healthy volunteers may be eligible.
You may be able to join if
- for Part A/Phase 1 only:
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Male or female aged 18 to 55 years (Part A).
- Female participants must be of non-childbearing potential.
- Body mass index (BMI) between 18 and 30 kg/m\^2, inclusive, at screening.
You likely can't join if
- for Part A and Part B:
- Malignant condition in the past 12 months 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.
- Glycated hemoglobin (HbA1c) \> 6.5% and/or fasting glucose levels\> 126 mg/dL (\> 7 mmol/L) at screening.
- Use of any steroid (IV, oral, steroid eye drops) within 3 weeks prior to the first dose. Steroids cannot be initiated during the trial. Exceptions...
See the full eligibility criteria
- for Part A/Phase 1 only:
- Participant has provided informed consent before initiation of any study-specific activities/procedures.
- Male or female aged 18 to 55 years (Part A).
- Female participants must be of non-childbearing potential.
- Body mass index (BMI) between 18 and 30 kg/m\^2, inclusive, at screening.
- The participant has adequate venous access and can receive intravenous (IV) therapy.
- The participant is considered by the investigator or designee to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG)...
- Healthy Japanese participants in cohort 4 only. Japanese participants must meet all the following as confirmed by interview: Descendants of 4 ethnic Japanese grandparents who were born in Japan; Both parents are ethnic...
- Male or female aged 18 to 65 years.
- Moderate-to-severe active TED.
- The participant had onset of active TED within 15 months prior to baseline.
- Clinical diagnosis of Graves' disease associated with active TED with a Clinical Activity Score (CAS)≥3 for the most severely affected eye at screening and baseline.
- Proptosis ≥18mm in the study eye at baseline.
- Participants with baseline subjective binocular diplopia score \>0.
- Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the trial.
- for Part A and Part B:
- Malignant condition in the past 12 months 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.
- Glycated hemoglobin (HbA1c) \> 6.5% and/or fasting glucose levels\> 126 mg/dL (\> 7 mmol/L) at screening.
- Use of any steroid (IV, oral, steroid eye drops) within 3 weeks prior to the first dose. Steroids cannot be initiated during the trial. Exceptions include topical and inhaled steroids and steroids used to treat...
- Known hypersensitivity to teprotumumab or any other monoclonal antibody products.
- History of substance abuse within 12 months before screening.
- 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. Exclusion...
- Blood pressure or ECG abnormalities at screening. Exclusion criteria for Part B/Phase 2 only:
- Use of any steroid or other non-steroid immunosuppressive agent, monoclonal antibody, within 3 months prior to the first injection of study drug.
- Use of teprotumumab or any other IGF-1R inhibitor.
- Prior orbital irradiation or decompression in the study eye.
- 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
- Newport Beach, California, United States
- Jacksonville, Florida, United States
- Kissimmee, Florida, United States
- Sarasota, Florida, United States
- Orland Park, Illinois, United States
- Boston, Massachusetts, United States
- Las Vegas, Nevada, United States
- Erie, Pennsylvania, United States
- Houston, Texas, United States
- Shavano Park, Texas, United States
- Morgantown, West Virginia, United States
- North Ryde, New South Wales, Australia
- St Leonards, New South Wales, Australia
- Vancouver, British Columbia, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Nantes, France
- Paris, France
- Essen, Germany
+ 21 more site(s).
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 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Newport Beach, California, United States; Jacksonville, Florida, United States; Kissimmee, Florida, United States; Sarasota, Florida, United States; Orland Park, Illinois, United States and 35 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.