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A Phase 1/2 Study to Assess AMG 732 in Healthy Subjects and Subjects with Thyroid Eye Disease
EU CTIS ID: 2024-514110-12-00
What this study is testing
To investigate the efficacy of AMG 732 in subjects with TED after multiple subcutaneous doses
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject has provided informed consent before initiation of any study-specific activities/procedures.
- Male or female aged 18 to 55 years for Part A and male or female aged 18 to 65 years for Part B 65 years for Part B, inclusive, at the time of informed consent.
- Part B only: Moderate-to-severe active TED (not sight-threatening but has an appreciable impact on daily life), usually associated with 2 or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and inconstant or constant diplopia.
- Part B only: Subject had onset of active TED symptoms (as determined by subject records) within 15 months prior to baseline
- Part B only: Clinical diagnosis of Graves disease associated with active TED with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye at screening and baseline
- Part B only: Proptosis ≥ 18 mm in the study eye at baseline.
You likely can't join if
- Malignant condition in the past 12 months (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ)
- The subject has a major surgery within 8 weeks prior to the first dose of study drug or plans to have an elective surgery from screening through end of 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.
- History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined in this section) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.
- Part B only: Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, 9999) to the best of the subject and investigator’s knowledge, except when an eligible patient is contraindicated for 9999 in which case 9999 is not required. Also when subject did not consent for 9999 is not required.
- Subjects with a history of 9999, such as 9999.
See the full eligibility criteria
Who can join
- Subject has provided informed consent before initiation of any study-specific activities/procedures.
- Male or female aged 18 to 55 years for Part A and male or female aged 18 to 65 years for Part B 65 years for Part B, inclusive, at the time of informed consent.
- Part B only: Moderate-to-severe active TED (not sight-threatening but has an appreciable impact on daily life), usually associated with 2 or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and inconstant or constant diplopia.
- Part B only: Subject had onset of active TED symptoms (as determined by subject records) within 15 months prior to baseline
- Part B only: Clinical diagnosis of Graves disease associated with active TED with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye at screening and baseline
- Part B only: Proptosis ≥ 18 mm in the study eye at baseline.
- Part B Only: Subjects with baseline subjective binocular diplopia score > 0
- Part B Only: Subjects must be euthyroid with the baseline disease under control or have mild hypo or hyperthyroidism (defined as free thyroxine and free triiodothyronine levels < 50% below or above the normal limits) at screening. Every effort should be made to correct the mild hypo or hyperthyroidism promptly and to maintain the euthyroid state for the full duration of the trial.
- Part B Only: Does not require immediate surgical ophthalmological intervention and is not planning corrective surgery/irradiation during the trial
What rules you out
- Malignant condition in the past 12 months (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ)
- The subject has a major surgery within 8 weeks prior to the first dose of study drug or plans to have an elective surgery from screening through end of 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.
- History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined in this section) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety, or interfere with the study evaluation, procedures or completion.
- Part B only: Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, 9999) to the best of the subject and investigator’s knowledge, except when an eligible patient is contraindicated for 9999 in which case 9999 is not required. Also when subject did not consent for 9999 is not required.
- Subjects with a history of 9999, such as 9999.
- Laboratory Parameters for active liver disease, hepatic dysfunction or 9999 as determined by Part A: ALT or aspartate aminotransferase (AST) levels > 1.5 times upper limit of normal (ULN) Part B: ALT or AST levels > 3 times ULN or glomerular filtration rate ≤ 30 mL/min/1.73 m2 at screening. 9999
- Positive test for hepatitis B serology at screening defined as: (1) positive for hepatitis B surface antigen (HBsAg); OR (2) positive for hepatitis B core antibody (HBcAb). Patients HBsAg negative, hepatitis B surface antibody (HBsAb) positive and HBcAb negative due to vaccination are eligible for the study. Patients HBsAg negative and HBsAb positive for which the cause cannot be determined as vaccination will be considered ineligible for the study
- Positive test for human immunodeficiency virus (HIV) or hepatitis C virus (HCV) antibody at screening or within the last 12 months. Subjects successfully treated for an HCV infection are allowed to participate if a sustained virologic response was achieved, defined as aviremia 24 weeks after completion of the antiviral therapy.
- Subject tested positive for alcohol and/or drugs of abuse at screening
- Part A: History of substance abuse (eg, alcohol, nicotine or tobacco, and licit or illicit drugs) within 12 months before screening. Part B only: History of substance abuse (eg, alcohol and illicit drugs) within 12 months before screening.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Taiwan
- Canada
- United States
- Australia
- Japan
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Taiwan; Canada; United States; Australia; Japan. 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 EU CTIS; the study team decides eligibility.