An Open-label, Rollover Trial to Evaluate the Efficacy and Safety of AMG 732 in Participants With Thyroid Eye Disease

Ki vehet részt

• 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

Ki nem vehet részt

• 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
• 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
• 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
• 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
• History or existing inflammatory bowel disease (ulcerative colitis or Crohn's disease)
• Glycated hemoglobin (HbA1c) > 6.5% and/or fasting glucose levels> 126 mg/dL (> 7 mmol/L) at screening
• Active liver or kidney disfunction at screening
• Other protocol-defined inclusion/exclusion criteria apply