An Open-label, Rollover Study for Participants With Thyroid Eye Disease Previously Enrolled in Amgen-sponsored AMG 732 Studies and Are Primary Proptosis Non-responders or Who Relapsed During the Safety Follow-up
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).
• 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.