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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAmgen

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Glycated hemoglobin (HbA1c) > 6.5% and/or fasting glucose levels> 126 mg/dL (> 7 mmol/L) at screening.

Trial design

Treatments tested in this trial

  • AMG 732

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators