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

Официальное название

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

Обзор

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).

Вмешательства

• Препарат AMG 732
  AMG 732 will be administered SC.

Первичные конечные точки

• Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who are Defined as Primary Nonresponders or Relapsed During the Safety Follow-up in the Parent Trial [Срок оценки: Week 24]

Вторичные конечные точки (11)

• Change from Baseline at Week 24 in Proptosis Measurement by an Exophthalmometer in the Trial Eye in Participants with TED who are Defined as Primary Nonresponders or Relapsed During the Safety Follow-up in the Parent Trial [Срок оценки: Baseline and Week 24]
• Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who had Relapse after Achieving Proptosis Response in the Parent Trial [Срок оценки: Week 24]
• Change from Baseline at Week 24 in Proptosis Measurement by an Exophthalmometer in the Trial Eye in Participants with TED who had Relapse after Achieving Proptosis Response in the Parent Trial [Срок оценки: Baseline and Week 24]
• Number of Participants who are Proptosis Responders in the Trial Eye at Week 24 in Participants with TED who were Defined as Primary Nonresponders in the Parent Trial [Срок оценки: Week 24]
• Change from Baseline at Week 24 in Proptosis Measurement by an Exophthalmometer in the Trial Eye in Participants with TED who were Defined as Primary Nonresponders in the Parent Trial [Срок оценки: Baseline and Week 24]
• Trough Concentration (Ctrough) of AMG 732 [Срок оценки: Baseline to Week 24]
• Maximum Observed Concentration (Cmax) of AMG 732 [Срок оценки: Baseline to Week 24]
• Time to Cmax (tmax) of AMG 732 [Срок оценки: Baseline to Week 24]
• Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 732 [Срок оценки: Baseline to Week 24]
• Half-life (t1/2) of AMG 732 [Срок оценки: Baseline to Week 24]
• Number of Participants with Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESEAs), Adverse Events Leading to Investigational Product Discontinuation and Events of Interest (EOIs) [Срок оценки: Up to Week 48]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.
• 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.
• Active liver or kidney disfunction at screening.
• 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.
• 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.
• History or existing inflammatory bowel disease (ulcerative colitis or Crohn's disease).
• Other protocol-defined inclusion/exclusion criteria apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 4 центра

• Applied Research Center of Arkansas — Little Rock
• Ilumina Medical Research — Kissimmee
• Vision Medical Research, Inc. — Orland Park
• West Virginia University — Morgantown

Испания · 2 центра

• Hospital Universitario Virgen Macarena — Seville
• Hospital Universitari i Politecnic La Fe — Valencia

Польша · 1 центр

• Eb Group Spolka z ograniczona odpowiedzialnoscia — Warsaw

Тайвань · 1 центр

• National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT07438405 · 20230294

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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