NCT07438405招募中2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- 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
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
AMG 732
Experimental
Participants will receive AMG 732 subcutaneously (SC)
干预措施: AMG 732 (Drug)
结局指标
主要结局
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
时间窗: Week 24
Responders are defined as participants with a ≥ 2 mm reduction from baseline in the trial eye without deterioration (≥ 2 mm increase) of proptosis in the fellow eye.
次要结局
- 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(Baseline and Week 24)
- Time to Cmax (tmax) of AMG 732(Baseline to 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(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(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(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(Baseline and Week 24)
- Trough Concentration (Ctrough) of AMG 732(Baseline to Week 24)
- Maximum Observed Concentration (Cmax) of AMG 732(Baseline to Week 24)
- Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 732(Baseline to Week 24)
- Half-life (t1/2) of AMG 732(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)(Up to Week 48)
研究者
研究点 (8)
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