NCT05394857终止2 期
A Single-arm, Open-label, Prospective Phase II Study to Evaluate the Efficacy and Safety of SHR-1314 by Subcutaneous Injection in Active Moderate to Severe Graves' Orbitopathy Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- the proptosis responder rate
研究概览
简要总结
This is a single-arm, prospective, open-label, Phase II study that explored the efficacy and safety of SHR-1314 in active moderate to severe Graves' Orbitopathy. The study consists of a 6-week screening period, a 16-week treatment period, and a 12-week follow-up period. Eighteen adult patients with active moderate to severe Graves' Orbitopathy will be enrolled. Eligible subjects will receive SHR-1314 subcutaneously. The primary endpoint was the proptosis responder rate and will be evaluated at 16weeks.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
- •Male or female between the ages of 18 and 70 (including boundary values)
- •Onset of active GO symptoms fewer than 9 months prior to baseline.
- •Clinical diagnosis of Graves' disease associated with active GO with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye(study eye) at Screening and Baseline.
- •Moderate-to-severe active GO (not sight-threatening but has an appreciable impact on daily life).
- •Does not require immediate surgical ophthalmological intervention.
排除标准
- •Pregnant or lactating women.
- •allergy to the study drug or to any component of the study drug.
- •Significant abnormalities in laboratory and ECG.
- •Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
- •Corneal decompensation unresponsive to medical management.
- •Decrease in CAS of ≥ 2 points between Screening and Baseline.
- •Decrease in proptosis of ≥ 2 mm between Screening and Baseline.
- •Previous orbital irradiation or surgery for TED.
- •Any other ophthalmic disease that might interfere the study or the study result confirmed by investigator.
- •Patients with serious, progressive and uncontrolled cardiovascular, liver, kidney, lung, gastrointestinal, hematopoietic, endocrine, nervous and psychiatric diseases, or other conditions that considered inappropriate for patients to participate this study.
研究组 & 干预措施
Treatment group
Experimental
SHR-1314 s.c
干预措施: SHR-1314 (Drug)
结局指标
主要结局
the proptosis responder rate
时间窗: week 16
Proptosis responder is defined as a ≥ 2 mm reduction from Baseline in proptosis in the study eye, without deterioration \[≥ 2 mm increase\] of proptosis in the fellow eye)
次要结局
- Diplopia response rate at Week16(week 16)
- The percentage of subjects with a CAS value of 0 or 1 in the study eye(week 16)
- The mean change from Baseline to Week 16 in the GO-QoL score(week 16)
- The mean change from Baseline to Week 16 in proptosis measurement in the study eye(week 16)
- Proportion of patients achieving response in reduction of clinical activity score(CAS)(week 16)
- Overall responder rate(week 16)
研究者
研究点 (1)
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