NCT01764594已完成1 期
A Multicenter, Investigator- and Subject-Blind, Randomized, Placebo-Controlled, Parallel-Group, Repeat-Dose Study to Evaluate the Effect of CDP7657 in Subjects With Active Systemic Lupus Erythematosus
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 24
- 试验地点
- 21
- 主要终点
- Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study
研究概览
简要总结
To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Systemic Lupus Erythematosus (SLE)
排除标准
- •Severe neuropsychiatric or severe renal Systemic Lupus Erythematosus (SLE)
- •History of chronic, recurrent, or recent severe infection
- •Significant hematologic abnormalities
- •History of cancer, heart failure, renal disease, liver disease or other serious illness
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
CDP7657
Experimental
CDP7657 100 mg/ ml solution
30 mg/ kg initial dose
15 mg/ kg every other week
10 weeks
干预措施: CDP7657 (Biological)
结局指标
主要结局
Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study
时间窗: 0 - 28 Weeks
Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study
时间窗: 0 - 28 Weeks
次要结局
- Maximum plasma concentration (Cmax)(0 - 28 Weeks)
- Predose plasma concentration (Ctrough)(0 - 28 Weeks)
- Area under the concentration-time curve over the dosing interval (AUCτ)(0 - 28 Weeks)
研究者
研究点 (21)
Loading locations...
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