A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Multi-dose Administration in Subjects With Systemic Lupus Erythematosus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 64
- 主要终点
- Incidence of treatment emergent adverse events
研究概览
简要总结
This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. All subjects will receive 4 weekly doses of study drug over a 3 week period, and then will be followed for an additional 28 weeks, for total study duration of 31 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 18 and 65 years old
- •Diagnosis of SLE
- •Stable disease; defined as no change in SLE therapy within the previous 30 days. Up to 5 mg/day incremental changes of prednisone therapy is allowed during the 30 days prior to randomization
- •SLE disease duration of at least 1 year, as diagnosed by a physician
排除标准
- •Current renal disease
- •Signs or symptoms of viral or bacterial infection within 30 days of enrollment
- •Any disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere the study evaluation, completion and/or procedures per the investigator's discretion
- •Administration of more than 10 mg/day prednison (or equivalent) in the 30 days prior to randomization
研究组 & 干预措施
AMG 623
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
干预措施: AMG 623 (Drug)
Placebo
Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events
时间窗: up to 31 weeks
Incidence of abnormal clinically significant vital signs
时间窗: up to 31 weeks
Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
时间窗: up to 31 weeks
Incidence of abnormal clinically significant ECG results
时间窗: up to 31 weeks
次要结局
- Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax(up to 31 weeks)