A Phase1/2, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Pharmacokinetics of One 12 Week Treatment Cycle of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects With Moderate to Severe Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 20
- 试验地点
- 7
- 主要终点
- Area under the concentration time curve (AUC)
研究概览
简要总结
The primary objective of the study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of Epratuzumab in Japanese subjects with moderate to severe general SLE as add on to standard of care treatment during the trial.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive Anti-nuclear Antibody (ANA) at Screening (Visit 1)
- •Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria
- •Active moderate to severe SLE activity as demonstrated by British Isles Lupus Assessment Group Index (BILAG)
- •Active moderate to severe SLE disease as demonstrated by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score on stable SLE treatment
排除标准
- •Subjects who are breastfeeding, pregnant, or plan to become pregnant
- •Subjects with active, severe SLE disease activity which involves the renal system and active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A
- •Serious infections
结局指标
主要结局
Area under the concentration time curve (AUC)
时间窗: From baseline to 12 weeks
AUC is defined as the area under the plot of plasma concentration of Epratuzumab against time after administration per subject. All measurements taken in the study (at administration day \[day 0, 7, 14, 21\] and the next four days of each administration day and week-4, 6, 8, 10, 12) are used to calculate AUC
Half-life (t1/2)
时间窗: From baseline to 12 weeks
Half-life is defined as the time taken for plasma concentrations of Epratuzumab to decline by one half per subject. All measurements taken in the study (at administration day \[day 0, 7, 14, 21\] and the next four days of each administration day and week-4, 6, 8, 10, 12) are used to calculate Half-life.
Maximum plasma Concentration (Cmax)
时间窗: From Baseline to 12 weeks
Plasma concentration of Epratuzumab for each pharmacokinetics parameter is measured at administration day (day 0, 7, 14, 21) and the next four days of each administration day and week-4, 6, 8, 10, 12.
次要结局
- Incidence of anti-epratuzumab in plasma during administration over 12 weeks(Day 0 (initial administration day) and week 12 (end of the evaluation period))