JPRN-jRCT2080224123已完成2 期
A placebo-controlled, patient and investigator blinded, randomized parallel cohort study to assess pharmacodynamics, pharmacokinetics, safety, tolerability and preliminary clinical efficacy of VAY736 and CFZ533 in patients with systemic lupus erythematosus (SLE)
ovartis Pharma K.K.0 个研究点目标入组 120 人开始时间: 2018年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Fulfill 4 or more of the 11 American College of Rheumatology 1997 classification criteria for SLE
- •- SLEDAI-2K score of 6 or higher
- •- BILAG 2004 score of 1A or higher, or 2B or higher in mucocutaneous domain
排除标准
- •- Presence of WHO Class III-IV renal involvement with proliferative disease or nephrotic range proteinuria (above 2 g/day) requiring immune suppressive treatment exceeding protocol-defined limits
- •- Active viral, bacterial or other infections, or history of recurrent clinically significant infection or of recurrent bacterial infections with encapsulated organisms
- •- Receipt of live/attenuated vaccine within a 2-month period before first dosing
- •- Pregnant or nursing (lactating) women
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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