EUCTR2013-002773-21-CZ进行中（未招募）1 期
A Phase IIb, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multidose, 24-Week Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With Systemic Lupus Erythematosus (SLE)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 279
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female of =18 years of age, who provide written informed
- •consent at screening
- •- SLEDAI-2K score =6 at screening
- •- Diagnosis of SLE satisfying at least 4 out of the 11 ACR classification
- •criteria for SLE during the course of their illness at screening
- •- Disease duration of at least 6 months from the time of diagnosis (when
- •the subject met at least 4 of the ACR criteria) at screening
- •- Positive test results for ANA (human epithelial cell [Hep]-2 ANA = or
- •>1:80) and/or anti-dsDNA antibody (=30 IU/mL) at screening
- •- Other protocol defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 265
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •- History or current diagnosis of any demyelinating disease
- •- Active central nervous system SLE deemed to be severe or progressive
- •- Use of cyclophosphamide within 3 months before or during SV
- •- Active, moderate to severe glomerulonephritis and/or severe renal impairment (spot urine protein:creatinine ratio [UPCr] =2 mg/mg
- •-Other protocol defined exclusion criteria may apply
研究者
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