A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atacicept in Subjects With Lupus Nephritis in Combination With Mycophenolate Mofetil Therapy.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- EMD Serono
- 入组人数
- 6
- 试验地点
- 20
- 主要终点
- Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response
研究概览
简要总结
The purpose of this study is to learn whether atacicept treatment leads to improvement in kidney function in subjects with active lupus nephritis in combination with mycophenolate mofetil (MMF) and corticosteroids. The study was sponsored by Merck Serono International; operational oversight was provided by ZymoGenetics.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of systemic lupus erythematosus (SLE) satisfying at least 4 out of the 11 American College of Rheumatology (ACR) criteria (Appendix B)
- •Renal biopsy performed consistent with active International Society of Nephrology/Renal Pathology Society (ISN/PRS) class III or IV lupus nephritis
排除标准
- •Estimated glomerular filtration rate (GFR) less than or equal to (<=) 30 milliliter per minute (mL/min) per 1.73 square meter (m^2)
- •Active central nervous system SLE deemed to be severe or progressive and/or associated with significant cognitive impairment
- •Any treatment with MMF, azathioprine, or cyclophosphamide within the last 6 months, or known hypersensitivity to MMF or atacicept.
- •Any prior treatment with abatacept, rituximab, belimumab, or other B cell modulating agents.
研究组 & 干预措施
Placebo Plus Mycophenolate mofetil Plus Corticosteroids
干预措施: Mycophenolate mofetil (Drug)
Atacicept Plus Mycophenolate mofetil Plus Corticosteroids
干预措施: Atacicept (Drug)
Atacicept Plus Mycophenolate mofetil Plus Corticosteroids
干预措施: Mycophenolate mofetil (Drug)
Atacicept Plus Mycophenolate mofetil Plus Corticosteroids
干预措施: Corticosteroids (Drug)
Placebo Plus Mycophenolate mofetil Plus Corticosteroids
干预措施: Placebo (Drug)
Placebo Plus Mycophenolate mofetil Plus Corticosteroids
干预措施: Corticosteroids (Drug)
结局指标
主要结局
Percentage of Participants With Confirmed Complete Renal Response (CRR), Partial Response, and Non-response
时间窗: At Week 52
Complete renal response (CRR): from baseline, a return to within 10% of normal for renal function (assessed by calculated glomerular filtration rate \[GFR\]), improvement in proteinuria (urine protein/creatinine ratio \<0.5) \& resolution of hematuria. Partial response (PR): from baseline, a \<= 10% worsening in renal function ( by calculated GFR); 50% improvement in proteinuria (assessed by urine protein/creatinine ratio) \& resolution of hematuria, Non-response (NR): Neither criteria for CR or PR was met. Subjects were also deemed NR if they had treatment failure, regardless of CR or PR status. Subjects cannot be treatment failures. A response of CRR was confirmed if the Week 52 value is CRRand if the Week 48 value is CRR and at least 4 weeks apart from Week 52 /if the Week 48 value was missing/ less than 4 weeks from Week 52, then the Week 56 response must be CRR - if the Week 52 value was missing, then Week 48 and Week 56 must be CRR.
次要结局
- Percentage of Participants With Normalization of Renal Function(At Week 52)
- Number of Participants With New Lupus Flares(At Week 52)