NCT04643470已完成2 期
A Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Zanubrutinib in Patients With Active Proliferative Lupus Nephritis
BeiGene44 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2020年12月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 44
- 主要终点
- Proportion of participants with complete renal response
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of zanubrutinib added to standard of care as measured by complete renal response for participants with active proliferative lupus nephritis
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics 2012 criteria.
- •ISN/RPS 2003 Class III/IV lupus nephritis [Type III(A), III (A+C), IV (A), and IV (A+C)], with or without Class V, as confirmed by a renal biopsy.
- •Positive antinuclear antibodies, positive anti-dsDNA autoantibody, and/or positive anti Smith autoantibody at screening
- •Has 24-hour urine protein excretion > 1.0 g at screening.
排除标准
- •Exclusion criteria related to systemic lupus erythematous and other diseases:
- •Glomerulonephritis caused by reasons other than systemic lupus erythematous.
- •Sclerosis in >50% of glomeruli on renal biopsy.
- •Any other inflammatory diseases that might confound the assessments of efficacy, including but not limited to rheumatoid arthritis, myositis, vasculitis, or overlapping syndrome.
- •Severe extrarenal SLE, including but not limited to severe pulmonary arterial hypertension, severe myocarditis, severe central nervous system lupus (such as neuropsychiatric SLE, seizures, psychosis, transverse myelitis, central nervous system vasculitis and optic neuritis), etc.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Zanubrutinib Medium Dose
Experimental
Participants will receive zanubrutinib 160 mg once daily (QD) for 72 weeks
干预措施: Zanubrutinib (Drug)
Zanubrutinib Low Dose
Experimental
Participants will receive zanubrutinib 40 mg twice daily (BID) for 72 weeks
干预措施: Zanubrutinib (Drug)
Zanubrutinib High Dose
Experimental
Participants will receive zanubrutinib 160 mg twice daily (BID) for 72 weeks
干预措施: Zanubrutinib (Drug)
Placebo
Experimental
Participants will receive placebo to match zanubrutinib for 72 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants with complete renal response
时间窗: Week 49 Day 1
次要结局
- Proportion of participants achieving complete renal response(Up to Week 73 Day 1)
- Proportion of participants achieving overall renal response(Up to Week 73 Day 1)
- Time to first overall renal response(Up to Week 73 Day 1)
- Proportion of participants achieving partial renal response(Up to Week 73 Day 1)
- Time to first complete renal response(Up to Week 73 Day 1)
- Change in total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score(Baseline to Week 49 Day 1)
- Area under plasma concentration time curve (AUC) of zanubrutinib(Week 1 Day 1 and Week 5 Day 1)
研究者
研究点 (44)
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