Efficiency of Baracetinib to Induce Remission of Active Lupus Nephritis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Album in urine
研究概览
简要总结
Patients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus and had a diagnosis of systemic lupus erythematosus, and had active renal disease as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug.
详细描述
Patients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus and had a diagnosis of systemic lupus erythematosus, and had active renal disease as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug.
The baricitinib 4 mg dose suggestive to significantly improved the signs and symptoms of active systemic lupus erythematosus in patients who were not adequately controlled despite standard of care therapy, with a safety profile consistent with previous studies of baricitinib. This study provides the idea for future trials of JAK1/2 inhibition with baricitinib as a new potential oral therapy for
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)
盲法说明
patient and outcome assessor
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lupus nephritis
排除标准
- •cardiac disease Thrombosis
研究组 & 干预措施
Baracetinib
oral tablet 4 mg baricitinib and placebo IV infusion/ month
干预措施: Anti JAK1,2 (Drug)
Cyclophosphamide
IV cyclophosphamide 0.7mg/m2 every month and placebo tablet daily
干预措施: Cyclophosphamid (Drug)
结局指标
主要结局
Album in urine
时间窗: 6 months
24 h protein in urine
次要结局
- lupus activity index-2K(3 and 6 months)
- anti double strand DNA(3 and 6 months)
- complement 3(3 and 6 months)
研究者
Manal Hassanien
Associate Professor
Assiut University