jRCT2071230031招募中不适用
A MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, DOUBLE-BLIND PHASE III CLINICAL TRIAL OF OBINUTUZUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 主要终点
- SRI(4)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 75age old under（—）
- 性别
- All
入选标准
- •(1)Patients living in Japan aged 18-75 years
- •(2)Diagnosis of SLE according to the 2019 EULAR/ACR Classification Criteria >12 weeks prior to screening
- •(3)ANA >1:80, or anti-dsDNA and/or anti-Sm antibodies above the upper limit of normal (ULN)
- •(4)Low C3 and/or low C4 and/or low CH50 complement
- •(5)High disease activity at screening, as defined by all of the following:
- •BILAG-2004: Category A disease in >1 organ system and/or Category B disease in >2 organ systems
- •SLEDAI-2K: score >8
- •Physician`s Global Assessment (PGA): score >1.0 on a 0 to 3 Visual Analog Scale (VAS)
- •(6)Current receipt of >1 of the following classes of standard therapies for the treatment of SLE at stable doses: OCS, antimalarials, conventional immunosuppressants
排除标准
- •(1)Presence of significant lupus-associated renal disease and/or renal impairment
- •(2)Active severe or unstable lupus-associated neuropsychiatric disease
- •(3)Receipt of any of the following excluded therapies:
- •Any B-cell depleting (e.g., anti-CD20, anti-CD19) or anti-plasma cell therapy such as, but not limited to, obinutuzumab, rituximab, ofatumumab, or bortezomib less than 9 months prior to Day1
- •Cyclophosphamide less than 3 months prior to Day1
- •Calcineurin inhibitor (ciclosporin, voclosporin) less than 4 weeks prior to Day1
- •Any biologic therapy (drugs other than B cell or plasma cell depleting drugs that may affect the safety of subjects or evaluation of this study) such as, but not limited to, belimumab, ustekinumab, anifrolumab, secukinumab, or atacicept less than 2 months prior to Day1
- •Any live vaccine less than 28 days prior to Day1
结局指标
主要结局
SRI(4)
时间窗: Week 52
To evaluate the efficacy of obinutuzumab when combined with standard-of-care therapy (the proportion of participants who achieve SRI(4) at Week 52). SRI(4) is defined as achievement of all of the following: - Reduction from baseline of >4 points in the SLEDAI-2K - No new systems or organs affected, as defined by >1 new BILAG A or >2 new BILAG B items compared with baseline using BILAG-2004 - No worsening from baseline of >0.3 points on a 3-point PGA-VAS
次要结局
- Proportion of participants who achieve BICLA at Week 52(Week 52)
- Proportion of participants who achieve LLDAS at Week 52(Week 52)
- Proportion of participants who achieve SRI(6) at Week 52(Week 52)
研究者
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