2022-502227-22-00已完成2 期
A Phase 2b, Randomized, Controlled Double-blind, Multicenter Study Comparing the Efficacy and Safety of Zetomipzomib (KZR-616) 30 mg or 60 mg with Placebo in Patients with Active Lupus Nephritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 34
- 主要终点
- The primary efficacy endpoint is the proportion of patients achieving CRR at Week 37.
研究概览
简要总结
To evaluate the efficacy and safety of zetomipzomib in patients with active Class III or IV (with or without Class V; Class III/IV +/-V) LN and for those with pure Class V LN
研究设计
- 分配方式
- Randomized
- 主要目的
- Tbc
- 盲法
- Double (Subject, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Body mass index of ≥18 kg/m^2 eGFR ≥30 mL/min/1.73 m^2 Unequivocally positive ANA test result and/or a positive anti-dsDNA serum antibody test Diagnosis of LN according to 2003 or 2018 ISN/RPS criteria and confirmed by renal biopsy performed within 12 months prior to Screening. UPCR ≥1.0 (Class III/IV +/-V) or UPCR ≥2.0 (Class V) Adequate hematologic, hepatic, and renal function
排除标准
- •1.Current or medical history of: - Central nervous system manifestations of SLE - Overlapping autoimmune condition that may affect study assessments/outcomes - Antiphospholipid syndrome with history of thromboembolic event of within the 52 weeks prior to Screening - Thrombocytopenia or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies (i.e., plasmapheresis or acute blood or platelet transfusions - Solid organ transplant or planned transplant during study - Malignancy of any type, with exceptions for non-melanoma skin cancers and certain cancers >5 years ago
- •Has received dialysis within the 52 weeks prior to Screening
- •Positive test at Screening for HIV, hepatitis B/C
- •Known intolerance to MMF or equivalent and corticosteroids
结局指标
主要结局
The primary efficacy endpoint is the proportion of patients achieving CRR at Week 37.
The primary efficacy endpoint is the proportion of patients achieving CRR at Week 37.
次要结局
- The key secondary efficacy endpoints will evaluate the proportion of patients achieving the following: • PRR at Week 25, Week 37, and Week 53 • CRR at Week25 and Week 53 The other secondary efficacy endpoints include the following: • Percentage change from Baseline in UPCR by visit • Time to event (CRR, PRR, death or renal event)
- • Proportion of patients achieving CRR (at Weeks 25, 37, and 53) with successful taper of prednisone or equivalent by Week 17 • Proportion of patients achieving CRR (at Weeks 25, 37, and 53) with no use of prednisone or equivalent during the 8 weeks prior to the renal response assessment • Proportion of patients with UPCR ≤0.5 at Weeks 13, 25, 37, and 53
- • Proportion of patients achieving CRR with UPCR ≤ upper limit of normal (ULN) at Weeks 25, 37, and 53 • Change from Baseline in clinical Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score, excluding complement and anti-dsDNA components • Change from Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L)
研究者
Clinical Operations
Scientific
Kezar Life Sciences Inc.
研究点 (34)
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