NCT05800873已完成1 期
A Phase 1b/2 Study To Evaluate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of EVER001 In Participants With Selected Proteinuric Glomerular Diseases
Everest Medicines (China) Co.,Ltd.34 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2023年5月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 34
- 主要终点
- adverse events
研究概览
简要总结
EVER001 is a highly selective, oral, reversable, covalent Bruton tyrosine kinase (BTK) inhibitor with high selectivity over other kinases, which is being developed to treat proteinuric glomerular diseases.
The overall aim of the study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of EVER001 in subjects with selected proteinuric glomerular diseases. The first targeted disease is primary membranous nephropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having clinical diagnosis of primary membranous nephropathy, as verified by biopsy.
- •Have positive anti-PLA2R autoantibody test results > 20 relative units (RU)/ml.
- •During screening at least one testing of proteinuria must be >3.5 g/24h.
- •Have nephrotic range proteinuria for at least 8 weeks prior to Day 1 and no improvement (<50% reduction) despite supportive therapy of ACE inhibitor or ARB unless contraindicated, for patients who have two tests of proteinuria during screening ≥8.0g/24h, the duration of nephrotic range proteinuria for at least 8 weeks is not required.
排除标准
- •Non-primary membranous nephropathy or other condition affecting the kidney.
- •eGFR at screening < 45 mL/min/1.73m2 or kidney function not stable .
- •Uncontrolled hypertension .
- •Serum albumin level at screening # 25g/l.
- •Have received: B-cell targeted therapy except rituximab at any time;Rituximab and the biosimilars within 2 years (participants with rituximab treatment between 1 and 2 years prior to Day 1 are eligible if there is documented evidence of B-cell repopulation to >90% of Lower Limits of Normal Range.); Cyclophosphamide or Chlorambucil within 180 days;other immunosuppressive/immunomodulatory agents within 90 days;greater than 30mg/day prednisone or equivalence within 30 days.
- •Acute or chronic infection,including positivity of tuberculosis infection test.
- •Positive serology for TP,HIV, HBV, or HCV.
- •Lab testing abnormality as: WBC< 3000/mm³, Lymphocyte < 1000/ mm³, neutrophil <1500/mm³, Hb < 80g/L, Platelet count <100×10e9/ L, Prothrombin time>1.5×ULN, Activated partial thromboplastin time ≥1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≥ 1.5×ULN, alkaline phosphatase and bilirubin >1.5×ULN.
- •Judged by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
研究组 & 干预措施
EVER001 200mg
Experimental
EVER001 200mg BID for 36 weeks.
干预措施: EVER001 (Drug)
EVER001 100mg
Experimental
EVER001 100mg QD for 4 weeks, followed by EVER001 100mg BID for 32 weeks.
干预措施: EVER001 (Drug)
结局指标
主要结局
adverse events
时间窗: 104 weeks.
clinical laboratory assessments.
时间窗: 104 weeks.
vital signs.
时间窗: 104 weeks.
ECG.
时间窗: 104 weeks.
physical examination
时间窗: 104 weeks
次要结局
- To evaluate whether EVER001 can modulate proteinuria in pMN.(52 weeks.)
- To evaluate the clinical response and immunological response in pMN.(104 weeks.)
- Maximum Observed Plasma Concentration (Cmax) of EVER001(52 weeks.)
- Minimum Observed Plasma Concentration (Cmin) of EVER001(52 weeks.)
- Time to Reach Maximum Observed Concentration (Tmax) of EVER001.(52 weeks.)
- To evaluate whether EVER001 can modulate anti-PLA2R autoantibodies in patients with positive baseline levels of these antibodies.(52 weeks.)
研究者
研究点 (34)
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