NCT05862233进行中（未招募）3 期
A Phase Ⅲ Clinical Study to Evaluate the Safety and Efficacy of MIL62 Injection in Participants With Primary Membranous Nephropathy
Beijing Mabworks Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年6月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Complete remission rate at Week 76
研究概览
简要总结
This study will evaluate the efficacy, safety, pharmacokinetics(PK) ,pharmacodynamics（PD）and anti-drug antibodies（ADA） of MIL62 compared with cyclosporine in participants with primary membranous nephropathy (pMN).
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening;
- •Screening 24-hour urinary protein >= 5 g after best supportive care for >= 3 months prior to screening or screening Screening 24-hour urinary protein > 3.5 g after best supportive care for >= 6 months prior to screening, or Screening 24-hour urinary protein > 3.5 g with at least one high-risk factor defined by the protocol;
- •Estimated glomerular filtration rate (eGFR ) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula ≥40 mL/min/1.73 m^2;
- •If taking ACEI(Angiotensin converting enzyme inhibitors), ARB(Angiotensin receptor blocker), a stable dose within 4 weeks before screening is required;
- •Sufficient organ function;
- •Able and willing to provide written informed consent and to comply with the study protocol.
排除标准
- •Participants with a secondary cause of MN;
- •Cyclosporine resistance;
- •Received treatment drugs for membranous nephropathy;
- •Concomitant with other serious diseases；
- •Received live vaccination, major surgery (excluding diagnostic procedures), and participated in other clinical trials within 28 days prior to receiving the first study drug;
- •Patients who are positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), with HBV DNA levels above the normal range (HBsAg and/or HBcAb-positive patients require regular HBV DNA testing); patients positive for hepatitis C virus (HCV) antibodies; or patients with a positive human immunodeficiency virus (HIV) serology.
- •Participants with CD4+ T lymphocyte count < 200 cells/μL;
- •Those who have a clear history of tuberculosis or have received anti- tuberculosis treatment;
- •Participants with known history of severe allergic reactions to humanized monoclonal antibodies, MIL62, or Cyclosporine
- •Breastfeeding or pregnant women;
- •Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method
- •Other conditions unsuitable for participation in this study determined by the Investigator.
研究组 & 干预措施
MIL62
Experimental
干预措施: MIL62 (Drug)
Cyclosporine
Active Comparator
干预措施: Cyclosporine (Drug)
MIL62
Experimental
干预措施: MIL62 (Drug)
Cyclosporine
Active Comparator
干预措施: Cyclosporine (Drug)
结局指标
主要结局
Complete remission rate at Week 76
时间窗: Week 76
The proportion of participants who achieved complete remission (CR) based on Urine Protein-to-Creatinine Ratio (UPCR) at week 76.
次要结局
- Complete Remission rate at Week 52.(Week 52)
- Complete remission rate and Overall remission rate at Week 24 and 104.(Week 24 and 104)
- Complete remission rate and Overall remission rate at Week 24，52，76 and 104.(Week 24，52，76 and 104)
- Time to Treatment Failure or Relapse after Overall remission(Up to 104 weeks)
- Change in efficacy indicators(Baseline to Week 104)
- Overall remission rate at Week 52 and 76.(Week 52 and 76)
- Change in quality of life(Baseline to Week 104)
- Percentage of Participants with Adverse Events (AEs)(up to 104 weeks)
- Percentage of Participants with AEs of Special Interest (AESIs)(Up to 104 weeks)
- Peripheral B-cell Counts at Specified Timepoints(Up to 104 weeks)
- Serum Concentrations of MIL62 at Specified Timepoints(Up to 104 weeks)
- Incidence of ADAs during the study(Up to 104 weeks)
研究者
研究点 (1)
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