NCT04652570终止1 期
A Phase 1b/2a Study of VB119 in Adult Subjects With Primary Membranous Nephropathy
Tenet Medicines4 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2021年5月5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
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
This study is a Phase 1b/2a, open-label, sequential-cohort, dose escalation, and dose expansion study to evaluate the safety, tolerability, PK, and PD of VB119 in subjects with primary MN
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is ≥ 18 years of age at the time of informed consent;
- •Has a kidney biopsy-proven diagnosis of primary MN within the past 10 years; Note: It is preferable that subjects enrolled have kidney biopsy tissue samples that are positive for anti-PLA2R antibody staining. Subjects with kidney biopsy-proven diagnosis of primary MN >10 years and ≤20 years that meet all other eligibility criteria may be enrolled after discussion with the Medical Monitor.
- •3. Has a documented laboratory history of nephrotic range proteinuria (defined as either greater than or equal to 3.5 g total protein per 24-hour urine collection or greater than or equal to 3.5 g/g UPCR by spot collection) AND has proteinuria with a UPCR greater than or equal to 2.0 g/g based on 2 consecutive spot urine (first morning void) sample collections obtained within 14 days of each other during the Screening Period. Both samples must qualify;
- •Has systolic blood pressure (BP) <160 mmHg or diastolic BP <100 mmHg after 5 minutes of rest at Screening;
- •Is willing and able to provide written informed consent prior to Screening;
- •Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone in the postmenopausal range at Screening, based on the central laboratory's ranges;
- •Female subjects of childbearing potential (ie, ovulating, premenopausal, or not surgically sterile) and all male subjects must use a medically accepted, highly effective contraceptive regimen during their participation in the study and for 125 days after the last administration of study drug.
- •Male subjects must agree to abstain from sperm donation through 125 days after administration of the last dose of study drug.
排除标准
- •Has an eGFR <45 mL/min/1.73 m2 at Screening utilizing the Chronic Kidney Disease Epidemiology Collaboration formula confirmed by the central laboratory;
- •Has an absolute neutrophil count <1.5 x 10/L;
- •Has a white blood cell count <3.0 x 10/L;
- •Has secondary causes of MN (eg, malignancy, hepatitis B or C, human immunodeficiency virus [HIV], systemic lupus erythematosus [SLE], or other autoimmune diseases [eg, thyroiditis], drug-induced);
- •Has a diagnosis or history of SLE (including non renal disease);
- •Has type 1 or 2 diabetes mellitus;
- •Has an acute, chronic, or latent infection, including tuberculosis, hepatitis, HIV, or chronic urinary tract infections;
研究组 & 干预措施
VB119 dose escalation
Experimental
Dose escalation phase followed by a dose expansion phase. VB119 to be administered as intravenous infusions.
干预措施: VB119 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: Through study completion, an average of 18 months
Safety and Tolerability
Incidence of Clinical Laboratory Assessments
时间窗: Through study completion, an average of 18 months
Safety and Tolerability
次要结局
- % of Patients with Anti-Drug Antibodies(Through study completion, an average of 18 months)
- Anti-PLA2R Antibody Assessment(Through study completion, an average of 18 months)
- Quality of Life as assessed by PROMIS(Through study completion, an average of 18 months)
- Maximum Plasma Concentration [Cmax](Week 12)
- % of patients achieving complete remission of proteinuria(Through study completion, an average of 18 months)
- Time to Maximum Plasma Concentration [Tmax](Week 12)
研究者
研究点 (4)
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