Efficacy and Safety of VB119 in Subjects With Membranous Nephropathy

Inclusion Criteria

• •1. Is ≥ 18 years of age at the time of informed consent;
• •2. 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. 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;
• •4. Has systolic blood pressure (BP) \<160 mmHg or diastolic BP \<100 mmHg after 5 minutes of rest at Screening;
• •5. Is willing and able to provide written informed consent prior to Screening;
• •6. 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;
• •7. 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.
• •8. Male subjects must agree to abstain from sperm donation through 125 days after administration of the last dose of study drug.