Efficacy and Safety of VB119 in Subjects With Membranous Nephropathy

  • STATUS
    Recruiting
  • End date
    Oct 9, 2023
  • participants needed
    30
  • sponsor
    ValenzaBio, Inc.
Updated on 9 September 2021
monoclonal antibodies
treatment regimen
nephropathy
follicle stimulating hormone
proteinuria
kidney biopsy

Summary

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

Details
Condition Membranous glomerulonephritis, Glomerulonephritis, Autoimmune disease, membranous nephropathy
Treatment VB119
Clinical Study IdentifierNCT04652570
SponsorValenzaBio, Inc.
Last Modified on9 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Has proteinuria with a UPCR 3.5 g/g, based on 2 consecutive 24-hour urine 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

Exclusion Criteria

Has an eGFR <30 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 diabetes mellitus
Has an acute, chronic, or latent infection, including tuberculosis, hepatitis, HIV, or chronic urinary tract infections
Is positive for SARS-CoV-2 testing at Screening
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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