Efficacy and Safety of VB119 in Subjects With Membranous Nephropathy

Last updated: February 15, 2024
Sponsor: Tenet Medicines
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Nephrotic Syndrome

Kidney Disease

Nephritis

Treatment

VB119

Clinical Study ID

NCT04652570
119-01-01
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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: Itis preferable that subjects enrolled have kidney biopsy tissue samples that arepositive for anti-PLA2R antibody staining. Subjects with kidney biopsy-provendiagnosis of primary MN >10 years and ≤20 years that meet all other eligibilitycriteria may be enrolled after discussion with the Medical Monitor.
    1. Has a documented laboratory history of nephrotic range proteinuria (defined aseither greater than or equal to 3.5 g total protein per 24-hour urine collection orgreater than or equal to 3.5 g/g UPCR by spot collection) AND has proteinuria with aUPCR greater than or equal to 2.0 g/g based on 2 consecutive spot urine (first morningvoid) sample collections obtained within 14 days of each other during the ScreeningPeriod. Both samples must qualify;
  3. Has systolic blood pressure (BP) <160 mmHg or diastolic BP <100 mmHg after 5 minutesof rest at Screening;
  4. Is willing and able to provide written informed consent prior to Screening;
  5. Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomyat least 26 weeks before the Screening Visit) or postmenopausal, defined asspontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone in thepostmenopausal range at Screening, based on the central laboratory's ranges;
  6. Female subjects of childbearing potential (ie, ovulating, premenopausal, or notsurgically sterile) and all male subjects must use a medically accepted, highlyeffective contraceptive regimen during their participation in the study and for 125days after the last administration of study drug.
  7. Male subjects must agree to abstain from sperm donation through 125 days afteradministration of the last dose of study drug.

Exclusion

Exclusion Criteria:

  1. Has an eGFR <45 mL/min/1.73 m2 at Screening utilizing the Chronic Kidney DiseaseEpidemiology Collaboration formula confirmed by the central laboratory;
  2. Has an absolute neutrophil count <1.5 x 10/L;
  3. Has a white blood cell count <3.0 x 10/L;
  4. Has secondary causes of MN (eg, malignancy, hepatitis B or C, human immunodeficiencyvirus [HIV], systemic lupus erythematosus [SLE], or other autoimmune diseases [eg,thyroiditis], drug-induced);
  5. Has a diagnosis or history of SLE (including non renal disease);
  6. Has type 1 or 2 diabetes mellitus;
  7. Has an acute, chronic, or latent infection, including tuberculosis, hepatitis, HIV, orchronic urinary tract infections;

Study Design

Total Participants: 6
Treatment Group(s): 1
Primary Treatment: VB119
Phase: 1/2
Study Start date:
May 05, 2021
Estimated Completion Date:
August 15, 2024

Connect with a study center

  • ValenzaBio Investigative Site

    Aguascalientes,
    Mexico

    Site Not Available

  • ValenzaBio Investigative Site

    Monterrey,
    Mexico

    Site Not Available

  • ValenzaBio Investigative Site

    Oaxaca,
    Mexico

    Site Not Available

  • ValenzaBio Investigative Site

    Cambridge, CB2 2QQ
    United Kingdom

    Site Not Available

  • ValenzaBio Investigative Site

    Leicester, LE5 4PW
    United Kingdom

    Site Not Available

  • ValenzaBio Investigative Site

    London, W12 OHS
    United Kingdom

    Site Not Available

  • ValenzaBio Investigative Site

    Sheffield, S5 7AU
    United Kingdom

    Site Not Available

  • ValenzaBio Investigative Site

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    Granada Hills, California 91344
    United States

    Site Not Available

  • Clinical Reserach Site

    Los Angeles, California 91324
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    Mission Viejo, California 92691
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    Northridge, California 91324
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    San Francisco, California 94143
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    Vacaville, California 95687
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    Chicago, Illinois 60611
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    Shreveport, Louisiana 71101
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    Ann Arbor, Michigan 48084
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    Pontiac, Michigan 48341
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Clinical Research Site

    Albany, New York 12209
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Clinical Research Site

    Bethlehem, Pennsylvania 18017
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    Columbia, South Carolina 29201
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • Clinical Research Site

    Dallas, Texas 75208
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    Lewisville, Texas 75057
    United States

    Site Not Available

  • ValenzaBio Investigative Site

    San Antonio, Texas 78215
    United States

    Site Not Available

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