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Efficacy and Safety of VB119 in Subjects With Membranous Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04652570
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
ValenzaBio, Inc.

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Membranous Nephropathy Drug: VB119 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2a Study of VB119 in Adult Subjects With Primary Membranous Nephropathy
Actual Study Start Date : May 5, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: VB119 dose escalation
Dose escalation phase followed by a dose expansion phase. VB119 to be administered as intravenous infusions.
 Drug: VB119
Humanized, immunoglobin (Ig) G1 monoclonal antibody (mAb) to be administered as intravenous infusion at multiple timepoints during the study.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Through study completion, an average of 18 months ]
    Safety and Tolerability

  2. Incidence of Clinical Laboratory Assessments [ Time Frame: Through study completion, an average of 18 months ]
    Safety and Tolerability


Secondary Outcome Measures :
  1. % of Patients with Anti-Drug Antibodies [ Time Frame: Through study completion, an average of 18 months ]
  2. Maximum Plasma Concentration [Cmax] [ Time Frame: Week 12 ]
  3. Time to Maximum Plasma Concentration [Tmax] [ Time Frame: Week 12 ]
  4. % of patients achieving complete remission of proteinuria [ Time Frame: Through study completion, an average of 18 months ]
  5. Anti-PLA2R Antibody Assessment [ Time Frame: Through study completion, an average of 18 months ]
  6. Quality of Life as assessed by PROMIS [ Time Frame: Through study completion, an average of 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion Criteria:

  1. Has an eGFR <45 mL/min/1.73 m2 at Screening utilizing the Chronic Kidney Disease Epidemiology 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 immunodeficiency virus [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, or chronic urinary tract infections;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652570


Contacts
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Contact: Project Director (301) 755-9900 clinicaltrials@valenzabiotech.com

Locations
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United States, Alabama
ValenzaBio Investigative Site Recruiting
Birmingham, Alabama, United States, 35233
United States, California
ValenzaBio Investigative Site Recruiting
Granada Hills, California, United States, 91344
ValenzaBio Investigative Site Recruiting
Mission Viejo, California, United States, 92691
ValenzaBio Investigative Site Recruiting
Northridge, California, United States, 91324
ValenzaBio Investigative Site Recruiting
Vacaville, California, United States, 95687
United States, District of Columbia
ValenzaBio Investigative Site Recruiting
Washington, District of Columbia, United States, 20037
United States, Louisiana
ValenzaBio Investigative Site Recruiting
Shreveport, Louisiana, United States, 71101
United States, Michigan
ValenzaBio Investigative Site Recruiting
Pontiac, Michigan, United States, 48341
United States, New York
ValenzaBio Investigative Site Recruiting
Albany, New York, United States, 12209
United States, North Carolina
ValenzaBio Investigative Site Recruiting
Greenville, North Carolina, United States, 27834
United States, Pennsylvania
ValenzaBio Investigative Site Recruiting
Bethlehem, Pennsylvania, United States, 18017
United States, Rhode Island
ValenzaBio Investigative Site Recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
ValenzaBio Investigative Site Recruiting
Orangeburg, South Carolina, United States, 29118
United States, Texas
ValenzaBio Investigative Site Recruiting
Dallas, Texas, United States, 75208
United Kingdom
ValenzaBio Investigative Site Recruiting
Cambridge, United Kingdom, CB2 2QQ
ValenzaBio Investigative Site Not yet recruiting
Leicester, United Kingdom, LE5 4PW
ValenzaBio Investigative Site Recruiting
London, United Kingdom, W12 OHS
ValenzaBio Investigative Site Not yet recruiting
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
ValenzaBio, Inc.
Investigators
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Study Chair: Keenan ValenzaBio, Inc.
More Information
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Responsible Party: ValenzaBio, Inc.
ClinicalTrials.gov Identifier: NCT04652570    
Other Study ID Numbers: 119-01-01
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Glomerulonephritis
 Nephritis
Autoimmune Diseases
Immune System Diseases