Efficacy and Safety of VB119 in Subjects With Membranous Nephropathy
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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
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Condition or disease | Intervention/treatment | Phase |
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Membranous Nephropathy | Drug: VB119 | Phase 1 Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: VB119 dose escalation
Dose escalation phase followed by a dose expansion phase. VB119 to be administered as intravenous infusions.
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Drug: VB119
Humanized, immunoglobin (Ig) G1 monoclonal antibody (mAb) to be administered as intravenous infusion at multiple timepoints during the study. |
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: Through study completion, an average of 18 months ]Safety and Tolerability
- Incidence of Clinical Laboratory Assessments [ Time Frame: Through study completion, an average of 18 months ]Safety and Tolerability
- % of Patients with Anti-Drug Antibodies [ Time Frame: Through study completion, an average of 18 months ]
- Maximum Plasma Concentration [Cmax] [ Time Frame: Week 12 ]
- Time to Maximum Plasma Concentration [Tmax] [ Time Frame: Week 12 ]
- % of patients achieving complete remission of proteinuria [ Time Frame: Through study completion, an average of 18 months ]
- Anti-PLA2R Antibody Assessment [ Time Frame: Through study completion, an average of 18 months ]
- Quality of Life as assessed by PROMIS [ Time Frame: Through study completion, an average of 18 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
- 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.
Exclusion Criteria:
- 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;

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
Contact: Project Director | (301) 755-9900 | clinicaltrials@valenzabiotech.com |
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 |
Study Chair: | Keenan | ValenzaBio, Inc. |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Kidney Diseases Glomerulonephritis, Membranous Urologic Diseases Glomerulonephritis |
Nephritis Autoimmune Diseases Immune System Diseases |