Efficacy and Safety of VB119 in Subjects With Membranous Nephropathy

Membranous Nephropathy Clinical Trial

Official title:

A Phase 1b/2a Study of VB119 in Adult Subjects With Primary Membranous Nephropathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04652570
• Other study ID #: 119-01-01
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: May 5, 2021
• Est. completion date: August 15, 2024

Study information

• Verified date: February 2024
• Source: Tenet Medicines
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: August 15, 2024
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Glomerulonephritis, Membranous
• Kidney Diseases
• Membranous Nephropathy

Intervention

Drug:
• VB119
Humanized, immunoglobin (Ig) G1 monoclonal antibody (mAb) to be administered as intravenous infusion at multiple timepoints during the study.

Locations

Country	Name	City	State
United States	Clinical Research Site	Albany	New York
United States	Clinical Research Site	Bethlehem	Pennsylvania
United States	Clinical Research Site	Dallas	Texas
United States	Clinical Reserach Site	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Tenet Medicines

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events	Safety and Tolerability	Through study completion, an average of 18 months
Primary	Incidence of Clinical Laboratory Assessments	Safety and Tolerability	Through study completion, an average of 18 months
Secondary	% of Patients with Anti-Drug Antibodies		Through study completion, an average of 18 months
Secondary	Maximum Plasma Concentration [Cmax]		Week 12
Secondary	Time to Maximum Plasma Concentration [Tmax]		Week 12
Secondary	% of patients achieving complete remission of proteinuria		Through study completion, an average of 18 months
Secondary	Anti-PLA2R Antibody Assessment		Through study completion, an average of 18 months
Secondary	Quality of Life as assessed by PROMIS		Through study completion, an average of 18 months