Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS)

A Phase 2 Study of VB119 in Adult Subjects With Steroid-Sensitive Primary Minimal Change Disease (MCD) or Primary Focal Segmental Glomerulosclerosis (FSGS)

Phase 2, multi-center, proof-of-concept study to evaluate the safety and efficacy of VB119 on the maintenance of remission and duration of response in adults with primary MCD or primary FSGS who previously responded to steroid therapy.

Study Overview

• Status: Terminated
• Conditions: Focal Segmental Glomerulosclerosis; Minimal Change Disease
• Intervention / Treatment: Drug: VB119

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Clinical Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Is ≥ 18 years of age at the time of informed consent;
2. Kidney biopsy-proven diagnosis of primary MCD or primary FSGS within the past 10 years. Subjects with kidney biopsy-proven diagnosis of primary MCD or primary FSGS greater than 10 years and less than 20 years prior to Screening who meet all other eligibility criteria may be enrolled after discussion with the Medical Monitor
3. History of steroid-sensitive MCD or FSGS, defined as having achieved complete remission of proteinuria (reduction of proteinuria to <0.5 g/g UPCR) after use of corticosteroids;
4. Has experienced meaningful proteinuria in the last 2 years prior to Screening, defined as UPCR >2.0 g/g, after attempted or completed tapering of steroids and/or CNIs that occurs within 6 months of the attempt or completion of tapering;
5. Currently on prednisone regimen at time of Screening and anticipated to be tapered to a stable dose of prednisone of no more than 20 mg/day for at least 14 days prior to Day 1
6. Has systolic blood pressure (BP) <160 mmHg or diastolic BP <100 mmHg after 5 minutes of rest at Screening;
7. Is willing and able to provide written informed consent prior to Screening;
8. 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;
9. 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 (4 months) after the last administration of study drug.
10. Male subjects must agree to abstain from sperm donation through 125 days (4 months) after administration of the last dose of study drug.

Exclusion Criteria:

1. Has an estimated glomerular filtration rate (eGFR) <60 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 MCD or FSGS (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 infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VB119; VB119 100 or 200mg IV doses administered 4 times	Drug: VB119; Humanized, immunoglobin (Ig) G1 monoclonal antibody (mAb) to be administered as intravenous infusion at multiple timepoints during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects in remission at End of Treatment	Efficacy	Day 274
Incidence of serious adverse events (SAEs)	Safety and Tolerability	through Day 420
Incidence of treatment-emergent adverse events (TEAEs)	Safety and Tolerability	through Day 420
Incidence of adverse events of special interest (AESIs)	Safety and Tolerability	through Day 420

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in UPCR	Efficacy	Multiple timepoints from Day 1 to Day 337
Change in eGFR	Efficacy	Multiple timepoints from Screening to Day 337
Proportion of subjects that are recurrence-free	Efficacy	From Day 1 to Day 337

Collaborators and Investigators

• Sponsor: Tenet Medicines
• Investigators: Study Chair: Keenan, ValenzaBio, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Actual): May 3, 2023
• Study Completion (Actual): October 12, 2023

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Nephrosis; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulosclerosis, Focal Segmental; Nephrosis, Lipoid
• Other Study ID Numbers: 119-02-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No