Overview

Efficacy and Safety of VB119 in Subjects With Membranous Nephropathy

Status:
Recruiting
Trial end date:
2023-10-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ValenzaBio, Inc.
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. Has proteinuria with a UPCR ≥3.5 g/g, based on 2 consecutive 24-hour urine 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 <30 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 diabetes mellitus;

7. Has an acute, chronic, or latent infection, including tuberculosis, hepatitis, HIV, or
chronic urinary tract infections;

8. Is positive for SARS-CoV-2 testing at Screening;