Clinical Trials

Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for this study-

- Diagnosis of one of the following:

- Primary membranous nephropathy (MN):

- Confirmed by kidney biopsy obtained in the past 5 years, or

- If relapsing following a complete remission or partial remission, confirmed
with a kidney biopsy obtained in the past 7 years

- Nephrotic syndrome, and a contraindication to kidney biopsy (e.g.,
anti-coagulation, solitary kidney, body habitus that increases the risk of
biopsy, or other contraindication in the opinion of the investigator).

- Serum anti-PLA2R positive;

- Estimated Glomerular Filtration Rate (eGFR) ≥ 30 mL/min/1.73m^2 while on maximally
tolerated renin-angiotensin system (RAS) blockade;

- Proteinuria:

- ≥4 and < 8 g/day that has been present for ≥ 3 months while on while on maximally
tolerated RAS blockade, or

- ≥8 g/day while on maximally tolerated RAS blockade.

- Blood pressure while on maximally tolerated RAS blockade:

- Systolic blood pressure ≤ 140 mmHg, and

- Diastolic blood pressure ≤ 90 mmHg

- SARS-CoV-2 vaccination according to the current Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommendations.Completion of a primary vaccination series and at least 1 booster dose against the SARS-CoV-2 virus, as per CDC recommendations for COVID-19 vaccinations. The last COVID-19SARS-CoV-2 vaccine dose must have been administered at least 14 days prior the initiation of the study drug (Visit 0).

Exclusion Criteria:

Subjects meeting any of the following criteria will not be eligible for this study-

-Secondary cause of MN (e.g., SLE, drug, infection, malignancy) suggested by review of the patient’s medical history and/or clinical presentation

Rituximab use within the previous 12 months

Rituximab use > 12 months ago: a. With an undetectable CD19 B cell count, or b. Did not result in a CR (Section 3.3.1) or PR (Section 3.3.2) with rituximab treatment alone (e.g., without other immunosuppressive or immunomodulatory therapy)

Use of anti-B cell therapy other than rituximab within the previous 12 months (or 5 half-lives, whichever is greater)

Cyclophosphamide use within the past 3 months

Use of other immunosuppressive medications such as cyclosporine or tacrolimus within the past 30 days

Use of systemic corticosteroids within the past 30 days

Use of any biologic investigational agent (defined as any drug not approved for sale in the country it is used) in the previous 12 months

Use of any non-biologic investigational agent in the past 30 days (or 5 half-lives, whichever is greater)

Poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) ≥ 9.0%

Patients with diabetic glomerulopathy on renal biopsy that is: a. Greater than Class I diabetic glomerulopathy, or b. Class I diabetic glomerulopathy with a history of poor diabetic control (e.g., HbA1c ≥ 9.0%) since time of biopsy

Unstable kidney function defined as > 1520% decrease in eGFR during the previous 3 months due to primary MN. If the participant has had a > 20% decrease in eGFR in the previous 3 months, as determined by the site investigator in consultation with the protocol chair

Decrease in proteinuria by 50% or more during the previous 12 months

WBC count < 3.0 x 103 /µl

Absolute neutrophil count < 1.5 x 10^3 /µl

Moderately severe anemia (hemoglobin < 9 g/dL)

History of primary immunodeficiency

Serum IgA < 10 mg/dL

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2x the upper limit of normal (ULN)

Positive HIV serology

Positive HCV serology, unless treated with anti-viral therapy with achievement of a sustained virologic response (undetectable viral load 24 weeks after cessation of therapy)

Evidence of current or prior infection with hepatitis B, as indicated by positive HBsAg or positive HBcAb

Positive QuantiFERON – TB Gold test results. PPD tuberculin test may be substituted for QuantiFERON – TB Gold test

History of lung disease with FVC < 70% predicted, DLCO < 70% predicted, or requiring supplemental oxygen

History of malignant neoplasm within the last 5 years except for basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterine cervix treated locally and with no evidence of metastatic disease for 3 years

Absence of individualized, age-appropriate cancer screening

Women of child-bearing potential who are pregnant, nursing, or unwilling to be sexually inactive or use FDA-approved contraception until week 104

Acute or chronic infection, including current use of suppressive therapy for chronic infection, hospitalization for treatment of infection in the past 60 days, or parenteral anti-microbial (including anti-bacterial, anti-viral, or anti-fungal agents) use in the past 60 days for infection

History of an anaphylactic reaction or known sensitivity or intolerance to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies, including rituximab or belimumab

Evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation in the last 2 months, or who in the investigator's judgment, poses a significant suicide risk

Evidence of current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence in the past 12 months

Vaccination with a live vaccine within the past 30 days

Other diseases or conditions or other clinically significant abnormal laboratory value which in the opinion of the investigator would put the patient at risk or confound the results of the study

Inability to comply with study and follow-up procedures

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/8/23. Questions regarding updates should be directed to the study team contact.