NCT07851220PHASE3Recruiting
A Phase 3 Study of Inebilizumab in Participants With Primary Membranous Nephropathy
Amgen
Start Date
10/1/2026
Completion Date
9/26/2033
Summary
The primary objective of this study to evaluate the efficacy of inebilizumab on primary membranous nephropathy (PMN) disease activity as measured by complete remission in participants with PMN.
Eligibility Criteria
Age Range: 18 years to 79 years
Inclusion Criteria:
* Adults aged ≥18 years and \<80 years.
* Able and willing to provide written informed consent.
* Primary membranous nephropathy (PMN) confirmed by renal biopsy (performed during screening or within 5 years before screening), or biopsy exemption for participants with anti-PLA2R antibody ≥20 RU/mL at screening.
* Participants with diabetes Hemoglobin A1c (HbA1c) \<7.5% require a renal biopsy report within 2 years before screening (or biopsy during screening) demonstrating PMN without diabetic nephropathy.
* Urine protein-to-creatinine ratio (UPCR) ≥3.5 from a 24-hour urine collection at screening.
* Receiving a maximally tolerated Angiotensin-Converting Enzyme (ACE) inhibitor or (Angiotensin II receptor blocker) ARB for ≥3 months before randomization with adequately controlled blood pressure (\<140/90 mmHg).
Exclusion Criteria:
* Secondary membranous nephropathy (e.g., due to autoimmune disease, infection, malignancy, or medications).
* Estimated glomerular filtration rate (eGFR) \<40 mL/min/1.73 m\^2 , ≥30% decline in eGFR during the previous 24 weeks, need for dialysis, kidney replacement therapy, kidney transplant, or planned transplant during the study.
* Recent thromboembolic event (within 3 months).
* Active HIV, hepatitis B infection, Hepatitis B surface antigen (HBsAg) positive, active hepatitis C infection, uncontrolled diabetes (HbA1c ≥7.5%), active or inadequately treated tuberculosis, recurrent herpes zoster or opportunistic infections, clinically significant active infection, recurrent serious infections, or immunodeficiency disorders.
* Clinically significant laboratory abnormalities, including severe anemia, neutropenia, thrombocytopenia, low Cluster of Differentiation (CD19+) B-cell count, hepatic dysfunction, or immunoglobulin G (IgG) \<400 mg/dL.
* History of solid organ or cell transplantation or progressive multifocal leukoencephalopathy.
* Recent treatment with prohibited therapies, including: B-cell-depleting biologics or other biologic immunomodulators, calcineurin inhibitors, alkylating agents within 3 months;( except history of resistance to calcineurin inhibitors); other immunosuppressive agents within 4 weeks; glucocorticoids within 1 month, or live or live-attenuated vaccines (within 4 weeks before randomization).
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Interventions
DRUG
Inebilizumab
DRUG
Tacrolimus
Conditions
Glomerulonephritis, Membranous
Locations
Academic Medical Research Institute
Los Angeles, California 90022
United States
Bioresearch Partner-Jackson West
Doral, Florida 33122
United States
Bioresearch Partner- Martin Luther King Jr.
Miami, Florida 33127
United States
Bioresearch Partner- Pembroke Pines
Pembroke Pines, Florida 33029
United States