Home › Membranous Glomerulonephritis › NCT07851220
A Phase 3 Study of Inebilizumab in Participants With Primary Membranous Nephropathy
RecruitingPhase 3
A Phase 3 Randomized, Open-Label Multicenter Study to Evaluate Efficacy and Safety of Inebilizumab in Adult Participants With Primary Membranous Nephropathy (PMN)
Who can join
Ages 18 to 79 · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- Inebilizumab (drug)
- Tacrolimus (drug)
Sponsor: Amgen · Participants: 159 · Started: Oct 1, 2026
Contact the study team
- Amgen Call Center · Phone: 866-572-6436
Official record on ClinicalTrials.gov — NCT07851220
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.