[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glomerulonephritis-membranous\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glomerulonephritis-membranous":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100658442","phase-3-a-phase-3-study-of-inebilizumab-in-participants-with-primary-membranous-nephropathy-100658442",false,"NCT07851220","A Phase 3 Study of Inebilizumab in Participants With Primary Membranous Nephropathy","A Phase 3 Randomized, Open-Label Multicenter Study to Evaluate Efficacy and Safety of Inebilizumab in Adult Participants With Primary Membranous Nephropathy (PMN)","MOMENT","Inclusion Criteria:\n\n* Adults aged ≥18 years and \\\u003C80 years.\n* Able and willing to provide written informed consent.\n* 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\u002FmL at screening.\n* Participants with diabetes Hemoglobin A1c (HbA1c) \\\u003C7.5% require a renal biopsy report within 2 years before screening (or biopsy during screening) demonstrating PMN without diabetic nephropathy.\n* Urine protein-to-creatinine ratio (UPCR) ≥3.5 from a 24-hour urine collection at screening.\n* 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 (\\\u003C140\u002F90 mmHg).\n\nExclusion Criteria:\n\n* Secondary membranous nephropathy (e.g., due to autoimmune disease, infection, malignancy, or medications).\n* Estimated glomerular filtration rate (eGFR) \\\u003C40 mL\u002Fmin\u002F1.73 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.\n* Recent thromboembolic event (within 3 months).\n* 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.\n* Clinically significant laboratory abnormalities, including severe anemia, neutropenia, thrombocytopenia, low Cluster of Differentiation (CD19+) B-cell count, hepatic dysfunction, or immunoglobulin G (IgG) \\\u003C400 mg\u002FdL.\n* History of solid organ or cell transplantation or progressive multifocal leukoencephalopathy.\n* 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).\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years","79 Years",{"count":21,"type":22},159,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","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.",[28],"Glomerulonephritis, Membranous",[30,31,32],"Inebilizumab","AMG 335","Uplizna","RECRUITING","2026-09-25",{"date":36,"type":37},"2026-10-01","ACTUAL",{"date":36,"type":22},{"date":40,"type":22},"2033-09-26",{"name":42,"class":43},"Amgen","INDUSTRY",4]