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Achieving Complete Remission at Week 104",null,"At Week 104",[14,16,19,21,24,26,28,31,34,36,39,42,45,48,50,52,54],{"measure":15,"description":11,"timeFrame":12},"Percentage of Participants Achieving Complete Remission or Partial Remission at Week 104",{"measure":17,"description":11,"timeFrame":18},"Percentage of Participants Achieving Complete Remission or Partial Remission at Week 78","At Week 78",{"measure":20,"description":11,"timeFrame":18},"Percentage of Participants Achieving Complete Remission at Week 78",{"measure":22,"description":11,"timeFrame":23},"Time to First Complete Remission by Week 104","Up to Week 104",{"measure":25,"description":11,"timeFrame":23},"Time to First Complete Remission or Partial Remission by Week 104",{"measure":27,"description":11,"timeFrame":23},"Duration of Complete Remission in the Inebilizumab Arm",{"measure":29,"description":11,"timeFrame":30},"Percentage Change from Baseline in Anti-Phospholipase A2 Receptor (PLA2R) Antibody Levels in Anti-PLA2R 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(KDQoL)-36 Domain Scores at Week 78 and at Week 104",{"measure":51,"description":11,"timeFrame":41},"Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Score at Week 78 and at Week 104",{"measure":53,"description":11,"timeFrame":41},"Change from baseline in the Estimated Glomerular Filtration Rate (eGFR)",{"measure":55,"description":11,"timeFrame":56},"Percentage of Participants Achieving Stabilized eGFR at week 104, with a Decrease of ≤15 % From Baseline","From Baseline to Week 104",{"allocation":58,"interventionModel":59,"interventionModelDescription":11,"primaryPurpose":60,"observationalModel":11,"timePerspective":11,"maskingInfo":61},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":62,"maskingDescription":11,"whoMasked":11},"NONE",[64,70],{"label":65,"type":66,"description":67,"interventionNames":68},"Inebilizumab","EXPERIMENTAL","Participants will receive inebilizumab via intravenous (IV) infusion",[69],"Drug: Inebilizumab",{"label":71,"type":72,"description":73,"interventionNames":74},"Tacrolimus","ACTIVE_COMPARATOR","Participants will receive tacrolimus orally.",[75],"Drug: Tacrolimus",[77,83],{"type":78,"name":65,"description":79,"armGroupLabels":80,"otherNames":81},"DRUG","Inebilizumab will be administered via IV infusion.",[65],[82],"AMG 335 \u002F Uplizna",{"type":78,"name":71,"description":84,"armGroupLabels":85,"otherNames":11},"Tacrolimus will be administered orally",[71],[87],{"name":88,"affiliation":5,"role":89},"MD","STUDY_DIRECTOR",[91],{"name":92,"role":93,"phone":94,"phoneExt":11,"email":95},"Amgen Call Center","CONTACT","866-572-6436","medinfo@amgen.com",[97,111,121,130],{"facility":98,"status":99,"city":100,"state":101,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":11},"Academic Medical Research Institute","RECRUITING","Los Angeles","California","90022","United 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Pines","33029",{"type":106,"coordinates":135},[136,137],-80.22394,26.00315,{"lat":137,"lon":136},{"type":140,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":153,"type":154},159,"ESTIMATED","INTERVENTIONAL",[157],"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.",[160],"Glomerulonephritis, Membranous",[65,162,163],"AMG 335","Uplizna","2026-09-25",{"date":166,"type":167},"2026-10-01","ACTUAL",{"date":166,"type":154},{"date":170,"type":154},"2033-09-26",{"name":5,"class":6},4]