[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570795":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":34,"studyPopulation":27,"armGroups":35,"interventions":46,"overallOfficials":54,"centralContacts":58,"locations":65,"responsibleParty":482,"collaborators":27,"id":484,"slug":485,"hasResults":486,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":490,"eligibilityCriteria":491,"healthyVolunteers":486,"sex":492,"minAge":493,"maxAge":494,"enrollmentInfo":495,"targetDuration":27,"studyType":498,"phases":499,"briefSummary":501,"conditions":502,"keywords":504,"overallStatus":68,"whyStopped":27,"lastUpdateSubmitDate":508,"lastUpdatePostDateStruct":509,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":517},{"fullName":5,"class":6},"Novartis","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":27},[9,13],{"measure":10,"description":11,"timeFrame":12},"Cohort 1: Time to renal flare, increase in immunosuppressive medication, or death","Cohort 1: To estimate the time to renal flare, increase in immunosuppressive medication, or death following study treatment withdrawal in participants who completed the SIRIUS-LN core study on double-blind treatment and achieved CRR or PRR at Week 140 of the core study","Between Week 144E1 and EOS (up to Week 456)",{"measure":14,"description":15,"timeFrame":16},"Cohort 2: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)","Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs.","From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study",[18,22,25],{"measure":19,"description":20,"timeFrame":21},"Cohort 2: Incidence and titer of anti-ianalumab antibodies in serum (ADA assay)","To assess immunogenicity to ianalumab in Cohort 2","from Week 144E1 up to Week 456",{"measure":23,"description":24,"timeFrame":21},"Cohort 2: Ianalumab concentration in serum using a validated ELISA","To assess pharmacokinetics of ianalumab in Cohort 2",{"measure":26,"description":15,"timeFrame":16},"Cohort 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":33,"maskingDescription":27,"whoMasked":27},"NONE","The SIRIUS-LN extension study is an up to 6-year open-label extension study for participants who have completed the treatment periods (blinded Treatment Period-1 and blinded Treatment Period-2) of the SIRIUS-LN core study on double-blind or open-label study treatment.\n\nInvestigators will use their clinical judgment to decide if it is beneficial for participants to continue with the extension study. In this extension study participants who achieve CRR or PRR status at Week 140 will be withdrawn from study treatment and will maintain the SoC medication as required. These up to 6 additional years in the extension study will allow to measure sustained remission, flares and safety off-study treatment. However, in the event of renal flares during the extension study, these participants who withdraw study treatment will have the option to receive open-label ianalumab.",[36,40],{"label":37,"type":38,"description":39,"interventionNames":27},"Study Treatment Withdrawal (cohort 1)","NO_INTERVENTION","(Cohort 1): Study Treatment-Withdrawal group. Participants who received blinded study treatment in the core study and achieve CRR or PRR at Week 140 in the core study will enter the extension study and discontinue study treatment while maintaining standard of care (SoC) medication, as required. If renal flare criteria are met, participants will be eligible to receive open-label ianalumab.",{"label":41,"type":42,"description":43,"interventionNames":44},"Open-Label Ianalumab (cohort 2)","EXPERIMENTAL","(Cohort 2): Open-Label Ianalumab group: Participants who received blinded study treatment throughout the core study and did not achieve CRR or PRR at Week 140 of the core study, or who had switched to open-label ianalumab during the core study, will be eligible or will continue to receive open-label ianalumab in the extension study.",[45],"Drug: Ianalumab",[47],{"type":48,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"DRUG","Ianalumab","Ianalumab (VAY736) is a human monoclonal antibody (mAb) of the IgG1\u002Fκ-class, directed against B cells and binding to BAFF receptor (BAFF-R).",[41],[53],"VAY736",[55],{"name":56,"affiliation":56,"role":57},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[59,63],{"name":56,"role":60,"phone":61,"phoneExt":27,"email":62},"CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":56,"role":60,"phone":64,"phoneExt":27,"email":62},"+41613241111",[66,87,99,108,117,126,135,146,155,163,172,181,190,199,207,215,220,225,233,244,253,261,271,282,291,296,306,316,326,335,346,354,362,372,381,386,396,404,409,414,424,434,445,453,458,463,471],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Circuit Clinical","RECRUITING","Orchard Park","New York","14127","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-78.74392,42.76756,{"lat":78,"lon":77},[81,84],{"name":82,"role":60,"phone":27,"phoneExt":27,"email":83},"Gabriella Demelo","gdemelo@circuitclinical.com",{"name":85,"role":86,"phone":27,"phoneExt":27,"email":27},"Isha Gupta","PRINCIPAL_INVESTIGATOR",{"facility":88,"status":68,"city":89,"state":90,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":98,"contacts":27},"Novartis Investigative Site","Vitória","Espírito Santo","29055-450","Brazil","BR",{"type":75,"coordinates":95},[96,97],-40.33778,-20.31944,{"lat":97,"lon":96},{"facility":88,"status":68,"city":100,"state":101,"zip":102,"country":92,"countryCode":93,"cosmosGeoPoint":103,"geoPoint":107,"contacts":27},"Salvador","Estado de Bahia","40150-150",{"type":75,"coordinates":104},[105,106],-38.49096,-12.97563,{"lat":106,"lon":105},{"facility":88,"status":68,"city":109,"state":110,"zip":111,"country":92,"countryCode":93,"cosmosGeoPoint":112,"geoPoint":116,"contacts":27},"Belo Horizonte","Minas Gerais","30150-221",{"type":75,"coordinates":113},[114,115],-43.93778,-19.92083,{"lat":115,"lon":114},{"facility":88,"status":68,"city":118,"state":119,"zip":120,"country":92,"countryCode":93,"cosmosGeoPoint":121,"geoPoint":125,"contacts":27},"Recife","Pernambuco","50740-900",{"type":75,"coordinates":122},[123,124],-34.88111,-8.05389,{"lat":124,"lon":123},{"facility":88,"status":68,"city":127,"state":128,"zip":129,"country":92,"countryCode":93,"cosmosGeoPoint":130,"geoPoint":134,"contacts":27},"Santo André","São Paulo","09090-790",{"type":75,"coordinates":131},[132,133],-46.53833,-23.66389,{"lat":133,"lon":132},{"facility":88,"status":68,"city":136,"state":137,"zip":138,"country":139,"countryCode":140,"cosmosGeoPoint":141,"geoPoint":145,"contacts":27},"Guangzhou","Guangdong","510000","China","CN",{"type":75,"coordinates":142},[143,144],113.25,23.11667,{"lat":144,"lon":143},{"facility":88,"status":147,"city":148,"state":137,"zip":149,"country":139,"countryCode":140,"cosmosGeoPoint":150,"geoPoint":154,"contacts":27},"ACTIVE_NOT_RECRUITING","Shantou","515000",{"type":75,"coordinates":151},[152,153],116.67876,23.35489,{"lat":153,"lon":152},{"facility":88,"status":68,"city":156,"state":137,"zip":157,"country":139,"countryCode":140,"cosmosGeoPoint":158,"geoPoint":162,"contacts":27},"Shenzhen","518037",{"type":75,"coordinates":159},[160,161],114.0683,22.54554,{"lat":161,"lon":160},{"facility":88,"status":68,"city":164,"state":165,"zip":166,"country":139,"countryCode":140,"cosmosGeoPoint":167,"geoPoint":171,"contacts":27},"Liuzhou","Guangxi","545005",{"type":75,"coordinates":168},[169,170],109.40698,24.32405,{"lat":170,"lon":169},{"facility":88,"status":68,"city":173,"state":174,"zip":175,"country":139,"countryCode":140,"cosmosGeoPoint":176,"geoPoint":180,"contacts":27},"Wuhan","Hubei","430060",{"type":75,"coordinates":177},[178,179],114.26667,30.58333,{"lat":179,"lon":178},{"facility":88,"status":68,"city":182,"state":183,"zip":184,"country":139,"countryCode":140,"cosmosGeoPoint":185,"geoPoint":189,"contacts":27},"Changchun","Jilin","130041",{"type":75,"coordinates":186},[187,188],125.32278,43.88,{"lat":188,"lon":187},{"facility":88,"status":68,"city":191,"state":192,"zip":193,"country":139,"countryCode":140,"cosmosGeoPoint":194,"geoPoint":198,"contacts":27},"Binzhou","Shandong","256603",{"type":75,"coordinates":195},[196,197],118.01667,37.36667,{"lat":197,"lon":196},{"facility":88,"status":68,"city":200,"state":27,"zip":201,"country":139,"countryCode":140,"cosmosGeoPoint":202,"geoPoint":206,"contacts":27},"Beijing","100034",{"type":75,"coordinates":203},[204,205],116.39723,39.9075,{"lat":205,"lon":204},{"facility":88,"status":68,"city":208,"state":27,"zip":209,"country":139,"countryCode":140,"cosmosGeoPoint":210,"geoPoint":214,"contacts":27},"Chongqing","400038",{"type":75,"coordinates":211},[212,213],106.55771,29.56026,{"lat":213,"lon":212},{"facility":88,"status":68,"city":136,"state":27,"zip":216,"country":139,"countryCode":140,"cosmosGeoPoint":217,"geoPoint":219,"contacts":27},"510080",{"type":75,"coordinates":218},[143,144],{"lat":144,"lon":143},{"facility":88,"status":68,"city":136,"state":27,"zip":221,"country":139,"countryCode":140,"cosmosGeoPoint":222,"geoPoint":224,"contacts":27},"510280",{"type":75,"coordinates":223},[143,144],{"lat":144,"lon":143},{"facility":88,"status":68,"city":226,"state":27,"zip":227,"country":139,"countryCode":140,"cosmosGeoPoint":228,"geoPoint":232,"contacts":27},"Shanghai","200080",{"type":75,"coordinates":229},[230,231],121.45806,31.22222,{"lat":231,"lon":230},{"facility":88,"status":68,"city":234,"state":235,"zip":236,"country":237,"countryCode":238,"cosmosGeoPoint":239,"geoPoint":243,"contacts":27},"Barranquilla","Atlántico","080020","Colombia","CO",{"type":75,"coordinates":240},[241,242],-74.78132,10.96854,{"lat":242,"lon":241},{"facility":88,"status":147,"city":245,"state":27,"zip":246,"country":247,"countryCode":27,"cosmosGeoPoint":248,"geoPoint":252,"contacts":27},"Olomouc","779 00","Czechia",{"type":75,"coordinates":249},[250,251],17.25175,49.59552,{"lat":251,"lon":250},{"facility":88,"status":68,"city":254,"state":27,"zip":255,"country":247,"countryCode":27,"cosmosGeoPoint":256,"geoPoint":260,"contacts":27},"Prague","128 00",{"type":75,"coordinates":257},[258,259],14.42076,50.08804,{"lat":259,"lon":258},{"facility":88,"status":68,"city":262,"state":27,"zip":263,"country":264,"countryCode":265,"cosmosGeoPoint":266,"geoPoint":270,"contacts":27},"Grenoble","38043","France","FR",{"type":75,"coordinates":267},[268,269],5.71479,45.17869,{"lat":269,"lon":268},{"facility":88,"status":68,"city":272,"state":273,"zip":274,"country":275,"countryCode":276,"cosmosGeoPoint":277,"geoPoint":281,"contacts":27},"Guatemala City","Departamento de Guatemala","01011","Guatemala","GT",{"type":75,"coordinates":278},[279,280],-90.51327,14.64072,{"lat":280,"lon":279},{"facility":88,"status":68,"city":283,"state":284,"zip":285,"country":275,"countryCode":276,"cosmosGeoPoint":286,"geoPoint":290,"contacts":27},"Quetzaltenango","Departamento de Quetzaltenango","09001",{"type":75,"coordinates":287},[288,289],-91.52316,14.84462,{"lat":289,"lon":288},{"facility":88,"status":68,"city":272,"state":27,"zip":292,"country":275,"countryCode":276,"cosmosGeoPoint":293,"geoPoint":295,"contacts":27},"01010",{"type":75,"coordinates":294},[279,280],{"lat":280,"lon":279},{"facility":88,"status":68,"city":297,"state":27,"zip":298,"country":299,"countryCode":300,"cosmosGeoPoint":301,"geoPoint":305,"contacts":27},"Tuenmen","999077","Hong Kong","HK",{"type":75,"coordinates":302},[303,304],113.97157,22.39175,{"lat":304,"lon":303},{"facility":88,"status":68,"city":307,"state":27,"zip":308,"country":309,"countryCode":310,"cosmosGeoPoint":311,"geoPoint":315,"contacts":27},"Budapest","1097","Hungary","HU",{"type":75,"coordinates":312},[313,314],19.04045,47.49835,{"lat":314,"lon":313},{"facility":88,"status":68,"city":317,"state":317,"zip":318,"country":319,"countryCode":320,"cosmosGeoPoint":321,"geoPoint":325,"contacts":27},"Kuala Lumpur","50586","Malaysia","MY",{"type":75,"coordinates":322},[323,324],101.68653,3.1412,{"lat":324,"lon":323},{"facility":88,"status":68,"city":327,"state":328,"zip":329,"country":319,"countryCode":320,"cosmosGeoPoint":330,"geoPoint":334,"contacts":27},"Sibu","Sarawak","96000",{"type":75,"coordinates":331},[332,333],111.81667,2.3,{"lat":333,"lon":332},{"facility":88,"status":68,"city":336,"state":337,"zip":338,"country":339,"countryCode":340,"cosmosGeoPoint":341,"geoPoint":345,"contacts":27},"León","Guanajuato","37160","Mexico","MX",{"type":75,"coordinates":342},[343,344],-101.68253,21.12183,{"lat":344,"lon":343},{"facility":88,"status":68,"city":347,"state":27,"zip":348,"country":339,"countryCode":340,"cosmosGeoPoint":349,"geoPoint":353,"contacts":27},"Oaxaca City","68020",{"type":75,"coordinates":350},[351,352],-96.72544,17.06025,{"lat":352,"lon":351},{"facility":88,"status":68,"city":355,"state":27,"zip":356,"country":339,"countryCode":340,"cosmosGeoPoint":357,"geoPoint":361,"contacts":27},"Querétaro","76070",{"type":75,"coordinates":358},[359,360],-92.75774,15.83752,{"lat":360,"lon":359},{"facility":88,"status":68,"city":363,"state":27,"zip":364,"country":365,"countryCode":366,"cosmosGeoPoint":367,"geoPoint":371,"contacts":27},"Bucharest","022328","Romania","RO",{"type":75,"coordinates":368},[369,370],26.10626,44.43225,{"lat":370,"lon":369},{"facility":88,"status":68,"city":373,"state":373,"zip":374,"country":373,"countryCode":375,"cosmosGeoPoint":376,"geoPoint":380,"contacts":27},"Singapore","308433","SG",{"type":75,"coordinates":377},[378,379],103.85007,1.28967,{"lat":379,"lon":378},{"facility":88,"status":68,"city":373,"state":27,"zip":382,"country":373,"countryCode":375,"cosmosGeoPoint":383,"geoPoint":385,"contacts":27},"169608",{"type":75,"coordinates":384},[378,379],{"lat":379,"lon":378},{"facility":88,"status":68,"city":387,"state":388,"zip":389,"country":390,"countryCode":27,"cosmosGeoPoint":391,"geoPoint":395,"contacts":27},"Suwon","Gyeonggi-do","16499","South Korea",{"type":75,"coordinates":392},[393,394],127.00889,37.29111,{"lat":394,"lon":393},{"facility":88,"status":68,"city":397,"state":27,"zip":398,"country":390,"countryCode":27,"cosmosGeoPoint":399,"geoPoint":403,"contacts":27},"Seoul","03722",{"type":75,"coordinates":400},[401,402],126.9784,37.566,{"lat":402,"lon":401},{"facility":88,"status":68,"city":397,"state":27,"zip":405,"country":390,"countryCode":27,"cosmosGeoPoint":406,"geoPoint":408,"contacts":27},"04763",{"type":75,"coordinates":407},[401,402],{"lat":402,"lon":401},{"facility":88,"status":68,"city":397,"state":27,"zip":410,"country":390,"countryCode":27,"cosmosGeoPoint":411,"geoPoint":413,"contacts":27},"06591",{"type":75,"coordinates":412},[401,402],{"lat":402,"lon":401},{"facility":88,"status":68,"city":415,"state":27,"zip":416,"country":417,"countryCode":418,"cosmosGeoPoint":419,"geoPoint":423,"contacts":27},"Barcelona","08035","Spain","ES",{"type":75,"coordinates":420},[421,422],2.15899,41.38879,{"lat":422,"lon":421},{"facility":88,"status":68,"city":425,"state":27,"zip":426,"country":427,"countryCode":428,"cosmosGeoPoint":429,"geoPoint":433,"contacts":27},"Taichung","40447","Taiwan","TW",{"type":75,"coordinates":430},[431,432],120.6839,24.1469,{"lat":432,"lon":431},{"facility":88,"status":68,"city":435,"state":436,"zip":437,"country":438,"countryCode":439,"cosmosGeoPoint":440,"geoPoint":444,"contacts":27},"Songkhla","Hat Yai","90110","Thailand","TH",{"type":75,"coordinates":441},[442,443],100.5951,7.19882,{"lat":443,"lon":442},{"facility":88,"status":68,"city":446,"state":27,"zip":447,"country":438,"countryCode":439,"cosmosGeoPoint":448,"geoPoint":452,"contacts":27},"Bangkok","10330",{"type":75,"coordinates":449},[450,451],100.50144,13.75398,{"lat":451,"lon":450},{"facility":88,"status":68,"city":446,"state":27,"zip":454,"country":438,"countryCode":439,"cosmosGeoPoint":455,"geoPoint":457,"contacts":27},"10400",{"type":75,"coordinates":456},[450,451],{"lat":451,"lon":450},{"facility":88,"status":68,"city":446,"state":27,"zip":459,"country":438,"countryCode":439,"cosmosGeoPoint":460,"geoPoint":462,"contacts":27},"10700",{"type":75,"coordinates":461},[450,451],{"lat":451,"lon":450},{"facility":88,"status":68,"city":464,"state":27,"zip":465,"country":438,"countryCode":439,"cosmosGeoPoint":466,"geoPoint":470,"contacts":27},"Chiang Mai","50200",{"type":75,"coordinates":467},[468,469],98.98468,18.79038,{"lat":469,"lon":468},{"facility":88,"status":68,"city":472,"state":473,"zip":474,"country":475,"countryCode":476,"cosmosGeoPoint":477,"geoPoint":481,"contacts":27},"Ho Chi Minh City","VNM","700000","Vietnam","VN",{"type":75,"coordinates":478},[479,480],106.62965,10.82302,{"lat":480,"lon":479},{"type":483,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100570795","phase-3-phase-iii-extension-study-of-efficacy-and-safety-of-ianalumab-with-or-without-study-treatment-withdrawal-in-participants-with-lupus-nephritis-sirius-ln-extension-100570795",false,"NCT06711887","Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)","An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)","SIRIUS-LN ext","Inclusion Criteria:\n\n1. Signed informed consent prior to participation in the extension study.\n2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.\n\nExclusion Criteria:\n\n1. Use of prohibited therapies\n2. Pregnant or nursing (lactating) women.","ALL","18 Years","100 Years",{"count":496,"type":497},348,"ESTIMATED","INTERVENTIONAL",[500],"PHASE3","The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety\n\n1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \\[CRR\\] or partial renal response \\[PRR\\]) on double-blind treatment at the end of the SIRIUS-LN core study, and\n2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR\u002FPRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.",[503],"Lupus Nephritis",[505,506,507,53],"Lupus Nephritis (LN)","B cell depletion","ianalumab","2026-08-21",{"date":510,"type":511},"2026-08-24","ACTUAL",{"date":513,"type":511},"2025-05-19",{"date":515,"type":497},"2035-08-01",{"name":56,"class":6},47]