[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06711887":3,"trial-entities:NCT06711887":355,"trial-summary:NCT06711887":359},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":40,"secondary_outcomes":49,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":67,"locations":70,"central_contacts":340,"overall_officials":346,"references":349,"see_also_links":354},"NCT06711887","CVAY736K12301E1","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)","RECRUITING","2035-08-01","2026-07","2026-07-10","2025-05-19","Novartis Pharmaceuticals","INDUSTRY",true,"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.","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 In this extension study participants who achieve CRR or PRR status at Week 140 will be withdrawn from study treatment and will maintain the SoC medication as required.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.",[19],"Lupus Nephritis",[21,22,23,24],"Lupus Nephritis (LN)","B cell depletion","ianalumab","VAY736","INTERVENTIONAL","TREATMENT",[28],"PHASE3",{"count":30,"type":31},348,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"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).",[38],"Open-Label Ianalumab (cohort 2)",[24],[41,45],{"measure":42,"description":43,"timeFrame":44},"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":46,"description":47,"timeFrame":48},"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",[50,54,57],{"measure":51,"description":52,"timeFrame":53},"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":55,"description":56,"timeFrame":53},"Cohort 2: Ianalumab concentration in serum using a validated ELISA","To assess pharmacokinetics of ianalumab in Cohort 2",{"measure":58,"description":47,"timeFrame":48},"Cohort 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)","ALL","18 Years","100 Years",false,{"inclusion":64,"exclusion":65,"raw_text":66},[],[],"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. 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Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681\u002FASN.0000000772.",[],{"nct_id":4,"conditions":356,"biomarkers":358},[357],"Lupus Glomerulonephritis",[],{"nct_id":4,"found":15,"summary":360,"prompt_version":370},{"design":361,"status":362,"heading":363,"summary":364,"follow_up":365,"word_count":366,"commitments":367,"compensation":368,"drugs_mentioned":369},"This is an open-label extension study, meaning you and your doctors will know if you are receiving ianalumab. It plans to enroll 348 participants.","completed","Extension Study of Ianalumab for Lupus Nephritis","This is an extension study for people who have already participated in the SIRIUS-LN core study for lupus nephritis (a kidney disease caused by lupus). The study is testing ianalumab, a drug that targets certain immune cells (B cells) that contribute to lupus. The main goals are to see how well ianalumab works over a longer period and to monitor any side effects. Some participants who responded well to treatment in the core study will stop taking ianalumab to see if their improvements last, while others will continue with open-label ianalumab. To join, you must have completed the previous SIRIUS-LN core study. The study aims to enroll 348 participants. The current recruitment status is unclear.","Participants will be followed for up to 6 years, with some being monitored for up to 456 weeks (about 8.7 years) for kidney flare-ups or other events, and others for up to 560 weeks (about 10.7 years) for side effects.",115,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]