Last Update: Aug 24, 2026 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) ClinicalTrials.gov Identifier: [NCT06711887](https://clinicaltrials.gov/ct2/show/NCT06711887) Novartis Reference Number:CVAY736K12301E1 [See if you Pre-qualify](#trial-eligibility "See if you Pre-qualify") All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. ## Study Description The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety 1\. 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 2\. 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/PRR 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. Investigators 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 In this extension study participants who achieve CRR or PRR status at Week 140 will be withdrawn from study treatment and will maintain the SoC medication as required.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. Condition Lupus Nephritis Phase Phase3 Overall Status Recruiting Number of Participants348 Start Date May 19, 2025 Completion Date Aug 01, 2035 Gender All Age(s) 18 Years - 100 Years (Adult, Older Adult) ## Interventions Drug ### Ianalumab Ianalumab (VAY736) is a human monoclonal antibody (mAb) of the IgG1/κ-class, directed against B cells and binding to BAFF receptor (BAFF-R). ## Eligibility Criteria Inclusion Criteria: 1\. Signed informed consent prior to participation in the extension study. 2\. 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. Exclusion Criteria: 1\. Use of prohibited therapies 2\. Pregnant or nursing (lactating) women. 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