The purpose of this 2-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.
Signed informed consent prior to participation in the extension study.
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.
Use of prohibited therapies
Pregnant or nursing (lactating) women.
Parallel
Ianalumab
DrugIanalumab (VAY736) is a human monoclonal antibody (mAb) of the IgG1/κ-class, directed against B cells and binding to BAFF receptor (BAFF-R).
For cohort 1: Incidence of renal flare, escalation of immunosuppressive medication, or death
Cohort 1: To estimate the incidence of renal flare, escalation of 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
Cohort 2: Number of participants with Treatment Emergent Adverse Events (TEAE) as assessed by CTAE v4.0
Cohort 2: To assess the safety and tolerability of ianalumab for participants 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
Cohort 2: Number of participants with Serious Adverse Events (SAE) as assessed by CTCAE v4.0
Cohort 2: Incidence of SAEs, from the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study
Cohort 2: Number of participants with clinically significant abnormal vital signs
Cohort 2: Analysis of the vital sign measurements using summary statistics for the change from baseline for each post-baseline visit will be performed
Cohort 1: Number of participants with Treatment Emergent Adverse Events (TEAE) as assessed by CTCAE v4.0
To assess the safety and tolerability of ianalumab in Cohort 1
Cohort 2: Incidence and titer of anti-ianalumab antibodies in serum (ADA assay)
To assess immunogenicity to ianalumab in Cohort 2
Cohort 2: Ianalumab concentration in serum using a validated ELISA
To assess pharmacokinetics of ianalumab in Cohort 2
Cohort 1: Number of participants with Serious Adverse Events (SAE) as assessed by CTAE v4.0
To assess the safety and tolerability of ianalumab in Cohort 1
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