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.
The SIRIUS-LN extension study is a 2-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 In this extension study participants who achieve CRR or PRR status at Week 140 will be withdrawn from study treatment and will maintain the SoC medication as required.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 2 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
315
Ianalumab (VAY736) is a human monoclonal antibody (mAb) of the IgG1/κ-class, directed against B cells and binding to BAFF receptor (BAFF-R).
Novartis Investigative Site
Liuchow, Guangxi, China
RECRUITINGNovartis Investigative Site
Wuhan, Hubei, China
RECRUITINGNovartis Investigative Site
Binzhou, Shandong, China
RECRUITINGNovartis Investigative Site
Beijing, China
RECRUITINGNovartis Investigative Site
Guangzhou, China
RECRUITINGNovartis Investigative Site
Guangzhou, China
RECRUITINGNovartis Investigative Site
Barranquilla, Atlántico, Colombia
RECRUITINGNovartis Investigative Site
Budapest, Hungary
RECRUITINGNovartis Investigative Site
León, Guanajuato, Mexico
RECRUITINGNovartis Investigative Site
Oaxaca City, Mexico
RECRUITING...and 11 more locations
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
Time frame: Between Week 144E1 and Week 248
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
Time frame: 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 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
Time frame: 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
Time frame: 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 laboratory evaluations.
Cohort 2: The summary of laboratory evaluations will be presented for two groups of laboratory tests (hematology and serum chemistry). Descriptive summary statistics for the change from baseline to each study visit will be presented. These descriptive summaries will be presented by test group, laboratory test and treatment group.
Time frame: From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study
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
Time frame: From the start of treatment in the SIRIUS-LN core study up to EOS (week 248) of the extension study
Cohort 2: Incidence and titer of anti-ianalumab antibodies in serum (ADA assay)
To assess immunogenicity to ianalumab in Cohort 2
Time frame: from Week 144E1 up to Week 248
Cohort 2: Ianalumab concentration in serum using a validated ELISA
To assess pharmacokinetics of ianalumab in Cohort 2
Time frame: from Week 144E1 up to Week 248
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
Time frame: From the start of treatment in the SIRIUS-LN core study up to EOS (week 248) of the extension study
Cohort 1: Number of participants with clinically significant abnormal vital signs
To assess the safety and tolerability of ianalumab in Cohort 1
Time frame: From the start of treatment in the SIRIUS-LN core study up to EOS (week 248) of the extension study
Cohort 1: Number of participants with clinically significant abnormal laboratory evaluations
To assess the safety and tolerability of ianalumab in Cohort 1
Time frame: From the start of treatment in the SIRIUS-LN core study up to EOS (week 248) of the extension study
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