Lupus Nephritis
Conditions
Keywords
Lupus Nephritis (LN), B cell depletion, ianalumab, VAY736
Brief summary
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.
Detailed description
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 In this extension study participants who achieve CRR or PRR status at Week 140 will be withdrawn from study treatment and will maintain the SoC medication as required.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.
Interventions
DRUGIanalumab
Ianalumab (VAY736) is a human monoclonal antibody (mAb) of the IgG1/κ-class, directed against B cells and binding to BAFF receptor (BAFF-R).
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| For cohort 1: Incidence of renal flare, escalation of immunosuppressive medication, or death | Between Week 144E1 and Week 248 | 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 | From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study | 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 | From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study | 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 | From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study | 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 2: Number of participants with clinically significant laboratory evaluations. | From the start of treatment in the SIRIUS-LN core study to EOS (up to week 352) of the extension study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Number of participants with Treatment Emergent Adverse Events (TEAE) as assessed by CTCAE v4.0 | From the start of treatment in the SIRIUS-LN core study up to EOS (week 248) of the extension study | To assess the safety and tolerability of ianalumab in Cohort 1 |
| Cohort 2: Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) | from Week 144E1 up to Week 248 | To assess immunogenicity to ianalumab in Cohort 2 |
| Cohort 2: Ianalumab concentration in serum using a validated ELISA | from Week 144E1 up to Week 248 | To assess pharmacokinetics of ianalumab in Cohort 2 |
| Cohort 1: Number of participants with Serious Adverse Events (SAE) as assessed by CTAE v4.0 | From the start of treatment in the SIRIUS-LN core study up to EOS (week 248) of the extension study | To assess the safety and tolerability of ianalumab in Cohort 1 |
| Cohort 1: Number of participants with clinically significant abnormal vital signs | From the start of treatment in the SIRIUS-LN core study up to EOS (week 248) of the extension study | To assess the safety and tolerability of ianalumab in Cohort 1 |
| Cohort 1: Number of participants with clinically significant abnormal laboratory evaluations | From the start of treatment in the SIRIUS-LN core study up to EOS (week 248) of the extension study | To assess the safety and tolerability of ianalumab in Cohort 1 |
Countries
Brazil, China, Colombia, Hungary, Mexico, Romania, Singapore, South Korea, Taiwan, Thailand
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed