Lupus Nephritis
Conditions
Keywords
Lupus Nephritis (LN), B cell depletion, ianalumab, VAY736
Brief summary
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.
Detailed description
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 In this extension study participants who achieve CRR or PRR status at Week 140 will be withdrawn from study treatment and will maintain the SoC medication as required.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.
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 |
|---|---|---|
| Cohort 1: Time to renal flare, increase in immunosuppressive medication, or death | Between Week 144E1 and EOS (up to Week 456) | 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 |
| Cohort 2: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study | Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 2: Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) | from Week 144E1 up to Week 456 | To assess immunogenicity to ianalumab in Cohort 2 |
| Cohort 2: Ianalumab concentration in serum using a validated ELISA | from Week 144E1 up to Week 456 | To assess pharmacokinetics of ianalumab in Cohort 2 |
| Cohort 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study | Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs. |
Countries
Brazil, China, Colombia, Czechia, Guatemala, Hong Kong, Hungary, Malaysia, Mexico, Romania, Singapore, South Korea, Spain, Taiwan, Thailand, United States
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed