None listed
Conditions
Interventions
secukinumab s.c. (2 PFS × 1,0 ml
de 150 mg de dosis until week 100
Group name:Arm 2 Type of group
placebo s.c. (2 PFS × 1,0 ml de 0
mg de dosis until week 100
Sponsors
Novartis Pharma AG.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of: · SLE with documented history of at least 4 of the 11 criteria for SLE as defined by the American College of Rheumatology (ACR). [NOTE: The 4 criteria do not have to be present at the time of Screening], OR · Lupus nephritis as the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies. 2. Active lupus nephritis, as defined by meeting the 4 following criteria 3. Biopsy within 6 months prior to Screening visit indicating active glomerulonephritis WHO or ISN/RPS Class III or IV LN [excluding III (C), IV-S (C) and IV-G (C)]; subjects are permitted to have co-existing Class V. If no biopsy was performed within 6 months of Screening, a biopsy will need to be performed during the Screening period, after all other inclusion/exclusion criteria would have been verified. · UPCR ≥1 at Screening · Estimated eGFR >30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) ·Active urinary sediment (presence of cellular casts (granular or red blood cell casts) or hematuria (>5 red blood cells per high power field))
Exclusion criteria
Exclusion criteria: 1. Severe renal impairment as defined by i.) Stage 4 CKD, or ii.) presence of oliguria (defined as a documented urine volume < 400 mL/24 hrs), or iii.) ESRD requiring dialysis or transplantation 2. Known intolerance/hypersensitivity to MPA (MMF or enteric-coated MPA sodium), or oral corticosteroids, or any component of the study treatment 3. Subjects having received any other biologic immunomodulatory therapy within 6 months prior to Screening, excluding belimumab where 3 months are acceptable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The measurement will be thought: Estimated glomerular filtration rate (eGFR) within the normal range or no less than 85% of Baseline And 24-hour urine protein-tocreatinine ratio (UPCR) ≤0.5 mg/mg. Measure:Partial Renal Response (PRR) Timepoints:the primary endpoint analysis will be performed at Week 52, there will be a database lock when all subjects have completed Week 52 assessments ; Outcome name:Estimated glomerular filtration rate (eGFR) within the normal range or no less than 85% of Baseline and 24-hour urine protein-to-creatinine ratio (UPCR) ≤0.5 mg/mg Measure:Proportion of subjects achieving CRR (PRR) Timepoints:At week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:It will be determined using one of the following two types of urine collection: .24- hour urine collection Or First morning void urinary sample Measure:Change from baseline related to urine protein-tocreatinine ratio (UPCR) Timepoints:Change from baseline in 24-hour UPCR at Week 52. ; Outcome name:Urine collection, 24-hour urine collection or first morning void urinary sample Measure:Change from Baseline in 24-hour UPCR Timepoints:Week 52 ; Outcome name:≥50% reduction in 24-hour UPCR to sub-nephrotic levels and Normal eGFR or no less than 85% of Baseline Measure:Proportion of subjects achieving PRR Timepoints:Week 52 ; Outcome name:Average daily dose of oral corticosteroids doses will be used to demonstrate superiority of secukinumab Measure:Average daily dose of corticosteroids Timepoints:Week 16 Week 52 ; Outcome name:≥50% reduction in 24-hour UPCR to sub-nephrotic levels and Normal eGFR or no less than 85% of Baseline Measure:Proportion of subjects achieving PRR Timepoints:Week 24 ; Outcome name:Estimated glomerular filtration rate (eGFR) within the normal range or no less than 85% of Baseline and 24-hour urine protein-to-creatinine ratio (UPCR) ≤0.5 mg/mg Measure:Time to achieve CRR Timepoints:Week 52 ; Outcome name:≥50% reduction in 24-hour UPCR to sub-nephrotic levels and Normal eGFR or no less than 85% of Baseline Measure:Time to achieve PRR Timepoints:Week 52 ; Outcome name:RPCO de la primera orina de la mañana ≤0,5 mg/mg Measure:Time to achieve first morning void UPCR Timepoints:Week 52 ; Outcome name:self-reported fatigue and its impact upon daily activities and function over the past week Measure:Improvement in FACIT-Fatigue Timepoints:Week 52 ; Outcome name:self-reported fatigue and its impact upon daily activities and function over the pas | — |
Countries
Argentina, Austria, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Germany, Greece, India, Italy, Japan, Korea South, Norway, Peru, Philippines, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kindgdom, United States, Vietnam
Contacts
Public ContactJacqueline Giron
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed