Lupus Nephritis
Conditions
Sponsors
Novartis Pharma. K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Adult male and female subjects aged 18 - 75 years old at the time of Baseline. 2.Confirmed diagnosis of: - SLE as defined by the American College of Rheumatology (ACR), OR - LN as the sole clinical criterion in the presence of ANA or anti-dsDNA antibodies. 3.Active lupus nephritis: - International Society of Neurology/Renal Pathology Society (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. - UPCR =>1 at Screening. - Estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73 m2. - Active urinary sediment. Other inclusion criteria may apply.
Exclusion criteria
Exclusion criteria: 1.Severe renal impairment and subjects requiring dialysis dialysis within the previous 12 months before Screening. 2.Significant medical Problems like myocarditis, pericarditis, severe manifestations of neuropsychiatric SLE (NPSLE). 3.Cyclophosphamide (CYC) use (i.v. or oral) within the month prior to baseline. More than 3000 mg i.v. pulse methylprednisolone (cumulative dose) use within 12 weeks prior to Baseline. 4.Active ongoing inflammatory diseases. 5.Previous exposure to secukinumab (AIN457) or any other biologic drug targeting IL-17 or the IL-17 receptor. 6.Ongoing infections or malignant process. 7.Pregnant or lactating women. Other exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Proportion of subjects achieving Complete Renal Response (CRR) [ Time Frame: Week 52 ] Proportion of subjects achieving protocol-defined CRR | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Change in 24-hour Urine Protein-to Creatinine Ratio (UPCR) [ Time Frame: Week 52 ] Change from Baseline in 24-hour UPCR efficacy Proportion of subjects achieving Partial Renal Response (PRR) [ Time Frame: Week 52 ] Proportion of subjects achieving protocol-defined PRR efficacy Average daily dose of oral corticosteroids [ Time Frame: Week 16 to Week 52 ] Average daily dose of oral corticosteroids compared to placebo efficacy Proportion of subjects achieving PRR [ Time Frame: Week 24 ] Proportion of subjects achieving PRR efficacy Time to achieve CRR [ Time Frame: Baseline to Week 52 ] Time to achieve CRR efficacy Time to achieve PRR [ Time Frame: Baseline to Week 52 ] Time to achieve PRR efficacy Time to achieve UPCR <= 0.5 mg/mg [ Time Frame: Baseline to Week 52 ] Time to achieve first morning void UPCR <= 0.5 mg/mg efficacy Improvement in FACIT-Fatigue [ Time Frame: Baseline to Week 52 ] Improvement in FACIT-Fatigue mean change of score compared to placebo efficacy Improvement in SF-36 PCS mean [ Time Frame: Baseline to Week 52 ] Improvement in SF-36 PCS mean change compared to placebo efficacy Improvement in LupusQoL Physical Health mean [ Time Frame: Baseline to Week 52 ] Improvement in LupusQoL Physical Health mean change of score compared to placebo safety Incidence of Treatment-emergent AEs (TEAEs) / SAEs [ Time Frame: Baseline to Week 52 ] Incidence of Treatment-emergent AEs (TEAEs) / SAEs from Baseline to Week 52; vital signs and body measurements, standard chemistry and hematology efficacy Proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52 [ Time Frame: Week 52 to Week 104 ] Estimate the proportion of subjects with CRR at Week 104 within subjects who had achieved CRR at Week 52 in the secukinumab group efficacy Proportion of subjects with improved or maintained renal response at Week 104 [ Time Frame: Week 52 to Week 104 ] Estimate the proportion of subjects with improved or maintained response (PRR or CRR) | — |
Countries
Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America
Contacts
Public ContactHiroyuki Yamada
Novartis Pharma. K.K.
Outcome results
None listed