STUDY OF SAFETY, EFFICACY AND TOLERABILITY OFSECUKINUMAB VERSUS PLACEBO, IN COMBINATION WITH SOCTHERAPY, IN PATIENTS WITH ACTIVE LUPUS NEPHRITIS

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The measurement will be thought: Estimated<br>glomerular filtration rate (eGFR) within the<br>normal range or no less than 85% of Baseline And 24-hour urine protein-tocreatinine ratio<br>(UPCR) ≤0.5 mg/mg.<br>Measure:Partial Renal<br>Response (PRR)<br>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<br>;<br>Outcome name:Estimated glomerular filtration rate (eGFR) within the normal range or no less than 85% of Baseline<br>and<br>24-hour urine protein-to-creatinine ratio (UPCR) ≤0.5 mg/mg<br><br>Measure:Proportion of subjects achieving CRR (PRR)<br>Timepoints:At week 52<br>

Secondary Outcome Measures