A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of BIIB023 in subjects with lupus nephritis
|Ages Eligible for Study:||18 Years to 75 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- Documented diagnosis of Systemic Lupus Erythematosus (SLE) according to current American College of Rheumatology (ACR) criteria. At least 4 ACR criteria must be documented, 1 of which must be a positive antinuclear antibody (ANA), anti Sm, or anti dsDNA antibody.
- Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV Lupus Nephritis with either active or active/chronic disease, confirmed by biopsy within 3 months prior to Screening. Subjects are permitted to have co existing Class V Lupus Nephritis. If a renal biopsy has not been performed within 3 months of the Screening Visit, one can be performed during the Screening Period after all other eligibility criteria have been confirmed. The local histological diagnosis must be confirmed by the central study pathologist.
- Must have proteinuria at Screening (from a 24 hour urine sample collection) defined as urinary Protein:Creatinine Ratio (uPCR) >1.0 mg/mg.
- Retinitis, poorly-controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE at Screening
- Estimated GFR <30 mL/min per 1.73 m2 (calculated using the abbreviated MDRD equation) or the presence of oliguria or ESRD requiring dialysis or transplantation
- Subjects requiring dialysis within 12 months prior to Screening
- History of renal transplant
- Treatment with any biologic B-cell-depleting therapy (e.g., anti-CD20 [rituximab], anti-CD22 [epratuzumab], anti-BLyS/BAFF [e.g., briobacept, belimumab] therapy), or TACI-Ig within 12 months prior to Run-in Day 1.