A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multicenter Phase 3 Trial to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Participants With Active Lupus Nephritis (SIRIUS-LN)
This trial will evaluate the efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or ianalumab given every 12 weeks (q12w) compared to placebo, in combination with Standard of Care (SoC), in adult participants with active LN (ISN/RPS class III, IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous), using the 2003 International Society for Nephrology (ISN)/Renal Pathology Society (RPS) criteria).
You may qualify if the following eligibility criteria are met:
- 18 years of age and older
- Have a confirmed clinical diagnosis of SLE
- Have a positive anti-nuclear antibody (ANA) test result
- Active LN at screening, as defined by meeting the 3 following criteria:
- Renal biopsy within 6 months prior to screening period indicating ISN/RPS class III or IV active glomerulonephritis with or without co-existing class V features, or pure class V membranous LN.
- UPCR ≥ 1.0 g/g on 24h urine collection at Screening
- eGFR ≥ 25mL/min/1.73 m2
Toronto Western Hospital is part of the recruitment for this study.