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).
Novartis Pharmaceuticals
Summary
This trial will evaluate efficacy, safety, and tolerability of subcutaneous (s.c.) ianalumab given every 4 weeks (q4w) or every 12 weeks (q12w) compared to placebo, in combination with SoC, in adult participants with active LN
Description
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 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).
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants eligible for inclusion in this study must meet all of the following criteria: * Adult male and female participants aged 18 years or older at the time of screening * Weigh at least 35 kg at screening * Have a confirmed clinical diagnosis of SLE according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Systemic Lupus Erythematosus (SLE) classification criteria * Have a positive anti-nuclear antibody (ANA) test result; ANA titer ≥ 1:80 at screening visit based on central or local laboratory result * Active LN at screening, as d…
Interventions
- Drugianalumab s.c. q4w
ianalumab s.c. q4w in addition to SoC
- Drugianalumab s.c. q12w
ianalumab s.c. q12w in addition to SoC
- Drugplacebo s.c.
placebo s.c. q4w in addition to SoC
Locations (188)
- University Of AlabamaBirmingham, Alabama
- Advanced Medical ResearchLa Palma, California
- Wallace Rheumatic Study CenterLos Angeles, California
- University of California LALos Angeles, California
- University of California IrvineOrange, California
- School Of MedicineSacramento, California