NCT05126277

Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

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).

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 462 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	ianalumab s.c. q4w	ianalumab s.c. q4w in addition to SoC
DRUG	ianalumab s.c. q12w	ianalumab s.c. q12w in addition to SoC
DRUG	placebo s.c.	placebo s.c. q4w in addition to SoC

Timeline

• Start date: 2022-07-14
• Primary completion: 2027-06-22
• Completion: 2031-02-11
• First posted: 2021-11-19
• Last updated: 2026-03-18

Locations

188 sites across 27 countries: United States, Argentina, Brazil, Canada, Chile, China, Colombia, Czechia, Estonia, France, Germany, Guatemala, Hong Kong, Hungary, India, Italy, Lithuania, Malaysia, Mexico, Romania, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study