NCT06133972

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

A Randomized, Double-blind, Placebo-controlled Extension Study to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 550 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).

Detailed description

The purpose of this extension study is to evaluate long-term safety and tolerability of ianalumab administered s.c. monthly or quarterly, compared to monthly placebo, in adolescent and adult participants with anti-nuclear antibody (ANA)-positive systemic lupus erythematosus of moderate-to-severe disease activity, who have completed either CVAY736F12301 (SIRIUS-SLE 1) or CVAY736F12302 (SIRIUS-SLE 2) core studies.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Placebo	Placebo s.c. monthly
DRUG	Ianalumab	Ianalumab s.c. monthly Ianalumab s.c. quarterly

Timeline

• Start date: 2024-05-21
• Primary completion: 2030-04-08
• Completion: 2032-04-05
• First posted: 2023-11-18
• Last updated: 2026-03-13

Locations

127 sites across 28 countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, France, Germany, Guatemala, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Poland, Portugal, Romania, South Africa, South Korea, Spain, Taiwan, Thailand

Regulatory

• FDA-regulated drug study