NCT05639114

Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)

A Randomized, Double-blind, Parallel Group, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 436 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The trial will evaluate efficacy, safety and tolerability of two regimens of ianalumab compared to placebo, given as monthly or quarterly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).

Detailed description

A randomized, double-blind, parallel group, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of two regimens of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 1)

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Ianalumab	ianalumab s.c. monthly or quarterly
DRUG	Placebo	placebo s.c. monthly

Timeline

• Start date: 2023-03-02
• Primary completion: 2027-03-24
• Completion: 2029-03-21
• First posted: 2022-12-06
• Last updated: 2026-03-09

Locations

135 sites across 19 countries: United States, Argentina, Brazil, Bulgaria, Canada, China, Colombia, Czechia, Guatemala, Hungary, Israel, Japan, Poland, Portugal, Slovakia, South Africa, Spain, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study