NCT05624749

Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

A Randomized, Double-blind, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 288 (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 ianalumab compared to placebo, given as monthly 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, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 2)

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	ianalumab	ianalumab s.c. monthly
DRUG	placebo	placebo s.c. monthly

Timeline

• Start date: 2023-04-21
• Primary completion: 2027-04-12
• Completion: 2029-04-09
• First posted: 2022-11-22
• Last updated: 2026-03-09

Locations

95 sites across 15 countries: United States, Argentina, Australia, Chile, Colombia, France, Germany, India, Italy, Malaysia, Mexico, Romania, South Korea, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study