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)
Latest Information Update: 02 Nov 2025
At a glance
- Drugs Ianalumab (Primary)
- Indications Systemic lupus erythematosus
- Focus Registrational; Therapeutic Use
- Acronyms SIRIUS-SLE 1
- Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals
Most Recent Events
- 13 May 2025 Planned primary completion date changed from 19 Jan 2027 to 23 Apr 2027.
- 04 Feb 2025 Planned End Date changed from 16 Jan 2029 to 20 Apr 2029.
- 07 Oct 2024 According to a DelveInsight media release, the company plans to submit for Ianalumab approval by 2027, according to a recent presentation.