drugset / Trial / 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)

NCT05639114

Phase 3 Active not recruiting 436 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2023-03-02
Primary completion
2027-03-24
Completion
2029-03-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Ianalumab Monoclonal antibody Subcutaneous