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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ianalumab | Monoclonal antibody | — | Subcutaneous |