drugset / Trial / NCT06133972

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

NCT06133972

Phase 3 Recruiting 550 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).

Timeline

Start
2024-05-21
Primary completion
2030-04-08
Completion
2032-04-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Ianalumab Monoclonal antibody Subcutaneous