Clinical Trial

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

Study acronym: SIRIUS-SLE LTE
Recruiting Phase 3
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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).
Protocol Amendment History 1 change
notable Trial sites expanded: 127 -> 143 locations 2026-07-09
Trial Details
NCT Number NCT06133972
Lead Sponsor Novartis Pharmaceuticals
Conditions Systemic Lupus Erythematosus
Enrollment 550 participants
Start Date 2024-05-21
Primary Completion 2030-04-08 (estimated)
Study Completion 2032-04-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-08