Extension Study Evaluating Long-Term Safety and Effectiveness of Ianalumab With or Without Treatment Withdrawal in Adults With Lupus Nephritis Who Completed the SIRIUS-LN Core Study

What this Trial Is About

This research investigates the long-term efficacy and safety of ianalumab in adults with lupus nephritis who have completed previous treatment in the SIRIUS-LN core study. It evaluates two groups patients who achieved a kidney response and stopped treatment, and those who continue or start open-label ianalumab due to incomplete response or prior open-label treatment. The study aims to understand sustained remission, relapse, and treatment effects over up to six years. Participants are assigned to one of two groups based on their response status at Week 140 of the core study. Those who responded well enter a treatment-withdrawal group and stop study medication while maintaining standard care, with the option to restart ianalumab if kidney flares occur. Others will receive open-label ianalumab 300 mg during the extension. This design allows observation of outcomes both on and off the study drug. During the extension, participants are monitored for kidney flare-ups, need for increased immunosuppressive medications, and safety events including adverse reactions. Blood samples will be collected to measure drug levels and antibodies. The study lasts up to six years, enabling long-term assessment of treatment durability and safety. Participants continue regular assessments and follow-up visits as determined by their clinical status.

Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)