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

Launched by NOVARTIS PHARMACEUTICALS · Nov 27, 2024

Keywords

ClinConnect Summary

The SIRIUS-LN Extension study is a clinical trial looking to understand how safe and effective a medication called ianalumab is for people with lupus nephritis, a condition that affects the kidneys. This study will last for two years and will include patients who previously participated in another study (the SIRIUS-LN core study). Some patients will continue taking ianalumab, while others who responded well to treatment will stop the medication to see how they do without it. The goal is to gather more information about the treatment's long-term effects.

To join this study, participants must have completed the previous SIRIUS-LN study and given their consent to take part in the extension. The study is open to all adults aged 18 to 75 who are not pregnant or breastfeeding and who have not used certain prohibited therapies. Participants can expect regular check-ins and monitoring of their health over the study period. This trial is an important step in finding better treatments for lupus nephritis and understanding how patients can manage their condition effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed informed consent prior to participation in the extension study.
• • 2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.
• Exclusion Criteria:
• • 1. Use of prohibited therapies
• • 2. Pregnant or nursing (lactating) women.