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Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis

Comparing Ianalumab and placebo with standard therapy for lupus nephritis.

Recruiting
18 years and older
All
Phase 3

This study tests a new medicine called ianalumab for people with Lupus Nephritis (LN), a kidney disease. Participants will be given the medicine through a small needle under the skin every 4 or 12 weeks. Some will receive a placebo, which is a harmless substance that looks like the medicine but isn't. The study checks if the medicine is safe and how well it works with standard care (SoC), which is the usual treatment for LN.

  • The study lasts for 12 months, with visits every few weeks.
  • Participants must be 18 or older with confirmed lupus and active LN.
  • All participants will receive standard care, and some will receive ianalumab.

Participants must have a positive anti-nuclear antibody test and a kidney biopsy showing specific types of LN. Those with severe kidney problems, recent use of certain drugs, or certain infections can't join. Pregnant or nursing women and those not using effective birth control are excluded. Participants should be able to communicate well with the study team. This study helps to find better treatments for LN, but there are risks, such as side effects from the medicine.

Study details
    Lupus Nephritis

NCT05126277

Novartis Pharmaceuticals

1 April 2025

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