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Ianalumab - SIRIUS LN

Ianalumab is a fully human monoclonal antibody that targets BAFF-Receptor. It has a novel dual mechanism of action: blockade of BAFF-R-mediated signaling and potent depletion of B cells mediated by antibody-dependent cellular cytotoxicity.

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Enroll in this clinical study

Novartis Pharmaceuticals        

1-888-669-6682

novartis.email@novartis.com

How is Ianalumab being studied in Lupus Nephritis?

This is a pivotal double-blind, phase 3, randomized, placebo-controlled, multi-center three-arm study, evaluating at Week 72 efficacy and safety of ianalumab administered s.c. every 4 weeks or ianalumab administered s.c. every 12 weeks versus placebo, administered s.c. every 4 weeks, in adult participants with active LN receiving SoC. In addition, long-term efficacy, safety and tolerability will be collected up to Week 144.


The primary outcome is the frequency and percentage of participants achieving stable complete renal response at 72 weeks.

Eligibility Criteria

  1. Aged 18 years or older

  2. Weigh at least 35 kg at screening

  3. Active Lupus nephritis by renal biopsy within 6 months before the screening period indicating ISN/RPS class III or IV active glomerulonephritis with or without coexisting class V features, or pure class V membranous LN.

  4. UPCR ≥ 1.0 g/g on 24h urine collection at Screening

  5. eGFR ≥ 25mL/min/1.73 m2.

  6. Currently on induction therapy with high-dose corticosteroids and mycophenolate.

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