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LNP023 (Iptacopan)

LNP023 is a small-molecule, oral, and selective inhibitor of factor B, a key component of the complement alternative pathway. Lupus nephritis is an immune complex glomerulonephritis and activation of the alternative pathway is thought to occur in lupus nephritis.

Wavy Abstract Background

Enroll in this clinical study

Novartis Pharmaceuticals        

1-888-669-6682

novartis.email@novartis.com

How is LNP023 being studied in lupus nephritis?

The efficacy, safety and tolerability of Iptacopan (LNP023) in addition to standard-of-care treatment with and without oral corticosteroids in patients with active Lupus Nephritis were studied in this randomized, double-blind, dose exploration, parallel group, placebo controlled, multicenter phase 2 trial. The primary outcome is the proportion of patients achieving complete renal response at week 24 in the absence of renal flares.

Eligibility Criteria

Inclusion criteria:

  1. Active biopsy-proven lupus nephritis within 3 months of screening demonstrating Class III or IV lupus nephritis with or without co-existing features of Class V lupus nephritis.

  2. Documentation of active renal disease at the time of screening necessitating the commencement of therapy with corticosteroids in combination with MMF/MPS.

  3. eGFR ≥ 30 ml/min/1.73 m2

  4. First presentation or flare of lupus nephritis

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