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A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

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Trial Profile

A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Sep 2026

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At a glance

  • Drugs Iptacopan (Primary)
  • Indications IgA nephropathy
  • Focus Registrational; Therapeutic Use
  • Acronyms APPLAUSE; APPLAUSE-IgAN
  • Sponsors Novartis; Novartis Pharma A.G.; Novartis Pharmaceuticals

Most Recent Events

  • 17 Jul 2026 Results presented in the Novartis Media Release.
  • 17 Jul 2026 According to a Novartis media release, company announced that the US Food and Drug Administration (FDA) has granted traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression.
  • 10 Jun 2026 New source identified and integrated (Clinical Trials Information System).

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