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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

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: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Mar 2025

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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 Mar 2025 Planned End Date changed from 15 Oct 2025 to 2 Oct 2025.
  • 17 Mar 2025 Planned primary completion date changed from 15 Oct 2025 to 2 Oct 2025.
  • 08 Aug 2024 According to a Novartis media release, the company receives FDA accelerated approval for Fabhalta (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN)

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