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
Latest Information Update: 20 Mar 2025
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)