IPTACOPAN:
APPLAUSE-IgAN
Local activation of the alternative complement pathway (AP) in the mesangium influences the extent of glomerular injury in IgA nephropathy. Iptacopan (LNP023) is a potent oral highly selective inhibitor of factor B of alternative complement pathway.
Enroll in this clinical study
How is Iptacopan being studied in IgAN?
A phase 2 RCT showed Iptacopan was well tolerated and led to reduction in proteinuria and strong inhibition of AP activity through 6 months in patients with IgAN. Based on these results a phase 3 RCT- APPLAUSE-IgAN has been designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of LNP023 at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.
The trial will enroll approximately 450 participants; 430 biopsy-proven IgAN participants with eGFR ≥30 mL /min/1.73m2 (main study population) and approximately 20 participants with eGFR 20 to <30 mL/min/1.73m2. The trial will consist of a run in period for 3 months and a treatment period of 24 months
Update:
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Study met its pre-specified interim analysis primary endpoint, demonstrating superiority of iptacopan vs placebo in proteinuria reduction. The study continues in a double-blind fashion to evaluate iptacopan’s ability to slow IgAN progression by measuring estimated glomerular filtration rate (eGFR) slope over 24 months – the primary endpoint at the study end with topline results expected in 2025. Novartis announced that it is eyeing an FDA application for accelerated approval in 2024.
Eligibility Criteria
01
vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections
03
Vaccination against Neisseria meningitidis infection
05
Stable maximally tolerated doses of ACEi or ARB
02
Proteinuria ≥1 g/g
04
A qualifying biopsy performed within the last 5 years for GFR ≥ 45, within 2 years for For patients with eGFR* 30 to <45 and performed at any time for eGFR* 20 to <30