Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients
Summary
The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (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.
Timeline
- Start
- 2021-01-25
- Primary completion
- 2025-09-19
- Completion
- 2025-09-19
Outcome
Met primary endpoint
paper difference, 3.02 ml per minute per 1.73 m2 per year; 95% confidence interval [CI], 2.02 to 4.01; adjusted P<0.001). PMID 41910396 ↗
paper Iptacopan therapy led to a significantly slower decline in kidney function than placebo. PMID 41910396 ↗
release “Phase III APPLAUSE-IgAN study met its pre-specified interim analysis primary endpoint” novartis.com ↗
release “Iptacopan Ph3 APPLAUSE-IgAN met its primary endpoint in IgAN patients” novartis.com ↗
release “In APPLAUSE-IgAN final analysis, Fabhalta demonstrated statistically significant, clinically meaningful improvement in estimated glomerular filtration rate (eGFR) slope vs. placebo over two years” novartis.com ↗
Publications
- Barratt J, Eren N, Kashihara N, Maes B, Rizk DV, Rovin B, Trimarchi H, Zhang H, Wang W, Kocyigit I, Hao C, Tesar V, Turgutalp K, Yang L, Xing G, Duro Garcia V, Han SH, Lu W, Pisani A, Weinmann-Menke J, Eitner F, Guerard N, Butylin D, Monaco L, Scosyrev E, Magirr A, Renfurm R, Hach T, Perkovic V; APPLAUSE-IgAN Study Group. Iptacopan in IgA Nephropathy - Final 24-Month Data. N Engl J Med. 2026 Mar 29. doi: 10.1056/NEJMoa2600743. Online ahead of print.
- Perkovic V, Barratt J, Rovin B, Kashihara N, Maes B, Zhang H, Trimarchi H, Kollins D, Papachristofi O, Jacinto-Sanders S, Merkel T, Guerard N, Renfurm R, Hach T, Rizk DV; APPLAUSE-IgAN Investigators. Alternative Complement Pathway Inhibition with Iptacopan in IgA Nephropathy. N Engl J Med. 2025 Feb 6;392(6):531-543. doi: 10.1056/NEJMoa2410316. Epub 2024 Oct 25.
- Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
- Zhang H, Rizk DV, Perkovic V, Maes B, Kashihara N, Rovin B, Trimarchi H, Sprangers B, Meier M, Kollins D, Papachristofi O, Milojevic J, Junge G, Nidamarthy PK, Charney A, Barratt J. Results of a randomized double-blind placebo-controlled Phase 2 study propose iptacopan as an alternative complement pathway inhibitor for IgA nephropathy. Kidney Int. 2024 Jan;105(1):189-199. doi: 10.1016/j.kint.2023.09.027. Epub 2023 Oct 31.
- El Karoui K, Fervenza FC, De Vriese AS. Treatment of IgA Nephropathy: A Rapidly Evolving Field. J Am Soc Nephrol. 2024 Jan 1;35(1):103-116. doi: 10.1681/ASN.0000000000000242. Epub 2023 Sep 29.
- Reich HN, Floege J. How I Treat IgA Nephropathy. Clin J Am Soc Nephrol. 2022 Aug;17(8):1243-1246. doi: 10.2215/CJN.02710322. Epub 2022 Jun 8. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iptacopan | Small molecule | 200 mg | Oral |