Novartis Q4 Results
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iptacopan - CFB inhibitor
Company overview
Financial review
Conclusions
Appendix
Innovation: Pipeline overview
Financial performance
Innovation: Clinical trials
> Cardiovascular, Renal
and Metabolic
Immunology
Neuroscience
Oncology
Other
Global Health
Abbreviations
References
NCT04578834 APPLAUSE-IgAN (CLNP023A2301)
iptacopan - CFB inhibitor
NCT05755386 APPARENT (CLNP023B12302)
Indication
Phase
Immune complex-mediated membranoproliferative glomerulonephritis
Phase 3
Indication
IgA nephropathy
Phase
Phase 3
Patients
450
Patients
68
Primary
Outcome
Ratio to baseline in urine protein to creatinine ratio (sampled from 24h urine
collection) at 9 months
Measures
Annualized total estimated Glomerular Filtration Rate (eGFR) slope estimated
over 24 months
Primary
Outcome
Measures
Target Patients
Log-transformed ratio to baseline in UPCR (sampled from a 24-hour urine
collection) at 6 months. [ Time Frame: 6 months (double-blind) ]
To demonstrate the superiority of iptacopan compared to placebo in reducing
proteinuria at 6 months.
Log-transformed ratio to baseline in UPCR at the 12-month visit (both study
treatment arms) [ Time Frame: 12 months]
To evaluate the effect of iptacopan on proteinuria at 12 months.
Log-transformed ratio to 6-month visit in UPCR at the 12-month visit in the
placebo arm. [ Time Frame: 12 months ]
To evaluate the effect of iptacopan on proteinuria at 12 months.
Arm 1 experimental: Drug: iptacopan 200 mg b.i.d. (Adults 200mg b.i.d;
Adolescents 2x 100mg b.i.d)
Arm 2 placebo to iptacopan 200mg b.i.d.
(both on top of SoC)
Patients (adults and adolescents aged 12-17 years) with idiopathic IC-MPGN
Arms
Arm 1 LNP023 200mg BID
Intervention
Arm 2 - Placebo BID
Target Patients
Primary IgA Nephropathy patients
Readout
Milestone(s)
Publication
2023 (primary endpoint for US initial submission, 9 months UPCR)
2025 (24 months)
Arms
Intervention
TBD
□ NOVARTIS Reimagining Medicine
Readout
Milestone(s)
Publication
2026
Vivarelli M, et al., Kidney International Reports (2023), Iptacopan in idiopathic
immune complex-mediated membranoproliferative glomerulonephritis: Protocol of
the APPARENT multicenter, randomized Phase III study
Novartis Q4 Results | January 31, 2024
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