NCT04578834

Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 518 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of the study is to evaluate the efficacy and safety of iptacopan (LNP023) compared to placebo on proteinuria reduction and slowing disease progression in primary IgAN patients. The study will be the pivotal trial for registration of LNP023 in IgA Nephropathy patients with the aim to demonstrate a clinically meaningful reduction in proteinuria by LNP023 vs. placebo as assessed by reduction in urine protein to creatinine ratio (UPCR) sampled from a 24 hour urine collection at an IA at 9 months. The trial will continue in a blinded fashion to confirm long-term efficacy based on annualized total slope of eGFR decline over 24 months to provide confirmatory evidence of LNP023 efficacy and safety in treating patients with IgAN. The trial will enroll approximately 470 participants; 430 biopsy-proven IgAN participants with eGFR ≥30 mL /min/1.73m2 (main study population) and up to approximately 40 participants with eGFR 20 to \<30 mL/min/1.73m2 (severe renal impairment (SRI) population).

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
DRUG	Placebo	Placebo to LNP023 200mg b.i.d
DRUG	LNP023	LNP023 200mg b.i.d

Timeline

• Start date: 2021-01-25
• Primary completion: 2025-09-19
• Completion: 2025-09-19
• First posted: 2020-10-08
• Last updated: 2025-12-23

Locations

177 sites across 35 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Russia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study