NCT05755386

Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Idiopathic Immune-complex-mediated Membranoproliferative Glomerulonephritis (IC-MPGN)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.

Detailed description

The purpose of this Phase III study is to evaluate the efficacy and safety of iptacopan compared to placebo (both administered in combination with standard of care) in participants (adults and adolescents aged 12-17 years) with idiopathic IC-MPGN. The study aims to demonstrate a reduction in proteinuria and improvement in estimated glomerular filtration rate (eGFR) in participants treated with iptacopan compared to placebo. Change in patient-reported fatigue will also be evaluated. Alternative complement pathway (AP) dysregulation is believed to underlie the clinical manifestations and progression of IC-MPGN. Upon completion of study treatment, participants will have the option to discontinue iptacopan treatment and enter a 30 day safety follow-up or continue iptacopan treatment by transitioning to an open label extension study (CLNP023B12001B; NCT03955445) and continue iptacopan treatment.

Conditions

• IC-MPGN

Interventions

Type	Name	Description
DRUG	Placebo	Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
DRUG	iptacopan	iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)

Timeline

• Start date: 2023-10-02
• Primary completion: 2028-10-27
• Completion: 2029-05-31
• First posted: 2023-03-06
• Last updated: 2026-04-01

Locations

124 sites across 23 countries: United States, Argentina, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, India, Israel, Italy, Japan, Netherlands, Poland, Slovakia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, Vietnam

Regulatory

• FDA-regulated drug study