drugset / Trial / NCT04154787

Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous Nephropathy

NCT04154787

Phase 2 Terminated 37 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

This was a randomized, open-label, two arm, parallel group, proof-of-concept, nonconfirmatory study evaluating the efficacy and safety of LNP023 compared with rituximab in subjects with Idiopathic (primary) membranous nephropathy (iMN) who are at high risk of disease progression defined on the basis of anti- Phospholipase A2 Receptor (PLA2R) antibody titer ≥ 60 RU/mL and proteinuria with urine protein (UP) ≥ 3.5 g/24h.

Timeline

Start
2019-11-23
Primary completion
2023-01-20
Completion
2023-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Iptacopan Small molecule 50 mg Oral
Subject Iptacopan Small molecule 200 mg Oral
Comparator Rituximab Monoclonal antibody 1 g Intravenous