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

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

Outcome

Missed primary endpoint

Stopped (Business): “Sponsor decision”

registry analysis (superiority test); LNP023 200 mg b.i.d. vs Rituximab; p = 0.2670 NCT04154787 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Iptacopan	Small molecule	50 mg	Oral
Subject	Iptacopan	Small molecule	200 mg	Oral
Comparator	Rituximab	Monoclonal antibody	1 g	Intravenous

Indications