Research Project

Project Title:	Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous Nephropathy
Project Type:	Clinical Trial, Enrolment ongoing
Disease group(s):	Hereditary glomerulopathies
Project Summary:	This is a randomized, treatment open-label, dose-blinded parallel group, three arm, proof-of-concept, non-confirmatory study evaluating the efficacy and safety of LNP023 compared with rituximab in subjects with MN who are at high risk of disease progression defined on the basis of antibody anti-PLA2R titre and proteinuria. The screening period will last up to 12 weeks and the whole study will last up to 65 weeks. Approximately 72 subjects will be randomized to one of three arms. Treatment with LNP023 or rituximab is open label, although dose of LNP023 will be blinded for subjects, investigators and sponsor. Both of the low and high-dose LNP023 arms have a 4-week period of initial dose treatment, followed by a 20-week period of full dose treatment to evaluate the effect of the different LNP023 doses on complement biomarkers. Efficacy will be evaluated at the end of the 24-week treatment period. The randomization ratio is 1:1:1; low-dose (regimen A) LNP023: high dose (regimen B) LNP023: rituximab.
Lead principal investigator(s):	Bertrand Knebelmann, Paris
Project Period:	02/2020 - 12/2022
Sponsors:	Industry
ClinicalTrials.gov:	NCT04154787