A randomized treatment open-label dose-blinded parallel group three arm proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy

Brief description of study

The purpose of the study is to find out if the drug called “LNP023” is safe and has beneficial effects in people who have membranous nephropathy (MN) compared with rituximab. The main objective of this research is to see whether taking LNP023 or rituximab for 6 months results in lower urine protein levels and to compare these two treatments in patients with MN. This study will also provide information on the dose of LNP023 to be used in future clinical studies with subjects who have been diagnosed with MN. LNP023 is a medicine that is not approved by the US Food and Drug Administration (FDA) for the treatment of people with MN or other disorders. It targets the alternative complement pathway, an important system in the body which provides protection against infections. However, abnormal activation of this alternative complement pathway may result in a number of different kidney diseases, including MN. LNP023 blocks key steps in the alternative complement pathway which

Clinical Study Identifier: s20-00024
ClinicalTrials.gov Identifier: NCT04154787
Principal Investigator: Olga Zhdanova.
Other Investigator: Safa M. Kalache.

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