Safety, Tolerability and Efficacy of Narsoplimab, a Novel MASP-2 Inhibitor for the Treatment of IgA Nephropathy.

ABSTRACT:

Introduction

Narsoplimab is a human monoclonal antibody against mannan-associated lectin-binding serine protease-2 (MASP-2). Now in a phase 3 study, narsoplimab was evaluated in a staged phase 2 study assessing safety and effectiveness in high-risk patients with IgA nephropathy (IgAN).

Methods

Substudy 1 was a single-arm open-label study of 12 weekly infusions and tapered corticosteroids, with 6 weeks of follow-up. In substudy 2, patients were randomized 1:1 to receive a course of treatment consisting of once-weekly narsoplimab or vehicle infusions for 12 weeks. After 6 weeks of follow-up, both substudy 2 groups could continue in an open-label extension, receiving 1 or more narsoplimab courses at the investigator's discretion.

Results

The most commonly reported advers

SUBMITTER: Lafayette RA 

PROVIDER: S-EPMC7609886 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature