Evaluating Safety and Effects of Surovatamig Injection in Adults With Antibody-Positive Primary Membranous Nephropathy

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of surovatamig, given by subcutaneous injection, in adults with primary membranous nephropathy pMN who have anti-PLA2R antibodies and persistent heavy proteinuria. This Phase II open-label study focuses on patients at high risk of progressing to end-stage kidney disease and is conducted across 30 to 40 sites in about 10 countries. The study includes two parts with multiple dosing schedules to assess the treatment thoroughly. Participants will receive surovatamig by injection during the treatment periods. The study consists of two parts Part A with multiple ascending doses and sentinel dosing, and Part B with multiple ascending doses. Each part includes a screening period, a treatment period, and a follow-up period, with the total study duration lasting up to 26 months. Participants receive the investigational drug and are monitored throughout these stages. During the study, participants will undergo various assessments including urine protein measurements, anti-PLA2R antibody levels, B-cell counts, and patient-reported symptom experiences. Safety is monitored by tracking adverse events throughout the study, which lasts on average two years. Pharmacokinetic measures, such as plasma concentration levels of surovatamig, and immunogenicity evaluations are also included. Regular visits will support ongoing evaluation of treatment effects and participant health.

A Study to Assess the Effect of Surovatamig in Adult Participants With Antibody-mediated Kidney Disease