Phase II Study of HLX79 Combined With Rituximab Injection to Treat Active Glomerulonephritis Including Membranous Nephropathy

What this Trial Is About

Researchers are studying the safety and tolerability of HLX79 combined with HLX01 compared to placebo combined with HLX01 in treating active glomerulonephritis, specifically membranous nephropathy MN and lupus nephritis LN. This phase II randomized, controlled, multicenter study aims to evaluate pharmacokinetics, pharmacodynamics, immunogenicity, and clinical efficacy of these treatments for patients with these kidney conditions. Participants will receive one of three doses of HLX79 10, 20, or 30 mgkg or placebo, all combined with a fixed dose of HLX01 375 mgm2. After the initial treatment period, participants enter a 20-week follow-up phase, followed by assessments to determine the need for a second treatment period. Those not requiring further treatment will continue with follow-up until completing a total of 48 weeks. Throughout the study, participants undergo regular monitoring including laboratory tests to track abnormal values and adverse events related to treatment over 24 weeks. Safety, drug levels, immune responses, clinical efficacy, and biomarker changes are assessed up to 52 weeks. The study also includes long-term follow-up to observe ongoing effects and safety for nearly one year after treatment initiation.

A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis