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
A Randomized, Controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of HLX79 (Human Sialidase Fusion Protein) in Combination With Rituximab Injection (HLX01, Anti-CD20 Antibody) Versus Placebo in Patients With Active Glomerulonephritis
Shanghai Henlius Biotech
24 participants
Aug 5, 2025
INTERVENTIONAL
Conditions
Summary
The primary objectives of this clinical trial is to evaluate the safety and tolerability of HLX79 in combination with HLX01 versus placebo in combination with HLX01 in the treatment of glomerulonephritis. The secondary objective are to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HLX79 and HLX01, the clinical efficacy, the dynamic changes of biomarkers of HLX79 in combination with HLX01 in the treatment of glomerulonephritis. The subjects will receive different doses of HLX79 (10, 20, or 30 mg/kg) or placebo, all in combination with HLX01. After the end of the first treatment period, subjects will enter a 20-week follow-up period and then undergo pre-second treatment period assessments. If the investigator determines that the subject does not require the second treatment period, the subject will continue in follow-up until completing the total 48-week follow-up period.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Subjects with MN will receive HLX79 10mg/kg or placebo, combine with HLX01 375 mg/m2
Subjects with MN will receive HLX79 20mg/kg or placebo combined with HLX01 375 mg/m2
Subjects with MN will receive HLX79 30mg/kg or placebo combined with HLX01 375 mg/m2
Locations(17)
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NCT07038382