NCT07038382

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Membranous Nephropathy
• Lupus Nephritis (LN)

Interventions

Type	Name	Description
DRUG	HLX79 10mg/kg/Placebo+HLX01	Subjects with MN will receive HLX79 10mg/kg or placebo, combine with HLX01 375 mg/m2
DRUG	HLX79 20mg/kg/Placebo + HLX01	Subjects with MN will receive HLX79 20mg/kg or placebo combined with HLX01 375 mg/m2
DRUG	HLX79 30mg/kg/placebo+HLX01	Subjects with MN will receive HLX79 30mg/kg or placebo combined with HLX01 375 mg/m2

Timeline

• Start date: 2025-08-05
• Primary completion: 2027-01-01
• Completion: 2030-05-01
• First posted: 2025-06-26
• Last updated: 2025-11-18

Locations

17 sites across 1 country: China