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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

StatusRecruiting
PhasePhase 2
Started2025-08-05
View on ClinicalTrials.gov ↗

Amendment history

2025-11-14
Study Status, Eligibility v2
Start dateestimated 2025-08-31→confirmed 2025-08-05
Eligibility criteria+216 characters
[...] e to complete all study procedures. Male or female, aged 18-7075 years (both inclusive) at the time of signing the ICF. Diagnosed with primary membranous nephropathy (MN) within 15 year prior to screening If a diagnosis of primary MN is con [...] g high-risk criteria: Urine protein > 8 g/24 h at screening.(The above 3-month ACEI/ARB treatment observation period is not required) eGFR ≥ 60 mL/min/1.73 m2 and urine protein > 3.5 g/24 h at screening, and must meet at least one of the following at screening: Anti-PLA2R antibody > 50 relative units (RU)/mL; Serum albumin < 25 g/L; Urine alpha 1 microglobul [...] [...]
2025-07-29
Study Status, Outcome Measures, Eligibility v1
Eligibility criteria+452 characters
[...] opsy diagnosis obtained during screening should be available, or patients with nephrotic syndrome and a positive anti-PLA2R antibody test within 6 months prior to screening; secondary MN (secondary to infection, tumor, SLE, drugs, e [...] judged by the investigator for 3 months prior to screening (unless intolerance to ACEI/ARB, contraindications to their use or a low blood pressure that could induce side effects, at the investigator's discretion) and also meet one of the following high-risk criteria: Urine [...] rms of mycophenolate) within 1 month prior to randomization Treatment with calcineurin inhibit [...] [...]
Secondary endpoints17 to 18 entries
Explore the biomarkers
2025-06-25
Original filing
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.
Trial Details
NCT Number NCT07038382
Lead Sponsor Shanghai Henlius Biotech
Conditions Membranous Nephropathy, Lupus Nephritis (LN)
Enrollment 24 participants
Start Date 2025-08-05
Primary Completion 2027-01 (estimated)
Study Completion 2030-05 (estimated)
Updated on ClinicalTrials.gov 2025-11-18