A study of the efficacy and safety of VSA012 Injection compared to eculizumab for 24 weeks in patients with PNH.
Male and female participants ≥ 18 years of age and BMI ≥ 18.0 kg/m2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size≥10%.
Mean hemoglobin level <100 g/L at screening.
LDH > 1.5 x Upper Limit of Normal (ULN) at screening.
Vaccination against Neisseria meningitidis infection is required prior to the
Known or suspected hereditary or acquired complement deficiency;
Presence or suspicion of a systemic active bacterial, viral, or fungal infection
History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
Patients with reticulocytes <100x10^9/L; platelets <30x10^9/L; neutrophils <0.5x10^9/L.
Parallel
VSA012
DrugVSA012 Injection
Eculizumab (Soliris®)
DrugEculizumab injection
The proportion of patients with sustained hemoglobin levels ≥ 120 g/L among those without RBC transfusion (defined as no red blood cell infusion after W2 to W26).
Proportion of participants achieving a sustained increase from baseline in hemoglobin levels of ≥ 20 g/L assessed among those without RBC transfusion (defined as no red blood cell infusion after W2 to W26).
The proportion of patients with hemolysis controlled (defined as LDH < 1.5 ULN) among those without RBC transfusion
Change (Expressed as Percentages) in Hb level from baseline
The proportion of patients without RBC transfusion
Incidence and severity of AEs
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