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Primary immunoplugtation (ITP) is a rare chronic autoimmune disease characterized by unpredictable symptoms of debilitating, including spontaneous bruising, bleeding, and extreme fatigue, which can greatly affect a patient's daily life.
biopharmaceutical company UCC today announced the results of its Phase II study of the research drug rozanolixizumab, the first monoclonal FcRn antibody for patients with primary immunoplate plate small plate reduction (ITP).
In this study, clinical improvements in plate plate count (i.e., plate plate count of 50x109/L) and immunoglobulin G (IgG) were observed in the single dose group (15 and 20 mg / kg) and the multi-dose group (5x4, 3x7 and 2x10 mg / kg per week, with a cumulative dose of approximately 20 mg / kg).
In particular, patients with a single infusion of 15 or 20 mg / kg (66.7% and 54.5% of patients, respectively) received an improvement in plateplate count and occurred more quickly in a single dose group than patients who received multiple infusions to achieve approximately 20 mg/kg.
lowest average IgG appeared on the 8th day in the single dose group, and in the multi-dose group it was 15 days.
most common adverse reactions are mild to moderate headache, with the highest rate in the 20mg/kg population.
other reported adverse events include diarrhea and vomiting, which were observed only in a single dose group.
adverse reactions have been resolved and there are no clinical sequelae.
no patients were terminated due to side effects.
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