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KN019-201 is a randomized, double-blind, placebo-controlled, multicenter clinical study in which the efficacy and safety of two different doses of KN019 (5mg/kg and 10mg/kg) combined with MTX combined with placebo were compared in patients with active rheumatoid arthritis with insufficient MTX response to MTX in China, with Professor Zeng Xiaofeng of Peking Union Medical College Hospital as the principal investigator, and 23 centers across the country jointly participated in the enrollment of 145 patients
The results showed that the proportion of the American Rheumatology Association Remission Standard (ACR20/ACR50/ACR70) at 24 and 48 weeks met the efficacy standard preset by the protocol: in terms of efficacy, the response rate of ACR20 in the two dose groups KN019 5mg/kg combined with MTX and KN019 10mg/kg combined with MTX was significantly better than that of placebo plus MTX; In terms of safety, KN019 5mg/kg combined with MTX and KN019 10mg/kg combined MTX two dose groups safety data were similar, and no unexpected safety events
KN019 is a broad-spectrum immunomodulator that can be applied to immunological disorders caused by the treatment of autoimmune diseases and tumor checkpoint inhibitors
About KN019KN019 is a CTLA-4 fusion protein immunosuppressant drug developed by Corning Jerry, which has the same amino acid sequence as the marketed kidney transplant rejection drug Nulojix® (Belatacept), the blockbuster drug for specific gravity arthritis, Orencia® (Abatacept) has stronger biological activity and good safety and can be used to treat autoimmune diseases such as arthritis, lupus erythematosus, type I diabetes and immunorelated adverse reactions (irAEs)