荃信生物-B(02509)：鲁塞奇塔单抗(QX002N)强直性脊柱炎III期临床研究成果亮相2025年ACR年会

Core Insights - The company announced the results of its Phase III clinical trial for QX002N (Lusacitinib) in treating ankylosing spondylitis (AS), which will be presented at the ACR Convergence 2025 in Chicago [1] Group 1: Clinical Trial Details - The Phase III trial was led by Professor Zeng Xiaofeng from the Peking Union Medical College Hospital and involved 641 patients across 58 centers in China [1] - The study was a multi-center, randomized, double-blind, placebo-controlled trial with a treatment period of 48 weeks, including a 16-week double-blind phase and a 32-week open-label phase [1] - Patients were randomly assigned in a 1:1 ratio to receive either 160mg Lusacitinib or a placebo, administered subcutaneously every four weeks [1] Group 2: Efficacy Results - At week 16, the ASAS40 response rate for the Lusacitinib group was 40.4%, significantly higher than the placebo group's 18.9% (P<0.0001) [1] - The ASAS20 response rate for the Lusacitinib group was 65.2%, also significantly higher than the placebo group (P<0.0001) [1] - The results indicate that Lusacitinib effectively alleviates symptoms and signs of AS from multiple dimensions, including pain and spinal function [1] Group 3: Imaging and Safety Assessment - MRI assessments showed that the Lusacitinib group had a change in spinal score of -8.1 and a change in sacroiliac joint score of -6.2, both significantly better than the placebo group's -1.4 and -2.3 [2] - The findings provide objective imaging evidence that Lusacitinib can effectively reduce edema and inflammation in the spine and sacroiliac joints [2] - The incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) in the Lusacitinib group was similar to that of the placebo group, with most TEAEs being mild to moderate, indicating good overall safety [2] Group 4: Future Prospects - The promising clinical efficacy and clear imaging evidence position Lusacitinib as a potential new treatment option for AS patients [2] - The company plans to expedite the registration application process to seek early approval for market launch [2]