Phase 3 trial design and key XKH004 outcomes in active ankylosing spondylitis (IMAGE)

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Phase 3 trial design and key XKH004 outcomes in active ankylosing spondylitis

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In a 37-center phase 3 trial, 323 adults with active ankylosing spondylitis were randomly assigned to receive XKH004 160 mg or placebo every four weeks for 16 weeks. At week 16, ASAS40 response rates were 45.4% with XKH004 and 19.4% with placebo; among participants with prior tumor necrosis factor inhibitor exposure, rates were 50.0% and 20.0%, respectively. After week 16, all participants received open-label XKH004. At week 52, the ASAS40 response rate was 66.2% among participants who continued XKH004; among continuously treated participants with prior tumor necrosis factor inhibitor exposure, it was 72.7%.

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hLife

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