[Translation] A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial of recombinant anti-human IL-17A/F humanized monoclonal antibody injection in the treatment of moderately to severely active ankylosing spondylitis (AS)
主要目的:
以治疗16周时达到ASAS 40的患者比例评价XKH004治疗中重度活动性AS的疗效
关键次要目的:
以治疗16周时达到ASAS 20的患者比例评价XKH004治疗中重度活动性AS的疗效
其他次要目的:
以其他疗效指标评价XKH004治疗中重度活动性AS的疗效
评价XKH004对中重度活动性AS患者生活质量的改善作用
评价XKH004在活动性AS患者中的群体药代动力学(PPK)特征
进一步评价XKH004在活动性AS患者中的安全性和免疫原性
[Translation] Primary objective:
To evaluate the efficacy of XKH004 in the treatment of moderately to severely active AS by the proportion of patients reaching ASAS 40 at 16 weeks of treatment
Key secondary objectives:
To evaluate the efficacy of XKH004 in the treatment of moderately to severely active AS by the proportion of patients reaching ASAS 20 at 16 weeks of treatment
Other secondary objectives:
To evaluate the efficacy of XKH004 in the treatment of moderately to severely active AS by other efficacy indicators
To evaluate the effect of XKH004 on the improvement of the quality of life of patients with moderately to severely active AS
To evaluate the population pharmacokinetic (PPK) characteristics of XKH004 in patients with active AS
To further evaluate the safety and immunogenicity of XKH004 in patients with active AS