Phase III trial of AK111 for active ankylosing spondylitis completed with 510 patients

A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical study was conducted to evaluate the efficacy and safety of AK111 in subjects with active ankylosing spondylitis. The study enrolled 510 patients. The research period was 61 weeks in total, consisting of three parts: a screening period (Part 1), a placebo control period (Part 2), and a long-term treatment follow-up period (Part 3). The intervention arms were AK111 and Placebo+AK111. The primary outcome measure was the response rate of ASAS20. The study was completed. The lead sponsor was Akeso. The study start date was November 22, 2023, and the primary completion date was February 19, 2025. The abstract does not report specific efficacy results, safety data, statistical significance, confidence intervals, hazard ratios, odds ratios, relative risks, p-values, or detailed patient demographics. The abstract also does not report the specific dosing regimen for AK111, the duration of the individual study periods, the criteria for active disease, prior treatment requirements, or any limitations of the study design.