Study of Secukinumab 300mg to Treat Active Ankylosing Spondylitis in Chinese Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of secukinumab 300 mg in Chinese adults with active ankylosing spondylitis AS who have not responded well or cannot tolerate at least two non-steroidal anti-inflammatory drugs NSAIDs and who have not previously used biologic disease-modifying anti-rheumatic drugs bDMARDs. This Phase 4 study aims to understand how this treatment works in this specific patient group. The study has two parts a 16-week period where participants are randomly assigned to receive either secukinumab 300 mg or a placebo in a double-blind setup, followed by a 52-week open-label extension where all participants receive secukinumab 300 mg. The treatment starts with weekly injections of 150 mg for five weeks, then continues with maintenance injections of either 150 mg or 300 mg every four weeks for up to 48 weeks. Participants will undergo various evaluations including disease activity scores, MRI scans, quality of life assessments, and functional indexes at baseline and throughout the study, particularly at weeks 24 and 48. Researchers will monitor the percentage of participants achieving specific responses to treatment and observe changes in disease activity and work productivity. The total study duration is approximately 68 weeks, allowing for long-term safety and efficacy monitoring.

A Study Evaluating the Efficacy of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis