Phase 3 Study to Test Safety and Effectiveness of LNK01001 in Adults With Active Ankylosing Spondylitis

What this Trial Is About

Researchers are evaluating the efficacy and safety of LNK01001 in adults with active ankylosing spondylitis, a chronic inflammatory disease affecting the spine. This Phase 3 clinical trial aims to assess how well LNK01001 works compared to a placebo in improving disease symptoms and activity. The study includes participants who have active disease despite prior treatment with nonsteroidal anti-inflammatory drugs NSAIDs. Participants are randomly assigned to one of two groups during a 16-week double-blind period one group receives LNK01001 12 mg orally twice daily, while the other receives a matching placebo twice daily. After 16 weeks, all participants enter a 36-week open-label extension in which those initially on placebo switch to LNK01001 at the same dose. This design allows researchers to compare initial responses and gather long-term safety and efficacy data. Throughout the study, participants will have regular assessments including evaluations of disease activity using the Assessment of SpondyloArthritis International Society ASAS 40 response at week 16 as the primary outcome. Other assessments include disease activity scores, pain ratings, functional indices, and quality of life questionnaires. Safety will be monitored continuously. The total participation duration is 52 weeks, with close follow-up to understand how the treatment affects symptoms and function over time.

A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis