Long-Term Extension Study of Zasocitinib for Adults With Active Psoriatic Arthritis to Assess Safety and Effectiveness

What this Trial Is About

Psoriatic arthritis PsA is a chronic inflammatory condition affecting the joints and skin. This trial evaluates the long-term safety, tolerability, and effectiveness of the drug zasocitinib in adults with active PsA, including those who have not previously used biologic DMARDs or those with inadequate response to biologic DMARDs. The study is a phase 3, multicenter, randomized, quadruple-blind trial designed as a long-term extension to previous parent studies, focusing on continued treatment with zasocitinib. Participants who completed a 52-week treatment in one of the parent studies may join this continuation study. All participants will receive oral zasocitinib once daily at one of two doses Dose A or Dose B for up to 104 weeks. Those previously assigned to zasocitinib will continue their dose, and those previously on an active comparator will be re-randomized to one of the zasocitinib doses. After treatment, a 4-week follow-up period will monitor health. During the study, participants will undergo regular safety assessments including monitoring of adverse events, vital signs, and laboratory values up to week 108. Effectiveness will be evaluated by measuring response criteria such as ACR20, ACR50, ACR70, minimal disease activity, and improvements in skin symptoms at weeks 24, 48, and 104. The entire participation period is approximately two years, including treatment and follow-up to ensure comprehensive long-term data collection.

Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis