A Multi-center Study to Assess the Safety and Effectiveness of CS32582 Capsules in Adults Aged 18 to 70 With Moderate to Severe Plaque Psoriasis

What this Trial Is About

Researchers are evaluating the safety and efficacy of CS32582 capsules in adults with moderate to severe plaque psoriasis. The study has two parts Part 1 is a dose escalation phase involving about 20 to 30 patients treated for 4 weeks, and Part 2 is an efficacy and safety assessment with approximately 200 patients treated for 12 weeks. The goal is to gather preliminary data to guide further development of CS32582. Participants receive varying doses of CS32582 capsules or a placebo taken twice daily. In Part 1, patients receive either low or high doses for 4 weeks. In Part 2, patients receive low, medium, or high doses for 12 weeks. Both parts are randomized and double-blind to compare different dose levels against placebo. During the study, participants undergo regular assessments including monitoring of adverse events, skin evaluations using the Psoriasis Area Severity Index PASI, static Physicians Global Assessment sPGA, Body Surface Area BSA, and quality of life questionnaires DLQI. Pharmacokinetic measures such as drug concentration in the blood are also collected. Safety and efficacy are evaluated at multiple timepoints throughout the treatment periods and follow-up.

A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis