Efficacy and Safety of Picankibart in Treating Moderate-to-Severe Palmoplantar Pustulosis: A Prospective, Single-Arm, Open-Label Clinical Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Picankibart in treating moderate-to-severe palmoplantar pustulosis, a skin condition characterized by pustules on the palms and soles. This is a prospective, single-arm, open-label clinical study conducted by the Department of Dermatology at the First Affiliated Hospital of Air Force Medical University, aiming to enroll 60 participants aged 18 to 65 years who have not adequately responded to or tolerated conventional systemic treatments. Participants receive Picankibart through subcutaneous injections in two phases. During the induction phase, Picankibart 200 mg is given at Weeks 0, 4, and 8. The maintenance phase follows with Picankibart 100 mg administered at Weeks 20, 32, and 44. There is no comparator group, and all participants receive the study drug openly without blinding. Throughout the study, participants will be monitored for changes in the Palmoplantar Pustular Psoriasis Area and Severity Index (PPPASI) at 16 weeks, which serves as the primary outcome measure. The study includes regular follow-up visits to assess treatment response, safety, and adherence. Participants may withdraw at any time, and safety will be closely observed for any adverse events during the trial period, which extends until the end of 2027.

Picankibart in Palmoplantar Pustulosis