Phase IIIII Study of Picankibart Injections for Adults with Active Psoriatic Arthritis

What this Trial Is About

Researchers are evaluating the efficacy and safety of picankibart IBI112 in adults with active psoriatic arthritis PsA through a multicenter, randomized, double-blind, placebo-controlled Phase IIIII clinical trial. The study aims to identify the optimal dose in Phase II and confirm effectiveness in Phase III by measuring improvements in joint symptoms, physical function, quality of life, and skin manifestations. The primary goal is to assess the percentage of participants achieving an American College of Rheumatology ACR 20 response at Week 24. Participants will be randomly assigned to receive subcutaneous injections of picankibart or placebo at scheduled times. The Phase II stage includes dose-finding with 90 participants, while the Phase III stage involves 132 participants to confirm dosing and efficacy. Placebo recipients will switch to active picankibart treatment at Week 26. Different dosing schedules are used, and the study evaluates both short- and longer-term responses. During the trial, participants will undergo regular assessments including joint evaluations, physical function questionnaires, quality of life surveys, and skin evaluations. Safety will be monitored through adverse event tracking and laboratory tests up to Week 56. Pharmacokinetic and immunogenicity measures such as plasma concentration and antibody development will also be collected. Overall participation may last up to 56 weeks, with ongoing monitoring of disease activity and treatment effects.

A Study of Picankibart in Patients With Active Psoriatic Arthritis