A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Adults With Psoriatic Arthritis

What this Trial Is About

Researchers are evaluating tulisokibart MK-7240 as a possible treatment for adults with active Psoriatic Arthritis PsA. This Phase 2b study aims to assess the efficacy, safety, and tolerability of different doses of tulisokibart compared to a placebo. The goal is to determine whether any dose of tulisokibart can better reduce PsA symptoms than the placebo over a 16-week period. Participants will be randomly assigned to receive one of several treatments a high dose, medium dose, or low dose of tulisokibart, or a matching placebo. After 16 weeks, those initially on placebo or low dose will be rerandomized to a medium or high dose of tulisokibart. The study includes a 16-week placebo-controlled period followed by a long-term extension lasting up to 112 weeks, which is divided into a 40-week main extension and a 72-week optional extension. During the study, participants will receive the study drug through subcutaneous injections and undergo regular assessments to track symptom changes and safety. Researchers will measure responses such as the American College of Rheumatology 20% improvement criteria at Week 16, along with other clinical responses and patient-reported outcomes. Safety will be monitored throughout the study and extension periods, with participation lasting up to several years.

Study to Evaluate Tulisokibart in Adults With Psoriatic Arthritis (MK-7240-015)