VEDOLIZUMAB, Entyvio 300 mg powder for concentrate for solution for infusion clinical trials

A randomized, double-blind, multicenter phase 3 study in patients with moderately to severely active ulcerative colitis (UC) to compare the efficacy, safety and immunogenicity of PB016 and Entyvio® for the induction and maintenance of clinical response and remission. (UCESIVE)

This study compares a new medicine (PB016) with an existing one (Entyvio®) for adults with moderate to severe ulcerative colitis. It looks at how well they work to reduce symptoms and keep people well, as well as their safety.