Vedolizumab (Takeda) meets endpoints in Phase III Ulcerative Colitis trial

The GEMINI I Phase III trial evaluating vedolizumab, from Takeda, for Ulcerative Colitis has met its endpoints. The study involved 895 patients with moderately to severely active Ulcerative Colitis who have failed at least one conventional therapy, including tumour necrosis factor-alpha antagonists, such as Abbott Laboratories Humira. Patients received a year of vedolizumab, also known as MLN0002, or placebo, starting with six weeks of induction therapy. Both phases of the trial met their primary endpoints, providing statistically significant improvements in clinical response in the induction phase and clinical remission in the maintenance stage. Detailed results will be presented at an upcoming medical congress.