Phase 3 Trial of Vedolizumab for Ulcerative Colitis

Takeda announced results from the GEMINI I Phase 3 trial evaluating vedolizumab in patients with moderately to severely active ulcerative colitis who have failed at least one conventional therapy, including TNFα antagonists.

The international, randomized, placebo-controlled, double-blind GEMINI I Phase 3 study enrolled 895 patients at more than 210 sites in more than 34 countries. Patients received a year of vedolizumab (MLN0002) or placebo treatment, 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 phase.

Vedolizumab is a humanized monoclonal antibody against α4β7 integrin, which is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis and Crohn's disease.

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