Phase 3 Trial of Vedolizumab for Crohn's Disease
Takeda announced results from the GEMINI II Phase 3 trial evaluating vedolizumab in patients with moderately to severely active Crohn's disease who have failed at least one conventional therapy, including TNFα antagonists.
The international, randomized, placebo-controlled, double-blind trial evaluated vedolizumab in 1,115 patients. Many of the patients included in the study had failed two or more TNFα antagonists. Patients received a year of vedolizumab (MLN0002) or placebo treatment, starting with six weeks of induction therapy. In both phases of the trial, induction and maintenance, vedolizumab demonstrated statistically significant improvement in the primary endpoint of clinical remission compared to placebo. Additionally, vedolizumab provided a numerically higher rate of enhanced response, the other primary end point in the induction 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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