Takeda's vedolizumab meets primary endpoints in Ph III Crohn's disease study

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) has reported positive top-line results from the international, randomized, placebo-controlled, double-blind GEMINI II pivotal Phase III trial with its Crohn’s disease drug candidate vedolizumab.

The trial evaluated vedolizumab in 1,115 patients with moderately to severely active Crohn’s disease who have failed at least one conventional therapy, including TNF alfa antagonists. Many of the patients included in the study had failed two or more TNF alfa 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, although not statistically significant.

The most common adverse events (>10%) reported in both the vedolizumab arm and the placebo arm were: Crohn’s disease, arthralgia (joint pain), pyrexia (fever), nasopharyngitis (upper respiratory inflammation), headache, nausea, and abdominal pain. Detailed results will be presented at an upcoming medical congress.