The randomized, placebo-controlled GEMINI I trial has met primary endpoints of improvements in clinical response in induction and clinical remission in maintenance.
In the double-blinded trial, patients were given vedolizumab (MLN0002) or placebo treatment for a year, starting with six weeks of induction therapy.
The most common adverse events (more than 10%) such as colitis, headache and nasopharyngitis were observed in both the vedolizumab arm and the placebo arm.
Takeda chief medical and scientific officer Tadataka Yamada said they are very pleased with the outcomes of this pivotal trial, and the potential that vedolizumab holds for patients with this debilitating disease.