Takeda Italia SpA

The primary objective is to evaluate the PK of Vedolizumab after a single intravenous infusion in healthy Chinese adult subjects. The secondary objective is to evaluate the safety and tolerability of Vedolizumab after a single intravenous infusion in healthy Chinese adult subjects.

The primary objective was to evaluate the efficacy of Vedolizumab IV as induction therapy in Chinese subjects with moderately to severely active CD at week 10; the secondary objective was to evaluate the effect of Vedolizumab IV on induction clinical remission in Chinese subjects with moderately to severely active CD at week 10.

The primary objective was to evaluate the efficacy of Vedolizumab IV as induction therapy and maintenance therapy in Chinese subjects with moderately to severely active UC. The secondary objectives were to evaluate the efficacy of Vedolizumab IV on clinical remission and mucosal healing at week 10 of the induction phase and on mucosal healing, durable clinical response, durable clinical remission, and corticosteroid-free remission at week 60 of the maintenance phase.