This is a multi-center, randomized, parallel arm, double-blind study with a total duration of 54 weeks. Approximately 750 participants with moderately to severely active Colitis Ulcerosa will be randomized to receive up to eight doses of either PB016 or Entyvio®.~The study will be conducted at up to 200 study centers, located in approximately 18 countries worldwide.~The clinical trial is designed to compare the efficacy, safety, and immunogenicity of 300 mg IV PB016 versus Entyvio® in patients with moderately to severely active UC.~The active period of Study PB016-03-01 comprises the following:~Stage 1: Induction Period - after 1:1 randomization, intravenous infusions of either PB016 or Entyvio® at a dose of 300 mg at Weeks 0 and 2.~Stage 2: Maintenance Period - further doses at Weeks 6, 14, 22, 30, 38, and 46.~Stage 3: Follow-up Period - At Week 54, a safety follow-up call will be conducted.
This is a multi-center, randomized, parallel arm, double-blind study with approximately 750 participants with moderately to severely active Colitis Ulcerosa randomized to receive either PB016 or Entyvio®