The study has been terminated based on Sponsor decision. This decision is not related to any safety concerns associated with the investigational products. It is related to the fact that study will be not required for product dossier submission.

The study has been designed as a randomised, parallel-group, double-blind, 2 arm study of the comparative efficacy, safety and immunogenicity of AVT16 and Entyvio in male and female subjects with moderate to severe active ulcerative colitis.

The study will consist of a screening period, a treatment and assessment period and an End of Study visit. Eligibility for the study will be determined during a screening period. Subjects who meet the eligibility criteria will be randomised to either AVT16 or Entyvio.

Inclusion Criteria:

• Capable of giving signed informed consent
• Male and female subjects from 18 to 80 years of age
• Diagnosis of Ulcerative Colitis

Exclusion Criteria:

• Diagnosis of Crohn's colitis
• Extensive colonic resection
• Active or latent tuberculosis