Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio

Summary

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.

Timeline

Start

2024-09-23

Primary completion

2025-11-25

Completion

2025-11-25

Outcome

Outcome not reported

Stopped (Business): “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.”

Drugs

Indications