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

Launched by ALVOTECH SWISS AG · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two treatments for people with moderate to severe active ulcerative colitis, a condition that causes inflammation in the intestines. The trial compares a new treatment called AVT16 with an established medication called Entyvio to see which one works better and is safer for patients. This study is currently recruiting participants aged 18 to 80, and both men and women can join if they meet the eligibility criteria, which include being able to give informed consent and having a diagnosis of ulcerative colitis.

Participants in the trial will be randomly assigned to receive either AVT16 or Entyvio, and neither the participants nor the researchers will know which treatment each participant is receiving until the study is completed. This helps ensure unbiased results. It’s important to note that individuals with certain conditions, like Crohn's colitis or a history of severe tuberculosis, cannot participate. Overall, this study aims to provide valuable information on how well these treatments work and their safety for those suffering from ulcerative colitis.

Gender

ALL

Eligibility criteria

• 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