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

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

Recruiting
18-80 years
All
Phase 3
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Overview

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.

Description

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.

Eligibility

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

Study details
    Ulcerative Colitis

NCT06570772

Alvotech Swiss AG

1 September 2025

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