NCT06570772

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

Parallel-Group Treatment, Double-Blind, 2-Arm to Investigate Comparative Efficacy Safety Immunogenicity Between Intravenous AVT16 and Entyvio® in Male and Female Subjects 18 to 80 Years Inclusive, Moderate to Severe Ulcerative Colitis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Alvotech Swiss AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
BIOLOGICAL	AVT16	AVT16 will be given as iv infusion at Wks 0, 2, 6, 14, 22, 30, 38 and 46
BIOLOGICAL	Vedolizumab	Entyvio (vedolizumab) will be given as iv infusion at Wks 0, 2, 6, 14, 22, 30, 38 and 46

Timeline

• Start date: 2024-09-23
• Primary completion: 2025-11-25
• Completion: 2025-11-25
• First posted: 2024-08-26
• Last updated: 2025-12-26

Locations

100 sites across 11 countries: Argentina, Bulgaria, Croatia, Georgia, Latvia, Poland, Romania, Serbia, Slovakia, Sri Lanka, Ukraine