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

Phase 3

Recruiting

• Conditions: Ulcerative Colitis
• Interventions: Biological: Vedolizumab; Biological: AVT16

• Registration Number: NCT06570772
• Lead Sponsor: Alvotech Swiss AG

Brief 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.

Study Timeline

• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Study First Posted: 2024-08-26
• Study Start: 2024-09-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-03-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 748

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Entyvio	Vedolizumab	Entyvio (vedolizumab) 300mg iv is the proposed active comparator for AVT16
AVT16	AVT16	Experimental Arm AVT16 300mg iv is the proposed biosimilar for Entyvio (vedolizumab)

Primary Outcome Measures

Name	Time	Method
Clinical Response at week 6	Week 6	Change in Mayo Score/Disease Activity for Ulcerative Colitis. Scale 0-12, higher score - worse outcome

Secondary Outcome Measures

Name	Time	Method
Clinical Response at week 52	Week 52	Change in Mayo Score/Disease Activity for Ulcerative Colitis. Scale 0-12, higher score - worse outcome

Trial Locations

Locations (99)

Investigational Site 161704; 🇦🇷 Ciudad Autónoma de BuenosAires, Argentina

Investigational Site 161702; 🇦🇷 Cordoba, Argentina

Investigational Site 161701; 🇦🇷 Quilmes, Argentina

Investigational Site 161705; 🇦🇷 Tucumán, Argentina

Investigational Site 160111; 🇧🇬 Burgas, Bulgaria

Investigational Site 160102; 🇧🇬 Pleven, Bulgaria

Investigational Site 160109; 🇧🇬 Ruse, Bulgaria

Investigational Site 160101; 🇧🇬 Sliven, Bulgaria

Investigational Site 160103; 🇧🇬 Sofia, Bulgaria

Investigational Site 160105; 🇧🇬 Sofia, Bulgaria

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