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

NCT06570772 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2025-12-26

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Alvotech Swiss AG

    lead INDUSTRY

Principal Investigators

  • Eveline Schurink · Alvotech Swiss AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-23
Primary Completion
2025-11-25
Completion
2025-11-25

Countries

  • Argentina
  • Bulgaria
  • Croatia
  • Georgia
  • Latvia
  • Poland
  • Romania
  • Serbia
  • Slovakia
  • Sri Lanka
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06570772 on ClinicalTrials.gov