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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
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.
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
Investigational Site 161704
Ciudad Autónoma de BuenosAires, Argentina
Investigational Site 161702
Córdoba, Argentina
Investigational Site 161701
Quilmes, Argentina
Investigational Site 161705
San Miguel de Tucumán, Argentina
Investigational Site 160111
Burgas, Bulgaria
Investigational Site 160102
Pleven, Bulgaria
Investigational Site 160109
Rousse, Bulgaria
Investigational Site 160101
Sliven, Bulgaria
Investigational Site 160103
Sofia, Bulgaria
Investigational Site 160105
Sofia, Bulgaria
Start Date
September 23, 2024
Primary Completion Date
November 25, 2025
Completion Date
November 25, 2025
Last Updated
December 26, 2025
301
ACTUAL participants
AVT16
BIOLOGICAL
Vedolizumab
BIOLOGICAL
Lead Sponsor
Alvotech Swiss AG
NCT07271069
NCT06975722
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07185009