Status:
TERMINATED
Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
Lead Sponsor:
Alvotech Swiss AG
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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 mode...
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
Inclusion
- Capable of giving signed informed consent
- Male and female subjects from 18 to 80 years of age
- Diagnosis of Ulcerative Colitis
Exclusion
- Diagnosis of Crohn's colitis
- Extensive colonic resection
- Active or latent tuberculosis
Key Trial Info
Start Date :
September 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2025
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT06570772
Start Date
September 23 2024
End Date
November 25 2025
Last Update
December 26 2025
Active Locations (100)
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1
Investigational Site 161704
Ciudad Autónoma de BuenosAires, Argentina
2
Investigational Site 161702
Córdoba, Argentina
3
Investigational Site 161701
Quilmes, Argentina
4
Investigational Site 161705
San Miguel de Tucumán, Argentina