drugset / Trial / NCT06570772
Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2024-09-23
- Primary completion
- 2025-11-25
- Completion
- 2025-11-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AVT16 | Unknown | 300 mg | Intravenous |
| Comparator | Vedolizumab | Monoclonal antibody | 300 mg | Intravenous |