drugset / Trial / NCT05771155
Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a multi-center, randomized, parallel arm, double-blind study with approximately 750 participants with moderately to severely active Colitis Ulcerosa randomized to receive either PB016 or Entyvio®
Timeline
- Start
- 2023-07-24
- Primary completion
- 2025-09
- Completion
- 2025-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PB016 | Unknown | 300 mg | Intravenous |
| Subject | Vedolizumab | Monoclonal antibody | 300 mg | Intravenous |