# Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®

> **NCT05771155** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Polpharma Biologics S.A.** · enrollment: 750 (estimated)

## Conditions studied

- Ulcerative Colitis

## Interventions

- **BIOLOGICAL:** Intravenous (IV) infusions

## Key facts

- **NCT ID:** NCT05771155
- **Lead sponsor:** Polpharma Biologics S.A.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2023-07-24
- **Primary completion:** 2025-09
- **Final completion:** 2025-09
- **Target enrollment:** 750 (ESTIMATED)
- **Last updated:** 2025-06-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05771155

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05771155, "Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®". Retrieved via MORVS 2026-11-01 from https://api.morvs.ai/clinical/NCT05771155. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*