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

NCT05771155 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2025-06-17

No results posted yet for this study

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®

Conditions

Interventions

BIOLOGICAL

Intravenous (IV) infusions

Intravenous (IV) infusions of a dose of 300mg, on Weeks 0, 2 and 6, 14, 22, 30, 38 and 46

Sponsors & Collaborators

  • Polpharma Biologics S.A.

    lead INDUSTRY

Principal Investigators

  • Agnes Rethy, MD · Polpharma Biologics S.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Georgia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05771155 on ClinicalTrials.gov