NCT05771155View on ClinicalTrials.gov

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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

750

Participants

Timeline

Start Date

July 24, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Ulcerative Colitis
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

Trial Locations (1)

Unknown

Todua Clinic LLC, Tbilisi

Sponsors
All Listed Sponsors
lead

Polpharma Biologics S.A.

INDUSTRY