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PB016 versus US- and EU-sourced Entyvio in healthy volunteers
NL-OMON53409Completed
- Sponsor
- Polpharma Biologics
- Start
- Jul 2022
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Countries
- 1
01
Overview
Randomised, double-blind trial of vedolizumab in autoimmune colitis, Crohn's disease and pouchitis (3 arms), sponsored by Polpharma Biologics. Primary endpoints: AUC0-last comparability: PB016 versus US-licensed Entyvio, AUC0-last comparability: PB016 versus EU-approved Entyvio and 4 more. Started Jul 2022; status: completed.
02
Drugs
vedolizumab
03
Conditions
autoimmune colitisCrohn's diseasepouchitis
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