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A Randomized, Double-Blind, Multicenter Phase 3 Study in Patients with Moderately to Severely active ulcerative colitis (UC) to compare the efficacy, safety and immunogenicity of PB016 and Entyvio® for the induction and maintenance of clinical response and remission. (UCESIVE).
PB016 is a proposed vedolizumab biosimilar under development to treat the same indications using the same routes of administration and dosing regimens as the vedolizumab containing reference product, Entyvio®. This study is designed to demonstrate equivalent clinical response of IV formulations of PB016 and Entyvio® as treatment for moderately to severely active ulcerative colitis (UC).
You may be eligible for the study if you meet the following criteria.
Please contact CDH Research Institute on 07 5408 0900 for additional information or use the email link below. You can also share details of this study to social media via the links below?
Clinical trials are important because they serve as the foundation for most medical advances.
