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Ulcerative Colitis (Ucesive)

Head-to-Head Comparative Study for Moderate-Severe Ulcerative Colitis (Ucesive Study) - No placebo risk

Study Title

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).

Purpose of Study

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).

Eligibility

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?

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CDH Research Institute

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CDH Research Institute

Complete the form to register.