A Phase 4 Open-Label Study to Evaluate Vedolizumab IV Dose Optimization on Treatment Outcomes In Nonresponders With Moderately to Severely Active Ulcerative Colitis (ENTERPRET)
The drug being tested in this study is called Vedolizumab. Vedolizumab will be administered as an IV infusion. It is being tested in this study with new doses. This study will investigate the efficacy and safety of dose optimization of vedolizumab IV, compared with standard dosing of vedolizumab IV, over a 30-week treatment period.
The study will enroll approximately 200 moderately to severely active patients with ulcerative colitis in order to randomize 100 nonresponder patients. Participants will receive induction therapy of vedolizumab IV 300 mg on Day 1 and Week 2 (Lead-in Period). At Week 5, serum vedolizumab concentration will be measured. At Week 6, participants will be assessed for clinical response based on partial Mayo score.
Results of both Week 5 vedolizumab concentration and Week 6 clinical response will determine the treatment pathway. Those who are non-responders based on partial Mayo score at Week 6 and who are assessed as having high vedolizumab clearance, based on a predefined Week 5 serum vedolizumab concentration threshold (>50 µg/mL) will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:
Vedolizumab IV Standard Treatment
Vedolizumab IV Dose Optimized
All randomized participants will receive vedolizumab IV either 300 mg or 600 mg every 4 or 8 weeks.
This multi-center trial will be conducted in United States of America and Canada. The overall time to participate in this study is 56 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone, 6 months after last dose of study drug for a long term follow-up safety survey.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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