Vedolizumab-4003 (ENTERPRISE), Protocol Amendment 1, 29-Feb-2016
Research type
Research Study
Full title
A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn’s Disease (ENTERPRISE)
IRAS ID
181549
Contact name
Simon Travis
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc.
Eudract number
2015-000852-12
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
009125, IND Number
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
The drug being tested in this study is called vedolizumab IV [intravenous(ly)],which is being tested to treat people who have fistulizing Crohn's disease (CD). This study will look at fistula healing in people who take vedolizumab IV.
Patients in both treatment groups will have had surgical seton placement as standard of care prior to enrollment in the study. A seton is a slim plastic tube that is inserted through the fistula to facilitate drainage. Setons may be removed at or after Week 10 at the discretion of the investigator, provided that significant reduction in fistula drainage has occurred. All setons are recommended to be removed by Week 14 and must be removed by Week 22.The study will enroll approximately 126 patients. Participants will be randomly assigned to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
• Group 1: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 14 and 22, and a placebo infusion at Week 10 (dummy inactive infusion - this is a solution that looks like the study drug but has no active ingredient).
• Group 2: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 10, 14 and 22.The choice of different active treatment groups, rather than a placebo comparator group was made due to ethical considerations. MRI, read by a central reader, will be used to ensure consistent classification of fistulae, to objectively measure fistulae healing and assess change in inflammatory process.
This trial will be conducted worldwide. The overall time from screening to 18 weeks after the last dose is 43 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 follow-up assessment.
The study will be conducted in NHS hospitals throughout UK.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
16/SC/0254
Date of REC Opinion
7 Jul 2016
REC opinion
Further Information Favourable Opinion