A Randomized DoubleBlind 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)
- Conditions
- Crohn Diseaseinflamatory bowel disease10017969
- Registration Number
- NL-OMON45760
- Lead Sponsor
- Takeda Development Centre Europe, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Adult subjects, aged 18 to 80 years, inclusive, with moderately to severely active CD and 1 to 3 draining perianal fistula(e) of at least 2 weeks duration.
Subjects who have historically had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-a antagonist for their underlying CD (does not require treatment failure for currently active draining fistula); for subjects from France only: subjects who have historically failed (ie, had an inadequate response with, lost response to, or was intolerant to) infliximab for treatment of their underlying CD or fistulizing CD.
Subjects who have perianal abscesses greater than 2 cm or an abscess that the investigator feels requires drainage based on either clinical assessment or MRI.
Subjects who have a CDAI score greater than 400.
Subjects who have ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
Subjects who have significant anal or rectal stenosis.
Subjects who have any evidence of an active infection (eg, sepsis, cytomegalovirus, or listeriosis) during screening, other than related to the fistula(e).
Subjects who have a positive progressive multifocal leukoencephalopathy (PML) subjective checklist.
Subjects who have received any investigational or approved biologic or biosimilar agent within 60 days of randomization.
Subjects who have had prior exposure to vedolizumab, natalizumab, efalizumab, rituximab, etrolizumab, or antimucosal addressin cell adhesion molecule-1 (MAdCAM-1) therapy.
Subjects who have active or latent tuberculosis.
Subjects who have a known history of hepatitis B virus (HBV), hepatitis C virus (HCV), acquired human immunodeficiency virus (HIV), or are found to be seropositive at Screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint for this study is the proportion of subjects with a<br /><br>reduction of at least 50% from Day 1 in number of draining perianal fistulae at<br /><br>Week 30 (where closed fistulae are no longer draining despite gentle finger<br /><br>compression).</p><br>
- Secondary Outcome Measures
Name Time Method <p>- The proportion of subjects with a reduction of at least 50% from Day 1 in the<br /><br>number of draining perianal fistulae at both Week 22 and Week 30 (where closed<br /><br>fistulae are no longer draining despite gentle finger compression).<br /><br>-The proportion of subjects with 100% perianal fistulae closure at Week 30<br /><br>(where all fistulae are no longer draining despite gentle finger compression).<br /><br>-Time to first perianal fistula closure.<br /><br>-Time to last (100%) perianal fistulae closure.<br /><br>-Duration of perianal fistula response (eg, number of days with drainage).</p><br>