Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 126

Inclusion Criteria

-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).
-Noncutting seton placement as part of standard of care within 1 to 4 weeks prior to randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 107
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19

Exclusion Criteria

-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 or 5 half-lives of randomization (whichever is longer).
-Subjects who have had prior exposure to vedolizumab, natalizumab, efalizumab, or rituximab.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the proportion of subjects with fistula healing at Week 30 in 2 different dose regimens of vedolizumab IV 300mg in subjects with fistulizing CD.;Secondary Objective: The secondary objective is to evaluate fistula healing over a 30-week evaluation period.;Primary end point(s): The primary endpoint for this study is the proportion of subjects with a reduction of at least 50% from Day 1 in the number of draining fistulae at Week 30 (where closed fistulae are no longer draining despite gentle finger compression).;Timepoint(s) of evaluation of this end point: At week 30

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -The proportion of subjects with 100% fistulae closure at Week 30 (where all fistulae are no longer draining despite gentle finger compression).<br>-Time to first fistula closure.<br>-Time to last (100%) fistulae closure.<br>-Duration of fistula response (number of days with drainage);Timepoint(s) of evaluation of this end point: 30 week period

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