A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

-The subject is male or female; weighs =10 kg and is 2 to 17 years, inclusive, at the time of randomization with moderately to severely active UC or CD diagnosed at least 3 months prior to Screening by clinical and endoscopic evidence and corroborated by a histopathology report, and who have demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents: corticosteroids, immunomodulators, and/or TNF-a antagonist therapy.
-The subject has a medical history of moderately to severely active UC during Screening defined as a complete Mayo score of 6 to 12, and a total of Mayo subscores of stool frequency and rectal bleeding =4 and Mayo endoscopy subscore =2, or has moderately to severely active CD defined as simple endoscopic score for Crohn’s disease (SES-CD) =7, and the Crohn’s Disease Activity Index (CDAI) components of average daily Abdominal Pain Score of >1 for the 7 days prior, and total number of liquid/very soft stools >10 for the 7 days prior to the first dose of study drug.
-The subject has evidence of UC extending proximal to the rectum (ie, not limited to proctitis) or evidence of CD involving the ileum and/or colon, at a minimum.
-Subjects with extensive colitis or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months prior to their first dose of study drug.
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-The subject has had previous exposure to approved or investigational anti-integrins including, but not limited to, natalizumab, efalizumab, etrolizumab, or AMG 181, or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists, or rituximab.
-The subject has had prior exposure to vedolizumab.
-The subject has had hypersensitivity or allergies to any of the vedolizumab excipients.
-The subject has received:
a). any investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives prior to Screening (whichever is longer).
b). an approved biologic or biosimilar agent within 2 weeks prior to the first dose of the study drug or at any time during the Screening period.
-The subject has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
-The subject currently requires surgical intervention for UC or CD, or is anticipated to require surgical intervention for UC or CD during this study.
-The subject has other serious comorbidities that will limit his or her ability to complete the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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