Ulcerative Colitis (UC)
Conditions
Interventions
Subjects weighing *30 kg prior to first dose in the study will be randomly
assigned to receive 300 mg (high dose) or 150 mg (low dose) vedolizumab IV.
Subjects weighing
Crohn's Disease (CD)
Ulcerative Colitis (UC)
Sponsors
Takeda
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: -The subject is male or female; weighs *10kg 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-* 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.
Exclusion criteria
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 or approved biologic or biosimilar agent (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints for this study are PK parameters at Week 14 (area under the serum concentration-time curve at Week 14 [AUCWk 14], average serum concentration during a dosing interval at Week 14 [Cav,Wk 14], and observed serum concentration at the end of Week 14 [Ctrough,Wk 14]). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints for this study are: * Percentage of UC subjects who achieve clinical response based on complete Mayo score at Week 14. * Percentage of CD subjects who achieve clinical response based on CDAI at Week 14. | — |
Countries
Belgium, Canada, France, Germany, Hungary, Israel, Netherlands, Poland, Ukraine, United Kingdom, United States of America
Outcome results
None listed