A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn*s Disease.<br>(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn*s Disease).
- Conditions
- Ulcerative Colitis (UC)Crohn's Disease (CD)10017969
- Registration Number
- NL-OMON46400
- Lead Sponsor
- Takeda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 8
-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.
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints for this study are PK parameters at Week 14 (area under<br /><br>the serum concentration-time curve at Week 14 [AUCWk 14], average serum<br /><br>concentration during a dosing interval at Week 14 [Cav,Wk 14], and observed<br /><br>serum concentration at the end of Week 14 [Ctrough,Wk 14]).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints for this study are:<br /><br>* Percentage of UC subjects who achieve clinical response based on complete<br /><br>Mayo score at Week 14.<br /><br>* Percentage of CD subjects who achieve clinical response based on CDAI at Week<br /><br>14.</p><br>