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(A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble

Takeda Development Centre Europe, Ltd.0 sites80 target enrollmentSeptember 11, 2017

Conditionslcerative Colitis and Crohn’s Disease MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

DrugsEntyvio

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: lcerative Colitis and Crohn’s Disease
Sponsor: Takeda Development Centre Europe, Ltd.
Enrollment: 80
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 11, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Takeda Development Centre Europe, Ltd.

Eligibility Criteria

Inclusion Criteria

•\-The subject is male or female; weighs \=10 kg and 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 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.