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

Phase 1

Conditions: lcerative 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]

Registration Number: EUCTR2017-002231-41-FR

Lead Sponsor: Takeda Development Centre Europe, Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

-The subject is male or female 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 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 (eg, 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 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).
-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
Main Objective: - To evaluate vedolizumab PK in pediatric subjects with UC or CD.;Secondary Objective: - To assess the efficacy of vedolizumab IV in pediatric subjects with UC or CD.<br>- To characterize the dose-response relationships of vedolizumab IV in pediatric subjects with UC or CD.;Primary end point(s): - PK parameters - area under the serum concentration-time curve at Week 14 (AUC Wk 14).<br>- Average serum concentration during a dosing interval at Week 14 (Cav, Wk 14).<br>- Observed serum concentration at the end of a dosing interval at Week 14 (Ctrough, Wk 14)<br><br>;Timepoint(s) of evaluation of this end point: Week 14

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints for this study are:<br>-Percentage of UC subjects who achieve clinical response based on complete Mayo score at Week 14.<br>-Percentage of CD subjects who achieve clinical response based on CDAI at Week 14.;Timepoint(s) of evaluation of this end point: Week 14

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