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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 1 February 2020
Main ID:  EUCTR2017-002231-41-PL
Date of registration: 13/10/2017
Prospective Registration: Yes
Primary sponsor: Takeda Development Centre Europe, Ltd.
Public title: A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease
Scientific title: 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
Date of first enrolment: 17/01/2018
Target sample size: 80
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002231-41
Study type:  Interventional clinical trial of medicinal product
Study design: 
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Vedolizumab to be tested at doses of 300mg, 200mg, 150 mg and 100mg
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Belgium Canada France Germany Hungary Israel Netherlands Poland
Ukraine United Kingdom United States
Contacts
Name: Takeda Study Registration Call Cent   
Address:  Unknown Unknown Unknown United States
Telephone: +1877825-3327
Email: medicalinformation@tpna.com
Affiliation:  Takeda
Name: Takeda Study Registration Call Cent   
Address:  Unknown Unknown Unknown United States
Telephone: +1877825-3327
Email: medicalinformation@tpna.com
Affiliation:  Takeda
Key inclusion & exclusion 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 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Ulcerative Colitis and Crohn’s Disease
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Intervention(s)

Trade Name: Entyvio
Product Name: Vedolizumab IV
Product Code: MLN0002
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)

Primary end point(s): - PK parameters - area under the serum concentration-time curve at Week 14 (AUC Wk 14).
- Average serum concentration during a dosing interval at Week 14 (Cav, Wk 14).
- Observed serum concentration at the end of a dosing interval at Week 14 (Ctrough, Wk 14)


Secondary Objective: - To assess the efficacy of vedolizumab IV in pediatric subjects with UC or CD.
- To characterize the dose-response relationships of vedolizumab IV in pediatric subjects with UC or CD.
Main Objective: - To evaluate vedolizumab PK in pediatric subjects with UC or CD.
Timepoint(s) of evaluation of this end point: Week 14
Secondary Outcome(s)

Secondary end point(s): 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 as defined by a =70 point decrease from baseline in CDAI score at Week 14.
Timepoint(s) of evaluation of this end point: Week 14
Secondary ID(s)
009125
2017-002231-41-GB
MLN0002-2003
Source(s) of Monetary Support
Takeda Development Centre Europe, Ltd.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 02/11/2017
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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