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

• Register: EUCTR
• Last refreshed on: 22 June 2020
• Main ID: EUCTR2017-002231-41-BE
• Date of registration: 14/09/2017
• 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: 10/01/2018
• Target sample size: 80
• Recruitment status: Not Recruiting
• 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
• Affiliation: Takeda

• Name: Takeda Study Registration Call Cent
• 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 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

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-

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: 150-

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: 200-

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: 100-

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)

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.
- To characterize the dose-response relationships of vedolizumab IV 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)

MLN0002-2003

009125

2017-002231-41-GB

Source(s) of Monetary Support

Takeda Development Centre Europe, Ltd.

Ethics review

Status: Approved
Approval date: 10/01/2018
Contact: