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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: 30 April 2018
Main ID:  EUCTR2014-003509-13-CZ
Date of registration: 27/04/2015
Prospective Registration: Yes
Primary sponsor: Takeda Development Centre Europe Ltd
Public title: Effect of Vedolizumab IV in subjects with Crohn's Disease
Scientific title: An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV - Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease
Date of first enrolment: 25/06/2015
Target sample size: 100
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003509-13
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Belgium Canada Czech Republic Hungary Poland United States
Contacts
Name: Study Manager   
Address:  61 Aldwych WC2B 4AE London United Kingdom
Telephone: 442031168000
Email: clinicaloperations@tgrd.com
Affiliation:  Takeda Development Centre Europe Ltd
Name: Study Manager   
Address:  61 Aldwych WC2B 4AE London United Kingdom
Telephone: 442031168000
Email: clinicaloperations@tgrd.com
Affiliation:  Takeda Development Centre Europe Ltd
Key inclusion & exclusion criteria
Inclusion criteria:
- The subject has a diagnosis of moderately to severely active CD at least 3 months prior to enrollment, with a CDAI score of 220-450 during the Screening Period, a SES-CD score of =7 and presence of at least one mucosal ulceration documented by recorded ileocolonoscopy at Screening assessed by the central reader.
- The subject has CD with involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.
- The subject has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
? Immunomodulators:
i. The subject has signs and symptoms of persistently active disease despite a history of at least one 12-week regimen of oral azathioprine (=1.5 mg/kg) or
6-mercaptopurine (=0.75 mg/kg), OR
ii. The subject has a history of intolerance (including but not limited to nausea/ vomiting, abdominal pain, pancreatitis, liver function test abnormalities, lymphopenia, thiopurine S-methyltransferase non wild type [where wild type is
defined as TPMT*1/*1], infection) to at least 1 immunomodulator.
? TNF-? antagonists:
i. The subject has signs and symptoms of persistently active disease despite a history of at least 1 induction with:
a) Infliximab: 4-week regimen of 5 mg/kg, 2 doses at 2 weeks apart, OR
b) Adalimumab: 2-week regimen of 160 mg on Day 1 and 80 mg on Day 15, OR
c) Certolizumab: 4-week regimen of 400 mg initially at Weeks 0, 2, 4 OR
ii. The subject has recurrence of symptoms during maintenance dosing following
prior clinical benefit (discontinuation despite clinical benefit does not qualify), OR
iii. The subject has a history of intolerance of infliximab, adalimumab, or
certolizumab, including but not limited to, infusion-related reaction,
demyelination, congestive heart failure, or infection.
? Corticosteroids
i. Signs and symptoms of persistently active disease despite a history of at least one
4-week induction regimen that included a dose equivalent to prednisone 30 mg
daily orally for 2 weeks or IV for 1 week, OR
ii. Signs and symptoms of persistently active disease despite treatment with
budesonide 9 mg daily or 6 mg daily for maintenance, OR
iii. At least one failed attempt to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally, OR
iv. History of intolerance to corticosteroids (including, but not limited to, Cushing’s
syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, and infection).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion criteria:
- The subject has active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following:
a) History of TB.
b) A diagnostic TB test performed during screening that is positive, as defined by:
i. A positive QuantiFERON® test or 2 successive indeterminate QuantiFERON tests OR
ii. A tuberculin skin test reaction =10 mm (=5 mm in patients receiving the equivalent of >15 mg/day prednisone)
- The subject has chronic hepatitis B (HBV) or hepatitis C (HCV) infection.
- The subject has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
- The subject has evidence of active C. difficile infection or is having treatment for C. difficile infection or other intestinal pathogens during Screening.
- The subject has evidence of an active infection during Screening.
- The subject has received any investigational compound within 60 days of enrollment.
- The subject has received any biologics within 60 days of enrollment.
- The subject has received any live vaccinations within 30 days prior to enrollment.
- The subject has a positive PML subjective symptom checklist during screening and prior to the administration of study drug on Day 1.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Crohn's Disease
MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: Vedolizumab IV (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
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)
Main Objective: To evaluate endoscopic remission at Week 26 as assessed by ileocolonoscopy.
Primary end point(s): The primary endpoint is the proportion of subjects achieving endoscopic remission, defined as a simple endoscopic score for Crohn’s Disease (SES-CD) score of = 4 at Week 26.
Secondary Objective: ? Part A
• To examine the relationship among endoscopic, imaging, histological, and clinical assessments of CD.
• To evaluate endoscopic remission at Week 14.
• To evaluate endoscopic response at Weeks 14 and 26.
• To evaluate clinical response assessed by Crohn’s Disease Activity Index (CDAI) at Weeks 10 and 26.
• To evaluate clinical remission assessed by CDAI at Weeks 10 and 26.
Part B
• To examine the relationship among endoscopic, imaging, histological, and clinical assessments of CD.
• To evaluate endoscopic remission at Week 52.
• To evaluate endoscopic response at Week 52.
• To evaluate clinical response assessed by Crohn’s Disease Activity Index (CDAI) at Week 52.
• To evaluate clinical remission assessed by CDAI at Weeks 52
• To evaluate durable endoscopic remission at Week 52 in subjects with endoscopic remission at Week 26.
Timepoint(s) of evaluation of this end point: Week 26
Secondary Outcome(s)
Secondary end point(s): -The secondary endpoints for this studyPart A are:
• Proportion of subjects achieving complete mucosal healing (defined as absence of ulceration) at Week 26.
• Proportion of subjects achieving endoscopic remission at Week 14.
• Proportion of subjects with endoscopic response (defined as SES-CD reduction by =50%) at Week 14.
• Proportion of subjects with endoscopic response (defined as SES-CD reduction by =50%) at Week 26.
• Proportion of subjects achieving clinical response (CDAI decrease from Baseline of =100 points) at Week 10.
• Proportion of subjects achieving clinical response (CDAI decrease from Baseline of =100 points) at Week 26.
• Proportion of subjects achieving clinical remission (CDAI =150) at Week 10.
• Proportion of subjects achieving clinical remission (CDAI =150) at Week 26.

The secondary endpoints for Part B are:
• Proportion of subjects achieving complete mucosal healing (defined as absence of ulceration) at Week 52.
• Proportion of subjects achieving endoscopic remission at Week 52.
• Proportion of subjects with endoscopic response (defined as SES-CD reduction by =50%) at Week 52.
• Proportion of subjects achieving clinical response (CDAI decrease from Baseline of =100 points) at Week 52.
• Proportion of subjects achieving clinical remission (CDAI =150) at Week 52.
• Proportion of subjects with durable clinical remission, defined as clinical remission at Week 26 and Week 52.
Timepoint(s) of evaluation of this end point: Week 10, 14 , 26 and 52
Secondary ID(s)
2014-003509-13-HU
MLN0002-3028
Source(s) of Monetary Support
Takeda Development Center Americas, Inc
Takeda Development Centre Europe Ltd
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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