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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: 20 July 2020
Main ID:  EUCTR2015-000852-12-GB
Date of registration: 30/03/2016
Prospective Registration: Yes
Primary sponsor: Takeda Development Centre Europe, Ltd.
Public title: Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease
Scientific title: A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn’s Disease - ENTERPRISE
Date of first enrolment: 07/07/2016
Target sample size: 100
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000852-12
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: yes
Other: no
Number of treatment arms in the trial: 2
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Belgium Canada France Italy Netherlands Spain United Kingdom United States
Contacts
Name: Study Manager   
Address:  61 Aldwych WC2B 4AE London United Kingdom
Telephone: +4420 3116 8000
Email: clinicaloperations@tgrd.com
Affiliation:  Takeda Development Centre Europe, Ltd.
Name: Study Manager   
Address:  61 Aldwych WC2B 4AE London United Kingdom
Telephone: +4420 3116 8000
Email: clinicaloperations@tgrd.com
Affiliation:  Takeda Development Centre Europe, Ltd.
Key inclusion & exclusion criteria
Inclusion criteria:
-Adult subjects, aged 18 to 80 years, inclusive, with moderately to severely active CD and 1 to 3 draining perianal fistula(e) of at least 2 weeks duration.
-Subjects who have historically had an inadequate response with, lost
response to, or were intolerant to either conventional therapy or a TNFalpha antagonist for their underlying CD (does not require treatment failure for currently active draining fistula); for subjects from France only: subjects who have historically failed (ie, had an inadequate response with, lost response to, or was intolerant to) infliximab for treatment of their underlying CD or fistulizing CD.
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 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion criteria:
-Subjects who have perianal abscesses greater than 2 cm or an abscess that the investigator feels requires drainage based on either clinical assessment or MRI.
-Subjects who have a CDAI score greater than 400.
-Subjects who have ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
-Subjects who have significant anal or rectal stenosis.
-Subjects who have any evidence of an active infection (eg, sepsis, cytomegalovirus, or listeriosis) during Screening, other than related to the fistula(e).
-Subjects who have a positive progressive multifocal leukoencephalopathy (PML) subjective checklist.
-Subjects who have received any investigational or approved biologic or biosimilar agent within 60 days of randomization.
-Subjects who have had prior exposure to vedolizumab, natalizumab, efalizumab, or rituximab, etrolizumab, or anti- mucosal addressin cell adhesion molecule-1 (MAdCAM-1) therapy.
-Subjects who have active or latent tuberculosis.
-Subjects who have a known history of hepatitis B virus (HBV), hepatitis
C virus (HCV), acquired human immunodeficiency virus (HIV), or are
found to be seropositive at Screening.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Fistulizing Crohn’s Disease (CD)
MedDRA version: 20.0 Level: LLT Classification code 10075465 Term: Fistulizing Crohn's disease System Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Trade Name: Entyvio
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: vedolizumab
CAS Number: 943609-66-3
Current Sponsor code: MLN0002
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: The primary objective is to evaluate the proportion of subjects with fistula healing at Week 30 in 2 different dose regimens of vedolizumab IV 300mg in subjects with fistulizing CD.
Primary end point(s): The primary endpoint for this study is the proportion of subjects with a reduction of at least 50% from Day 1 in the number of draining fistulae at Week 30 (where closed fistulae are no longer draining despite gentle finger compression).
Secondary Objective: The secondary objective is to evaluate fistula healing over a 30-week evaluation period.
Timepoint(s) of evaluation of this end point: At week 30
Secondary Outcome(s)
Secondary end point(s): -The proportion of subjects with a reduction of at least 50% from Day 1
in the number of draining perianal fistulae at both Week 22 and Week 30
(where closed fistulae are no longer draining despite gentle finger compression).
-The proportion of subjects with 100% fistulae closure at Week 30 (where all fistulae are no longer draining despite gentle finger compression).
-Time to first fistula closure.
-Time to last (100%) fistulae closure.
-Duration of fistula response (number of days with drainage)
Timepoint(s) of evaluation of this end point: 30 week period
Secondary ID(s)
2015-000852-12-BE
NCT02630966
Vedolizumab-4003
Source(s) of Monetary Support
Takeda Development Centre Europe, Ltd.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 07/07/2016
Contact:
Results
Results available: Yes
Date Posted: 27/11/2019
Date Completed: 14/11/2018
URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-000852-12/results
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