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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: 28 February 2019
Main ID:  EUCTR2015-000852-12-ES
Date of registration: 20/07/2016
Prospective Registration: Yes
Primary sponsor: Takeda Development Centre Europe, Ltd.
Public title: NCT02630966
Scientific title: 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 SUMMARY The drug being tested in this study is called vedolizumab IV [intravenous(ly)]). Vedolizumab IV is being tested to treat people who have fistulizing Crohn's disease (CD). This study will look at fistula healing in people who take vedolizumab IV. The study will enroll approximately 126 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups?which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): *Group 1: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 14 and 22, and a placebo infusion at Week 10 (dummy inactive infusion - this is a solution that looks like the study drug but has no active ingredient). *Group 2: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 10, 14 and 22. This multi-center trial will be conducted worldwide. The overall time to participate in this study from screening to 18 weeks after the last dose is 43 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment. - ENTERPRISE
Date of first enrolment: 20/07/2016
Target sample size: 126
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: +44203116 8000
Email: clinicaloperations@tgrd.com
Affiliation:  Takeda Development Centre Europe, Ltd.
Name: Study Manager   
Address:  61 Aldwych WC2B 4AE London United Kingdom
Telephone: +44203116 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 TNF-alfa antagonist for their underlying CD (does not require treatment failure for currently active draining fistula).
-Noncutting seton placement as part of standard of care within 1 to 4 weeks prior to randomization.
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 107
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19

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 or 5 half-lives of randomization (whichever is longer).
-Subjects who have had prior exposure to vedolizumab, natalizumab, efalizumab, or rituximab.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Fistulizing Crohn?s Disease (CD)
MedDRA version: 19.0 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 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
Vedolizumab-4003
Source(s) of Monetary Support
Takeda Development Centre Europe, Ltd.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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