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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 2019
Main ID:  EUCTR2015-000481-58-SK
Date of registration: 05/01/2016
Prospective Registration: Yes
Primary sponsor: Takeda Development Centre Europe, Ltd.
Public title: Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease
Scientific title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy - Efficacy and Safety of Vedolizumab SC as Maintenance Therapy in Crohn’s Disease
Date of first enrolment: 22/01/2016
Target sample size: 824
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000481-58
Study type:  Interventional clinical trial of medicinal product
Study design: 
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
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): yes Therapeutic use (Phase IV): no
Countries of recruitment
Argentina Australia Belgium Bosnia and Herzegovina Brazil Bulgaria Canada Czech Republic
Denmark Estonia Germany Hungary Israel Italy Japan Korea, Republic of
Lithuania Mexico Netherlands Poland Romania Russian Federation Serbia Slovakia
South Africa Spain Sweden Taiwan Turkey Ukraine 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:
1. The subject has a diagnosis of Crohn's disease (CD) established at least 3 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.
2. The subject has moderately to severely active CD.
3. The subject has CD involvement of the ileum and/or colon, at a minimum.
4. The subject has extensive colitis or pancolitis of >8 years duration or limited colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit.
5. Subjects with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factors must be up-to-date on colorectal cancer surveillance at screening.
6. The subject has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents: immunomodulators, corticosteroids, or TNF-alpha antagonists.
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 799
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion criteria:
1. The subject has evidence of abdominal abscess at the initial Screening Visit.
2. The subject has had extensive colonic resection, subtotal or total colectomy.
3. The subject has a history of >3 small bowel resections or diagnosis of short bowel syndrome.
4. The subject has received tube feeding, defined formula diets, or parenteral alimentation within 28 days prior to the administration of the first dose of study drug.
5. The subject has ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
6. The subject has received any of the investigational or approved non-biologic therapies (eg, cyclosporine, tacrolimus, thalidomide, methotrexate, or tofacitinib except for those specifically listed in the protocol) for the treatment of underlying disease within 30 days or 5 half-lives of screening (which ever is longer).
7. The subject has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (which ever is longer).
8. The subject has used topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks of the administration of the first dose of study drug.
9. The subject requires currently or is anticipated to require surgical intervention for CD during the study.
10. The subject has a history or evidence of adenomatous colonic polyps that have not been removed.
11. The subject has a history or evidence of colonic mucosal dysplasia.
12. The subject has a suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
13. The subject has evidence of an active infection during the Screening Period.
14. The subject has evidence of, or treatment for, C. difficile infection or other intestinal pathogen with 28 days prior to first dose of study drug.
15. The subject has chronic hepatitis B virus (HBV) infection* or chronic hepatitis C virus (HCV) infection.
* HBV immune subjects (ie, being hepatitis B surface antigen [HBsAg] negative and hepatitis B surface antibody [HBsAb] positive) may, however, be included.
16. The subject has active or latent TB as evidenced by the following:
i. A positive diagnostic TB test within 30 days prior to screening or during the screening period, defined as: 1. A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, (or, A positive T-SPOT TB test [Japan only]), OR,
Vedolizumab SC 2. A tuberculin skin test reaction =5 mm.
Note: if subjects have received BCG vaccine then a QuantiFERON TB Gold text should be performed instead of the tuberculin skin text
ii. Chest X-ray within 3 months prior to Week 0 which is suspicious for pulmonary TB, and a positive or 2 successive indeterminate QuantiFERON tests (or, A positive T-SPOT TB test [Japan only]) within 30 days prior to Screening or during the Screening Period.
Note: subjects with documented previously treated TB with a negative QuantiFERON text can be included in the study.
17. The subject has any identified congenital or acquired immunodefici


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: 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-

Product Name: Vedolizumab SC
Product Code: MLN0002 SC
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Vedolizumab SC
CAS Number: 943609-66-3
Current Sponsor code: MLN0002 SC
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 108-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: • To determine the effect of vedolizumab SC maintenance treatment on enhanced clinical response at Week 52 in subjects who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2.
• To determine the effect of vedolizumab SC maintenance treatment on corticosteroid-free remission at Week 52 in subjects who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2.
• To assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects who are naïve to TNF-alpha antagonist exposure, and achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2.
Main Objective: • To assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects with moderately to severely active Crohn's disease who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2.
Primary end point(s): • Proportion of subjects with clinical remission, defined as Crohn’s Disease Activity Index (CDAI) score =150, at Week 52.
Timepoint(s) of evaluation of this end point: Week 52
Secondary Outcome(s)

Secondary end point(s): • Proportion of subjects with enhanced clinical response, defined as a =100 point decrease in CDAI score from Baseline (Week 0), at Week 52.
• Proportion of subjects with corticosteroid-free remission, defined as subjects using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52.
• Proportion of TNF-alpha antagonist naïve subjects who achieved clinical remission, defined as CDAI score =150, at Week 52.
Timepoint(s) of evaluation of this end point: Week 52
Secondary ID(s)
MLN0002SC-3031
NCT02611817
Source(s) of Monetary Support
Takeda Development Center Americas, Inc
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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