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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.
Last refreshed on: 12 December 2020
Main ID:  NCT02611817
Date of registration: 19/11/2015
Prospective Registration: Yes
Primary sponsor: Takeda
Public title: Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
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
Date of first enrolment: January 4, 2016
Target sample size: 644
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Argentina Australia Belgium Bosnia and Herzegovina Brazil Bulgaria Canada Czech Republic
Czechia 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
Name:     Medical Director Clinical Science
Affiliation:  Takeda
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of CD established at least 3 months prior to screening by clinical and
endoscopic evidence corroborated by a histopathology report.

2. Moderately to severely active CD as determined by a CDAI score of 220 to 450 and 1 of
the following:

- C-reactive protein (CRP) level greater than (>) 2.87 milligram per liter (mg/L)

- Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic
ulcerations (each >0.5 centimeter [cm] in diameter) or 10 aphthous ulcerations
(involving a minimum of 10 contiguous cm of intestine) consistent with CD OR

- Fecal calprotectin >250 microgram per gram (mcg/g) stool during the screening
period in conjunction with computed tomography enterography (CTE), magnetic
resonance enterography (MRE), contrast-enhanced small bowel radiography, or
wireless capsule endoscopy revealing CD ulcerations (aphthae not sufficient).

3. CD involvement of the ileum and/or colon, at a minimum.

4. Inadequate response with, loss of response to, or intolerance to corticosteroids,
immunomodulators, or Tumor necrosis factor-alpha (TNF-a) antagonists.

Exclusion Criteria:

1. Evidence of abdominal abscess at Screening.

2. Extensive colonic resection, subtotal or total colectomy.

3. History of >3 small bowel resections or diagnosis of short bowel syndrome.

4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.

5. Prior exposure to investigational or approved non-biologic therapies (example,
cyclosporine, tacrolimus, thalidomide, or tofacitinib) for the treatment of underlying
disease within 30 days or 5 half-lives of screening (whichever is longer).

6. Prior exposure to any investigational or approved biologic or biosimilar agent within
60 days or 5 half-lives of screening (whichever is longer).

7. Prior exposure to vedolizumab.

8. Surgical intervention for CD required at any time during the study.

9. History or evidence of adenomatous colonic polyps that have not been removed, or of
colonic mucosal dysplasia.

10. Suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis,
ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or
microscopic colitis.

11. Active infections.

12. Chronic hepatitis B virus (HBV) or C (HCV) infection, tuberculosis (TB) (active or
latent), or congenital or acquired immunodeficiency. HBV immune participants (that is,
being hepatitis B surface antigen [HBsAg] negative and hepatitis B antibody positive)
may, however, be included.

13. History of any major neurological disorders, including stroke, multiple sclerosis,
brain tumor, or neurodegenerative disease.

Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Drug: Placebo
Drug: Vedolizumab IV 300 mg
Drug: Vedolizumab SC 108 mg
Primary Outcome(s)
Percentage of Participants Achieving Clinical Remission at Week 52 [Time Frame: Week 52]
Secondary Outcome(s)
Percentage of Participants Achieving Corticosteroid-free Remission at Week 52 [Time Frame: Week 52]
Percentage of Participants Achieving Enhanced Clinical Response at Week 52 [Time Frame: Week 52]
Percentage of TNF-alpha Antagonist Naive Participants Achieving Clinical Remission at Week 52 [Time Frame: Week 52]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available: Yes
Date Posted: 23/06/2020
Date Completed:
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