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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03234907
Date of registration: 26/07/2017
Prospective Registration: Yes
Primary sponsor: Takeda
Public title: Vedolizumab Intravenous (IV) Compared to Placebo in Chinese Participants With Crohn's Disease
Scientific title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Crohn's Disease
Date of first enrolment: August 3, 2017
Target sample size: 215
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03234907
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
China
Contacts
Name:     Medical Director Clinical Science
Address: 
Telephone:
Email:
Affiliation:  Takeda
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Has a diagnosis of Crohn's disease (CD) established at least 3 months prior to
Screening by clinical and endoscopic evidence corroborated by a histopathology report.
Cases of CD established at least 6 months prior to randomization for which a
histopathology report is not available will be considered based on the weight of
evidence supporting the diagnosis and excluding other potential diagnoses, and must be
discussed with the sponsor on a case-by-case basis prior to randomization.

2. Has moderately to severely active CD as determined by a Crohn's Disease Activity Index
(CDAI) score of 220 to 400 within 7 days prior to the first dose of study drug and 1
of the following:

- C-reactive protein (CRP) level >2.87 mg/L during the Screening Phase, OR

- Ileocolonoscopy with photographic documentation of a minimum of 3 nonanastomotic
ulcerations (each >0.5 cm in diameter) or 10 aphtous ulcerations (involving a
minimum of 10 contiguous cm of intestine) consistent with CD, within 4 months
prior to randomization, OR

- Fecal calprotectin >250 µg/g stool during the Screening Phase 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), within 4 months prior to
Screening

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

4. 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 prior to initial screening (may be performed during
Screening if not performed in previous 12 months).

5. Has a family history of colorectal cancer, personal history of increased colorectal
cancer risk, age >50 years, or other known risk factor must be up-to-date on
colorectal cancer surveillance (may be performed during Screening).

6. Has demonstrated an inadequate response to, loss of response to, or intolerance of at
least 1 of the following agents as defined below:

- Corticosteroids.

- Immunomodulators.

- Tumor necrosis factor-alpha (TNF-a) antagonists.

Exclusion Criteria:

1. Has evidence of abdominal abscess at the initial Screening Visit.

2. Has had extensive colonic resection, subtotal or total colectomy.

3. Has a history of >3 small bowel resections or diagnosis of short bowel syndrome.

4. Has had ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, or
evidence of fixed stenosis, or small bowel stenosis with prestenotic dilation.

5. Has had previous exposure to approved or investigational anti-integrins (e.g.,
natalizumab, efalizumab, etrolizumab, or AMG-181), or MAdCAM-1 antagonists, or
rituximab.

6. Has used topical (rectal) treatment with 5-ASA, corticosteroid enemas/suppositories or
traditional Chinese medications for CD treatment within 2 weeks of the administration
of the first dose of study drug.

7. Requires currently or is anticipated to require surgical intervention for CD during
the study.

8. Has a history or evidence of adenomatous colonic polyps that have not been removed.

9. Has a history or evidence of colonic mucosal dysplasia including low or high-grade
dysplasia, as well as indeterminate for dysplasia.

10. Has a suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis,
ischemic colitis, and radiation colitis.

11. Has evidence of treatment for C.difficile infection or other intestinal pathogen with
28 days prior to first dose of study drug.

12. Has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV)
infection.

13. Has active or latent tuberculosis.

14. Has any identified congenital or acquired immunodeficiency (e.g., common variable
immunodeficiency, human immunodeficiency virus [HIV] infection, organ
transplantation).

15. Has any history of malignancy, except for the following: (a) adequately-treated
nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been
adequately treated and that has not recurred for at least 1 year prior to
randomization; and (c) history of cervical carcinoma in situ that has been adequately
treated and that has not recurred for at least 3 years prior to randomization.
Participants with remote history of malignancy (e.g., >10 years since completion of
curative therapy without recurrence) will be considered based on the nature of the
malignancy and the therapy received and must be discussed with the sponsor on a
case-by-case basis prior to randomization.

16. Has a history of any major neurological disorders, including stroke, multiple
sclerosis, brain tumor, or neurodegenerative disease.

17. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom
checklist at Screening or prior to the administration of the first dose of study drug
at Week 0.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: Placebo
Drug: Vedolizumab IV
Primary Outcome(s)
Percentage of Participants with Enhanced Clinical Response in the Induction Phase [Time Frame: Week 10]
Secondary Outcome(s)
Percentage of Participants with Clinical Remission in the Induction Phase [Time Frame: Week 10]
Secondary ID(s)
U1111-1195-3932
Vedolizumab-3034
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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