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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:  NCT02425111
Date of registration: 26/03/2015
Prospective Registration: Yes
Primary sponsor: Takeda
Public title: Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease
Scientific title: An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV
Date of first enrolment: March 30, 2015
Target sample size: 101
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02425111
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Belgium Canada Czech Republic Czechia France Hungary Italy Poland
United States
Contacts
Name:     Medical Director Clinical Science
Address: 
Telephone:
Email:
Affiliation:  Takeda
Key inclusion & exclusion criteria

Inclusion Criteria:

1. In the opinion of the investigator, the participant is capable of understanding and
complying with protocol requirements.

2. Signs and dates a written, informed consent form and any required privacy
authorization prior to the initiation of any study procedures.

3. Has a diagnosis of moderately to severely active Crohn's disease (CD) at least 3
months prior to enrollment, with a Crohn's Disease Activity Index (CDAI) score of
220-450 during the Screening Period, a simple endoscopic score for Crohn's Disease
(SES-CD) score of =7 and presence of at least one mucosal ulceration documented by
recorded ileocolonoscopy at Screening assessed by the central reader.

4. Has CD with involvement of the ileum and/or colon that can be assessed by
ileocolonoscopy.

5. Is male or female and aged 18 to 80 years, inclusive.

6. A male participant who is nonsterilized and sexually active with a female partner of
childbearing potential agrees to use adequate contraception from signing of informed
consent throughout the duration of the study and for 18 weeks after last dose.

7. A female participant of childbearing potential who is sexually active with a
nonsterilized male partner agrees to use routinely adequate contraception from signing
of informed consent throughout the duration of the study and for 18 weeks after last
dose.

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

- Immunomodulators:

i. Has signs and symptoms of persistently active disease despite a history of at
least one 12-week regimen of oral azathioprine (=1.5 mg/kg) or 6-mercaptopurine
(=0.75 mg/kg), OR ii. Has a history of intolerance (including but not limited to
nausea/vomiting, abdominal pain, pancreatitis, liver function test abnormalities,
lymphopenia, thiopurine S-methyltransferase non wild type [where wild type is
defined as thiopurine S-methyltransferase (TPMT)*1/*1], infection) to at least 1
immunomodulator.

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

i. Has signs and symptoms of persistently active disease despite a history of at
least 1 induction with:

1. Infliximab: 4-week regimen of 5 mg/kg, 2 doses at 2 weeks apart, OR

2. Adalimumab: 2-week regimen of 160 mg on Day 1 and 80 mg on Day 15, OR

3. Certolizumab: 4-week regimen of 400 mg initially at Weeks 0, 2, 4 OR ii. Has
recurrence of symptoms during maintenance dosing following prior clinical
benefit (discontinuation despite clinical benefit does not qualify), OR iii.
Has a history of intolerance of infliximab, adalimumab, or certolizumab,
including but not limited to, infusion-related reaction, demyelination,
congestive heart failure, or infection.

- Corticosteroids i. Signs and symptoms of persistently active disease despite a
history of at least one 4-week induction regimen that included a dose equivalent
to prednisone 30 mg daily orally for 2 weeks or intravenous(ly) (IV) for 1 week,
OR ii. Signs and symptoms of persistently active disease despite treatment with
budesonide 9 mg daily or 6 mg daily for maintenance, OR iii. At least one failed
attempt to taper corticosteroids to below a dose equivalent to prednisone 10 mg
daily orally, OR iv. History of intolerance to corticosteroids (including, but
not limited to, Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia,
insomnia, and infection).

9. May be receiving a stable therapeutic dose of conventional therapies for CD (excluding
other biologic agents 60 days before enrollment).

10. Has 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 (may be performed during Screening).

Exclusion Criteria:

1. Has received a diagnosis of ulcerative colitis or indeterminate colitis.

2. Has clinical evidence of abdominal abscess.

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

4. Has extensive colonic resection, ie, subtotal or total colectomy with <15 cm colon
remaining.

5. Has ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.

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

7. Has a history or evidence of colonic mucosal dysplasia.

8. Has intolerance or contraindication to undergo ileocolonoscopy.

9. Has active or latent tuberculosis, regardless of treatment history, as evidenced by
any of the following:

a. History of tuberculosis (TB). b. A diagnostic TB test performed during screening
that is positive, as defined by: i. A positive QuantiFERON® test or 2 successive
indeterminate QuantiFERON tests OR ii. A tuberculin skin test reaction =10 mm (=5 mm
in participants receiving the equivalent of >15 mg/day prednisone).

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

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

12. Has evidence of active C. difficile infection or is having treatment for C. difficile
infection or other intestinal pathogens during Screening.

13. Has evidence of an active infection during Screening.

14. Currently requires or has a planned surgical intervention for CD during the study.

15. Has received any investigational compound within 60 days of enrollment.

16. Has received any biologics within 60 days of enrollment.

17. Has received any live vaccinations within 30 days prior to enrollment.

18. Has conditions which, in the opinion of the investigator, may interfere with the
participant's ability to comply with the study procedures.

19. Has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal,
gastrointestinal (GI), genitourinary, hematological, coagulation, immunological,
endocrine/metabolic, or other medical disorder that, in the opinion of the
investigator, would confound the study results or compromise participant safety.

20. Has a history of hypersensitivity or allergies to vedolizumab or its components.

21. Has had prior exposure to vedolizumab, natalizumab, efalizumab, or rituximab.

22. Had a surgic



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: Vedolizumab
Primary Outcome(s)
Part A: Percentage of Participants Achieving Endoscopic Remission at Week 26 [Time Frame: Week 26]
Secondary Outcome(s)
Part A: Percentage of Participants Achieving Clinical Remission at Week 10 [Time Frame: Week 10]
Part A: Percentage of Participants Achieving Clinical Remission at Week 26 [Time Frame: Week 26]
Part A: Percentage of Participants Achieving Clinical Response at Week 10 [Time Frame: Baseline and Week 10]
Part A: Percentage of Participants Achieving Clinical Response at Week 26 [Time Frame: Baseline and Week 26]
Part A: Percentage of Participants Achieving Complete Mucosal Healing at Week 26 [Time Frame: Week 26]
Part A: Percentage of Participants Achieving Endoscopic Remission at Week 14 [Time Frame: Week 14]
Part A: Percentage of Participants With Endoscopic Response at Week 14 [Time Frame: Baseline and Week 14]
Part A: Percentage of Participants With Endoscopic Response at Week 26 [Time Frame: Baseline and Week 26]
Part B: Percentage of Participants Achieving Clinical Remission at Week 52 [Time Frame: Week 52]
Part B: Percentage of Participants Achieving Clinical Response at Week 52 [Time Frame: Baseline and Week 52]
Part B: Percentage of Participants Achieving Complete Mucosal Healing at Week 52 [Time Frame: Week 52]
Part B: Percentage of Participants Achieving Endoscopic Remission at Week 52 [Time Frame: Week 52]
Part B: Percentage of Participants With Durable Clinical Remission [Time Frame: Weeks 26 and 52]
Part B: Percentage of Participants With Endoscopic Response at Week 52 [Time Frame: Baseline and Week 52]
Secondary ID(s)
183974
2014-003509-13
MLN0002-3028
U1111-1159-5806
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 14/09/2018
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02425111
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