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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: 3 October 2016
Main ID:  NCT02913508
Date of registration: 22/09/2016
Prospective Registration: No
Primary sponsor: Takeda
Public title: Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's Disease
Scientific title: A Randomized, Open Label Phase 2 Study to Assess Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Exploratory Efficacy of Vedolizumab Subcutaneous Compared to Vedolizumab Intravenous in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
Date of first enrolment: April 2014
Target sample size: 0
Recruitment status: Withdrawn
URL:  https://clinicaltrials.gov/show/NCT02913508
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Contacts
Name:     Medical Director Clinical Science
Address: 
Telephone:
Email:
Affiliation:  Takeda
Key inclusion & exclusion criteria

Inclusion Criteria:

General Inclusion Criteria

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

2. The participant or, when applicable, the participant's legally acceptable
representative signs and dates a written, informed consent form and any required
privacy authorization prior to the initiation of any study procedure.

3. Is aged 18 to 80 years, inclusive.

4. The male or female participant is voluntarily able to give informed consent.

5. 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.

6. 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.

Inclusion Criteria for Ulcerative Colitis Participants

7. Has a diagnosis of ulcerative colitis (UC) established at least 3 months prior to
randomization by clinical and endoscopic evidence and corroborated by a
histopathology report.

8. Has moderately to severely active UC as determined by a partial Mayo score of 3 to 9
within 7 days prior to the first dose of study drug.

9. Has evidence of UC extending proximal to the rectum (=15 cm of involved colon).

10. Participants with extensive colitis or pancolitis of >8 years duration or left-sided
colitis of >12 years duration must have documented evidence that a surveillance
colonoscopy with random and targeted biopsies was performed within 18 months of the
initial screening visit (may be performed during screening).

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

12. Participants may be receiving a therapeutic dose of the following drugs:

1. Oral or topical (rectal) 5-aminosalicylate (5-ASA) compounds provided that the
dose has been stable for the 2 weeks immediately prior to randomization;

2. Oral corticosteroid therapy (prednisone at a stable dose =30 mg/day, budesonide
at a dose =9 mg/day or equivalent steroid) provided that the dose has been
stable for the 4 weeks immediately prior to randomization if corticosteroids
have just been initiated, or for the 2 weeks immediately prior to randomization
if corticosteroids are being tapered;

3. Topical (rectal) corticosteroid enemas/suppositories;

4. Azathioprine or 6-mercaptopurin provided that the dose has been stable for the 8
weeks immediately prior to randomization;

5. Antidiarrheals (eg, loperamide, diphenoxylate with atropine) for control of
chronic diarrhea;

6. Probiotics (eg, Culturelle, S. boulardii) provided that the dose has been stable
for the 2 weeks immediately prior to randomization;

7. Antibiotics used for the treatment of inflammatory bowel disease (IBD) (ie,
ciprofloxacin, metronidazole).

Inclusion Criteria for Crohn's Disease Participants

13. Has a diagnosis of Crohn's Disease (CD) established at least 3 months prior to
randomization by clinical and endoscopic evidence and corroborated by a
histopathology report. Cases of CD established at least 3 months prior to
randomization for which a histopathology report is not available will be considered
based on the weight of the 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.

14. Has moderately to severely active CD as determined by Crohn's Disease Activity Index
(CDAI) score of 220 to 450 within 7 days prior to the first dose of study drug and 1
of the following:

1. C-reactive protein (CRP) level >2.87 mg/L during the Screening Period, OR;

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

3. Fecal calprotectin >250 mcg/g stool during the Screening Period in conjunction
with Computed Tomography (CT) enterography, magnetic resonance (MR)
enterography, contrast-enhanced small bowel radiography, or wireless capsule
endoscopy revealing Crohn's ulcerations (aphthae not sufficient), within 4
months prior to screening (participants with evidence of fixed stenosis or small
bowel stenosis with prestenotic dilation should not be included).

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

16. Participants with extensive colitis or pancolitis of >8 years duration or limited
colitis of >12 years duration must have documented evidence that a surveillance
colonoscopy with random and targeted biopsies was performed within 18 months of
randomization (may be performed during screening).

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

18. Participants may be receiving a therapeutic dose of the following drugs:

1. Oral or topical (rectal) 5-ASA compounds provided that the dose has been stable
for the 2 weeks immediately prior to randomization;

2. Oral corticosteroid therapy (prednisone at a stable dose =30 mg/day, budesonide
at a dose =9 mg/day, or equivalent steroid) provided that the dose has been
stable for the 4 weeks immediately prior to randomization if corticosteroids
have just been initiated, or for the 2 weeks immediately prior to randomization
if corticosteroids are being tapered;

3. Topical (rectal) corticosteroid enemas/suppositories;

4. Antibiotics used for the treatment of IBD (ie, ciprofloxacin, metronidazole);

5. Azathioprine or 6-mercaptopurin provided that the dose has been stable for the 8
weeks immediately prior to randomization;




Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Ulcerative Colitis
Intervention(s)
Drug: Vedolizumab intravenous injection
Drug: Vedolizumab subcutaneous injection
Primary Outcome(s)
Average Concentration of Vedolizumab Over the Dosing Interval at Steady-State (Cavg, ss) [Time Frame: Week 0 up to Week 22]
Average Concentration of Vedolizumab Over the Dosing Interval from Week 0 to Week 6 (Cavg[wk0-6]) [Time Frame: Week 0 to Week 6]
Secondary Outcome(s)
Percent Saturation of Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) at Week 22 [Time Frame: Week 22]
Percent Saturation of Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) at Week 6 [Time Frame: Week 6]
Percentage of Participants with Positive Human Antihuman Antibody (HAHA) During the Study [Time Frame: Pre-dose at Weeks 0, 2, 6, 10, 18, 22 and 38]
Percentage of Participants with Positive Neutralizing Human Antihuman Antibody (HAHA) During the Study [Time Frame: Pre-dose at Weeks 0, 2, 6, 10, 18, 22 and 38]
Secondary ID(s)
2013-003030-32
MLN0002SC_201
U1111-1146-5451
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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