World Health Organization site
Skip Navigation Links

Main
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:  NCT03138655
Date of registration: 19/04/2017
Prospective Registration: Yes
Primary sponsor: Takeda
Public title: Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Scientific title: A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
Date of first enrolment: November 8, 2017
Target sample size: 90
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03138655
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Phase 2
Countries of recruitment
Belgium Canada France Germany Hungary Israel Netherlands Poland
Ukraine United Kingdom United States
Contacts
Name:     Medical Monitor Clinical Science
Address: 
Telephone:
Email:
Affiliation:  Takeda
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Participants weighs >=10 kg at the time of randomization.

2. Has a medical history of moderately to severely active UC during Screening defined as
complete Mayo score of 6 to 12, and a total Mayo subscores of stool frequency and
rectal bleeding >=4 and Mayo endoscopy subscore >=2, or has moderately to severely
active CD defined as simple endoscopic score for Crohn's disease (SES-CD) >=7, and the
CDAI components of average daily abdominal pain score of greater than (>) 1 for the 7
days prior, and total number of liquid/very soft stools >10 within 7 days prior to
first dose of study drug.

3. Has evidence of UC extending proximal to the rectum (that is, not limited to
proctitis) or evidence of CD involving the ileum and/or colon, at a minimum.

4. Has extensive colitis or pancolitis of >8 years duration or left-sided colitis of >12
years duration must have documented evidence that a surveillance colonoscopy was
performed within 12 months prior to their first dose of study drug.

5. Has a family history of colorectal cancer (that is, first-degree relative), personal
history of increased colorectal cancer risk, or other known risk factor must be
up-to-date on colorectal cancer surveillance.

6. The participant's vaccinations are up to date.

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

Corticosteroids:

• Signs and/or symptoms of persistently active disease despite a history of at least
one 4-week induction regimen that included a dose equivalent to or more than
prednisone 1 milligram per kilogram (mg/kg) daily orally for 2 weeks or IV for 1 week.

OR

• Two failed attempts to taper corticosteroids to below a dose equivalent to
prednisone 10 mg daily orally on 2 separate occasions.

OR

• History of significant intolerance to corticosteroids (including, but not limited
to, Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, and
infection).

Immunomodulators:

• Signs and symptoms of persistently active disease despite a history of at least one
8-week regimen of oral azathioprine (AZA) (>=1.5 milligram per kilogram per day
[mg/kg/day]) or 6-mercaptopurine (6-MP) mg/kg (>=1.0 mg/kg/day) or methotrexate (MTX)
(>=10 milligram per square meter [mg/m^2] once a week).

OR

• History of intolerance of at least 1 immunomodulator (including, but not limited to,
nausea/vomiting, abdominal pain, pancreatitis, liver function test (LFT)
abnormalities, lymphopenia, thiopurine methyltransferase genetic mutation, infection).

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

• Signs and symptoms of persistently active disease despite a history of at least 1
induction regimen of infliximab 5 mg/kg IV at Week 0 and Weeks 2 and 6 or adalimumab
2-week regimen of 160 mg on Day 1 and 80 mg on Day 15 if >=40 kg or 80 mg on Day 1 and
40 mg on Day 15 if <40 kg. For any other TNF-a antagonist, the participant must
demonstrate signs and symptoms of persistently active disease despite a history of at
least 1 induction regimen, as determined by the investigator.

OR

• Recurrence of symptoms during maintenance dosing following prior clinical benefit,
that is, fitting clinically with secondary loss of response (discontinuation despite
clinical benefit does not qualify).

OR

• History of intolerance of infliximab or adalimumab (including, but not limited to,
infusion-related reaction, demyelination, congestive heart failure, infection).

8. The participant may be receiving a therapeutic dose of the following drugs:

1. Oral 5-aminosalicylic acid (5-ASA) compounds, providing the dose has been stable
for the 2 weeks prior to first dose of study drug.

2. Oral corticosteroid therapy (prednisolone at a stable dose <=50 mg/day, or
equivalent steroid), provided that the dose has been stable for the 4 weeks prior
to first dose of study drug if corticosteroids have been initiated, or for the 2
weeks prior to first dose of study drug if corticosteroids are being tapered.

3. Probiotics (example, Saccharomyces boulardii), provided the dose has been stable
for the 2 weeks prior to first dose of study drug.

4. Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of
chronic diarrhea.

5. Antibiotics used for the treatment of CD (example, ciprofloxacin, metronidazole),
providing the dose has been stable for the 2 weeks prior to first dose of study
drug.

6. Azathioprine or 6-MP, provided the dose has been stable for the 8 weeks prior to
first dose of study drug.

7. Methotrexate (MTX), provided the dose has been stable for the 8 weeks prior to
first dose of study drug.

Exclusion Criteria:

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

2. Has had prior exposure to vedolizumab.

3. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom
checklist prior to the administration of the first dose of study drug.

4. Requires surgical intervention for UC or CD, or is anticipated to require surgical
intervention for UC or CD during this study.

5. Use of topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories
within 2 weeks of the administration of the first dose of study drug.

6. Has any unstable or uncontrolled cardiovascular, heart failure moderate to severe (New
York Class Association III or IV), pulmonary, hepatic, renal, gastrointestinal (GI),
genitourinary, hematological, coagulation, immunological, endocrine/metabolic,
neurological, or other medical disorder that, in the opinion of the investigator,
would confound the study results or compromise participant safety.

7. Active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed
within 30 days of Screening or during the Screening Period that is positive, defined
as:

- Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR

- A TB skin test reaction >=5 millimeter (mm). Participants with documented
previously treated TB with a negative QuantiFERON test can be included in the
study.




Age minimum: 2 Years
Age maximum: 17 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Ulcerative Colitis
Intervention(s)
Drug: Vedolizumab
Primary Outcome(s)
AUCweek 14: Area Under the Serum Concentration-time Curve from Day 1 to Week 14 [Time Frame: Days 1 post-dose and at multiple timepoints (up to Week 14) post-dose]
Cav, week 14: Average Serum Concentration During a Dosing Interval at Week 14 [Time Frame: Days 1 post-dose and at multiple timepoints (up to Week 14) post-dose]
Ctrough, week 14: Observed Serum Concentration at the end of a Dosing Interval at Week 14 [Time Frame: Week 14 post-dose]
Secondary Outcome(s)
Percentage of CD Participants who Achieve Clinical Response Based on Crohn's Disease Activity Index (CDAI) at Week 14 [Time Frame: Week 14]
Percentage of UC Participants who Achieve Clinical Response Based on Complete Mayo Score at Week 14 [Time Frame: Week 14]
Secondary ID(s)
17/NE/0257
2015-001094-40
MLN0002-2003
MLN0002-2003CTIL
MOH_2017-09-18_000675
U1111-1174-2041
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Takeda Development Center Americas, Inc.
Takeda Development Centre Europe Ltd.
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history