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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: 18 January 2021
Main ID:  NCT03196427
Date of registration: 20/06/2017
Prospective Registration: Yes
Primary sponsor: Takeda
Public title: Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Scientific title: A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
Date of first enrolment: July 30, 2018
Target sample size: 80
Recruitment status: Active, not recruiting
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 2
Countries of recruitment
Belgium Canada France Hungary Israel Netherlands Poland Ukraine
United Kingdom United States
Name:     Medical Director
Affiliation:  Takeda
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Is male or female with Ulcerative Colitis or Crohn's Disease and was between 2 to 17
years, inclusive, at the time of randomization for Study MLN0002-2003.

(Note: A participant remains eligible to participate in this study after they reach 18
years of age if they continue to meet the inclusion criteria and do not meet any
exclusion criteria.)

2. Has completed Study MLN0002-2003 and, at Week 22, achieved clinical response as
defined by a reduction of partial Mayo score of >= 2 points and >= 25% from Baseline,
or a reduction of the paediatric ulcerative colitis activity index (PUCAI) of >= 20
points from baseline for participants with UC; or a reduction of the CDAI as defined
by a >= 70-point decrease from Baseline or a decrease of pediatric crohn's disease
activity index (PCDAI) of >= 15 points for participants with CD.

3. May be receiving a therapeutic dose of the following drugs:

- Oral 5-aminosalicylic acid (5-ASA) compounds.

- Oral corticosteroid therapy (prednisone or equivalent steroid at a dose less than
or equal to [<=] 50 milligram per day [mg/day], budesonide at a dose <= 9

- Topical (rectal) treatment with 5-ASAs or corticosteroids.

- Probiotics (example, Saccharomyces boulardii).

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

- Antibiotics used for the treatment of CD (i.e., ciprofloxacin, metronidazole).

- Azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX), provided the
participant was receiving this medication during prior participation in

4. The participant's vaccinations are up to date as per inclusion criteria number 10 in

Exclusion Criteria:

1. Is female and is lactating or pregnant.

2. Has hypersensitivity or allergies to vedolizumab or any of its excipients.

3. Has withdrawn from Study MLN0002-2003.

4. Has developed any new 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.

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

6. Currently requires major surgical intervention for ulcerative colitis (UC) or CD
(example, bowel resection), or is anticipated to require major surgical intervention
for UC or CD during the study.

7. Has other serious comorbidities that will limit his or her ability to complete the

Age minimum: 2 Years
Age maximum: 17 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Ulcerative Colitis
Drug: Vedolizumab
Primary Outcome(s)
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Baseline up to 5 years]
Secondary Outcome(s)
Change from Baseline in Body Mass Index (BMI) at Week 24 and Every 24 Weeks, Thereafter up to 5 years [Time Frame: Baseline up to 5 years]
Change from Baseline in Height at Week 24 and Every 24 Weeks, Thereafter up to 5 years [Time Frame: Baseline up to 5 years]
Change from Baseline in IMPACT-III Total and Subscale Scores at Week 24 and Every 24 weeks, Thereafter up to 5 years [Time Frame: Baseline up to 5 years]
Change from Baseline in Weight at Week 24 and Every 24 Weeks, Thereafter up to 5 years [Time Frame: Baseline up to 5 years]
Height Velocity at Week 48 and Every 48 weeks, Thereafter up to 5 years [Time Frame: Baseline up to 5 years]
Percentage of Participants Achieving Tanner Stage V Scale [Time Frame: Baseline up to 5 years]
Percentage of Participants With CD Meeting 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES-CD) Score at Week 32 [Time Frame: Week 32]
Percentage of Participants With UC Meeting Complete Mayo Score Response at Week 32 [Time Frame: Week 32]
Time to Major Inflammatory Bowel Disease (IBD) - Related Events [Time Frame: Baseline up to 5 years]
Secondary ID(s)
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 available:
Date Posted:
Date Completed:
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