Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
About the study
Who can take part
INCLUSION CRITERIA
Inclusion Criteria:
1. Is male or female with UC or CD 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.)
- 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]) provided the participant was receiving this medication during prior participation in MLN0002-2003.
- Topical (rectal) treatment with 5-ASA 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 MLN0002-2003.
4. The participant's vaccinations are up to date as per inclusion criteria number 10 in MLN0002-2003.
EXCLUSION CRITERIA
Exclusion Criteria:
- Is female and is lactating or pregnant.
- Has hypersensitivity or allergies to vedolizumab or any of its excipients.
- Has withdrawn from Study MLN0002-2003.
- 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.
- Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug.
- Currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
- Has other serious comorbidities that will limit his or her ability to complete the study.
Study Locations
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How to Apply
Study’s details
Contition
Ulcerative Colitis,Crohn's Disease
Age (in years)
2 - 17
Phase
PHASE2
Participants needed
59
Est. Completion Date
Nov 24, 2025
Treatment type
INTERVENTIONAL
Sponsor
Takeda
ClinicalTrials.gov identifier
NCT03196427
Study number
Vedolizumab-2005
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