For Healthcare Professionals

Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

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About the study

The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.
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Who can take part

You may be eligible to participate in the study if you meet the following 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

  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 Has withdrawn from Study MLN0002-2003.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 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 study.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +1-877-825-3327Email iconEmail Study Center

Study’s details


Contition

Crohn's Disease,Ulcerative Colitis

Age

2+

Phase

Phase 2

Participants needed

59

Est. Completion Date

Nov 2025

Treatment type

Interventional


Sponsor

Takeda

ClinicalTrials.gov identifier

NCT03196427

Study number

Vedolizumab-2005

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