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

Inclusion Criteria:


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.)


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.


May be receiving a therapeutic dose of the following drugs:


  1. Oral 5-aminosalicylic acid (5-ASA) compounds.
  2. 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.
  3. Topical (rectal) treatment with 5-ASA or corticosteroids.
  4. Probiotics (example, Saccharomyces boulardii).
  5. Antidiarrheals (example, loperamide, diphenoxylate with atropine) for control of chronic diarrhea.
  6. Antibiotics used for the treatment of CD (i.e., ciprofloxacin, metronidazole).
  7. Azathioprine (AZA) or 6-mercaptopurine (6-MP) or methotrexate (MTX), provided the participant was receiving this medication during prior participation in MLN0002-2003.
  8. The participant's vaccinations are up to date as per inclusion criteria number 10 in MLN0002-2003.


EXCLUSION CRITERIA

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 Has withdrawn from Study MLN0002-2003.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.

Study’s details


Contition

Ulcerative Colitis,Crohn's Disease

Age (in years)

2 - 17

Phase

Phase 2

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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