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Vedolizumab treatment for children with ulcerative colitis or Crohn's disease

A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Intravenous in Pediatric Patients With Ulcerative Colitis or Crohn's Disease

Phase 3 Interventional Takeda · NCT05442567

This study is testing how safe the medication vedolizumab is for children with ulcerative colitis or Crohn's disease who have already tried it before.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment240 (estimated)
Ages2 Years and up
SexAll
SponsorTakeda Industry-sponsored
Drugs / interventionsvedolizumab
Locations98 sites (Mobile, Alabama and 97 other locations)
Trial IDNCT05442567 on ClinicalTrials.gov

What this trial studies

This multi-center clinical trial aims to evaluate the long-term safety of vedolizumab in pediatric patients who have previously participated in parent studies for ulcerative colitis (UC) or Crohn's disease (CD). Up to 240 participants will be enrolled, with those in the Treatment Cohort receiving vedolizumab intravenously at specified dosages based on their weight. The study will monitor participants for safety and efficacy over an extended period, following their initial treatment in the parent studies.

Who should consider this trial

Good fit: Ideal candidates are children aged 10 kg or more who have completed prior studies and achieved a corticosteroid-free clinical response.

Not a fit: Patients who have not participated in the previous studies or those who do not meet the eligibility criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of vedolizumab for treating children with UC or CD.

How similar studies have performed: Other studies have shown promising results with vedolizumab in adult populations, but this specific pediatric application is being explored for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Main Inclusion Criteria:

For Treatment Cohort:

1. The participant should have completed Study MLN0002-3024 or Study MLN0002-3025 and achieved corticosteroid-free clinical response at Week 54 (and has tapered off of steroids, as applicable, at least 12 weeks before Week 54) as defined by a reduction of partial Mayo score of ≥2 points and ≥25% from baseline for participants with UC, or by a decrease of pediatric Crohn's disease activity index (PCDAI) of ≥15 points for participants with CD and with total PCDAI ≤30.
2. A male participant who is sexually active with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with or without spermicide) from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and for 18 weeks after last dose. The female partner of a male participant should also be advised to use a highly effective method of contraception.
3. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of participant/parental informed consent and/or pediatric assent throughout the duration of the study and 18 weeks after the last dose.

For Observational Cohort:

1\. The participant has received at least 1 dose of vedolizumab during Study MLN0002-3024 or Study MLN0002-3025 and early terminated OR completed the Week 54 visit of Study MLN0002-3024 or Study MLN0002-3025 but was not eligible to enroll in the treatment cohort of this study.

Main Exclusion Criteria:

For Treatment Cohort only:

1. The participant currently requires major surgical intervention for UC or CD (e.g., bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.
2. The participant 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.
3. The participant has other serious comorbidities that will limit their ability to complete the study.
4. The participant is unable to comply with all study assessments.
5. The participant has hypersensitivity or allergies to any of the vedolizumab excipients.
6. The participant is lactating or pregnant.

Where this trial is running

Mobile, Alabama and 97 other locations

+48 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative ColitisCrohn's DiseaseDrug Therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.