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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Phoenix Childrens Hospital - Thomas Rd - PIN
  Phoenix, Arizona, United States Recruiting
• Advocate Children's Hospital - Park Ridge - PIN
  Park Ridge, Illinois, United States Recruiting
• Carilion Children's Tanglewood Center
  Roanoke, Virginia, United States Recruiting
• Children's Hospital at Westmead
  Westmead, New South Wales, Australia Recruiting
• Queensland Childrens Hospital
  South Brisbane, Queensland, Australia Recruiting
• Royal Children's Hospital Melbourne - PIN
  Parkville, Victoria, Australia Recruiting

+48 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatment of Ulcerative Colitis and Crohn's Disease with Vedolizumab

  This study is testing if a new medication called Vedolizumab can help adults with Ulcerative Colitis or Crohn's Disease feel better and stay symptom-free over a year.

  Recruiting at 78 sites Phase 4 Takeda · Birmingham, Alabama and 100 other locations · NCT06581328

• Long-term vedolizumab treatment for children and teenagers with ulcerative colitis or Crohn's disease

  This extension tests whether continuing subcutaneous vedolizumab is safe and helps children and teenagers with moderate to severe ulcerative colitis or Crohn's disease stay well.

  Recruiting at 12 sites Phase 3 Takeda · Phoenix, Arizona and 46 other locations · NCT06405087

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

  This study is testing how well the drug vedolizumab works for children and teenagers with ulcerative colitis or Crohn's disease when given through injections after an initial dose through an IV.

  Recruiting at 26 sites Phase 3 Takeda · Phoenix, Arizona and 53 other locations · NCT06100289

• Observing the effects of vedolizumab in adults with ulcerative colitis or Crohn's disease in South Korea

  This study is looking at how well the medication vedolizumab works for adults in South Korea with moderate to severe ulcerative colitis or Crohn's disease who haven't had success with other treatments.

  Recruiting Takeda · Goyang-si, Gyeonggi-do · NCT05428345

• Advanced therapies for moderately to severely active Crohn's disease or ulcerative colitis in adults

  This study tests combinations of risankizumab with either trosunilimab or ABBV-701 in adults with moderately to severely active Crohn's disease or ulcerative colitis.

  Recruiting at 66 sites Phase 2 AbbVie · Dothan, Alabama and 65 other locations · NCT07697456

• Longitudinal Immunophenotyping of People with Inflammatory Bowel Disease

  This study will follow adults with Crohn's disease or ulcerative colitis (and some healthy relatives) over three years to see how their immune cells change over time and how genetics and diet relate to their disease.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07619547

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.