Vedolizumab treatment for children and teenagers 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 study aims to evaluate how children and teenagers with moderately to severely active ulcerative colitis or Crohn's disease process the drug vedolizumab when administered subcutaneously. Participants will receive initial intravenous doses of vedolizumab followed by subcutaneous injections based on their weight. The study will assess the pharmacokinetics, safety, and immunogenicity of vedolizumab over a treatment period of up to 34 weeks. Approximately 70 patients will be enrolled and monitored through multiple clinic visits during the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. The participant weighs ≥10 kg at the time of screening and enrollment into the study.
2. Participants with UC or CD diagnosed at least 1 month before screening. Participants with moderately to severely active disease defined as:

   * Participants with UC: a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (with the presence of mucosal friability excluding an endoscopic subscore of 1 and mandating a score of at least 2). (The results of screening endoscopy should be applied.)
   * Participants with CD: a pediatric Crohn's disease activity index (PCDAI) \>30 and a simple endoscopic score for Crohn's disease (SES-CD) \>6 (or an SES-CD ≥4 if disease is confined to terminal ileum) at screening endoscopy.
3. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (for example, azathioprine \[AZA\], 6-mercaptopurine \[6-MP\], methotrexate \[MTX\]), and/or tumor necrosis factor (TNF)-α antagonist therapy (for example, infliximab, adalimumab).
4. Participants with evidence of UC extending proximal to the rectum (that is, not limited to proctitis), at a minimum.
5. Participants with extensive colitis or pancolitis of \>8 years' duration or left-sided colitis of \>12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.
6. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.

Exclusion Criteria:

1. Participants who have had previous exposure to approved or investigational anti-integrins, including but not limited to, natalizumab, efalizumab, etrolizumab, or abrilumab (AMG 181); or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists (ontamalimab), or rituximab.
2. Participants who have had prior exposure to vedolizumab.
3. Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.
4. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.
5. The participant has received any live vaccinations within 30 days before first dose of study drug.
6. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study.
7. Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or \>3 small intestine resections.
8. Participants with a current diagnosis of indeterminate colitis.
9. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD).
10. Participants with active or latent tuberculosis (TB).
11. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune subjects (that is, HBsAg negative and hepatitis B surface antibody \[anti-HBs\]-positive) may, however, be included.
12. The participant has any identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation).
13. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
14. Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.

Where it's running

• Children's Hospital Of Orange County
  Orange, California, United States Recruiting
• Children's Hospital of Michigan
  Detroit, Michigan, United States Recruiting
• The University of Oklahoma Health Sciences Center
  Oklahoma City, Oklahoma, United States Recruiting
• Cliniques Universitaires Saint-Luc
  Brussels, Belgium Recruiting
• Centre Hospitalier Chretien MontLegia
  Liège, Belgium Recruiting
• University Hospital "Saint George"
  Plovdiv, Bulgaria Recruiting

+4 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 with ulcerative colitis or Crohn's disease

  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.

  Recruiting at 44 sites Phase 3 Takeda · Mobile, Alabama and 97 other locations · NCT05442567

• 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.