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

An Open-Label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy

Phase 3 Interventional Takeda · NCT06100289

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.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment70 (estimated)
Ages2 Years to 17 Years
SexAll
SponsorTakeda Industry-sponsored
Drugs / interventionsinfliximab, adalimumab, natalizumab, efalizumab, etrolizumab, abrilumab, ontamalimab, rituximab, vedolizumab, methotrexate
Locations57 sites (Garden Grove, California and 56 other locations)
Trial IDNCT06100289 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children and teenagers weighing at least 10 kg with a diagnosis of moderately to severely active ulcerative colitis or Crohn's disease.

Not a fit: Patients who have not previously failed or been intolerant to corticosteroids or immunomodulators may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for pediatric patients suffering from ulcerative colitis or Crohn's disease.

How similar studies have performed: Other studies have shown success with vedolizumab in adult populations, but this specific approach in pediatric patients is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Garden Grove, California and 56 other locations

+7 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 2026-06-10 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.