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Taking people in SwitzerlandPhase 3

Vedolizumab Under the Skin for Children With Colitis or Crohn's Disease

Tests how the body handles vedolizumab given under the skin in children with colitis.

Key facts

Who runs it
Takeda
Where
Bern, Lausanne, and Zurich, SwitzerlandSee the 3 sitesAlso in 15 other countries, 54 sites
Trial code
Registry title
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
Status
Recruiting
Phase
Phase 3
People taking part
70 people, planned
Started
22 Jan 2025
Expected to end
16 May 2028
Type of study
Interventional, 5 groups
Treatments tested
  • Vedolizumab IV
  • Vedolizumab SC
Record updated
3 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with moderately to severely active ulcerative colitis or Crohn's disease. They will get vedolizumab under the skin for up to 34 weeks.

Age
2 Years to 17 Years
Sex
All sexes can join.
Disease stage
Ulcerative colitis or Crohn's disease diagnosed at least 1 month before screening, with moderately to severely active disease. Ulcerative colitis must reach beyond the rectum.
Earlier treatment
Must have failed, lost response to, or not tolerated at least 1 of: corticosteroids, immunomodulators, or TNF-α antagonist therapy. Must not have had vedolizumab or anti-integrin drugs before.
Biomarker or test result
Ulcerative colitis: modified Mayo score of 5 to 9 with Mayo endoscopic subscore of ≥2. Crohn's disease: PCDAI >30 and SES-CD >6 (or ≥4 if disease is confined to terminal ileum).

Main reasons for not taking part

  • Previous vedolizumab or anti-integrin treatment
  • Active or latent tuberculosis
  • Hepatitis B infection (positive HBsAg or HBcAb)
  • Immune system deficiency, such as HIV infection or organ transplantation
  • Surgery needed now or expected, or earlier colectomy, ileostomy or colostomy

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • The participant weighs ≥10 kg at the time of screening and enrollment into the study
  • 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
  • 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)
  • Participants with evidence of UC extending proximal to the rectum (that is, not limited to proctitis), at a minimum
  • 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
  • Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines

Who cannot take part

  • 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
  • Participants who have had prior exposure to vedolizumab
  • The participant has received any live vaccinations within 30 days before first dose of study drug
  • Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study
  • Participants with hypersensitivity or allergies to vedolizumab or any of its excipients
  • Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders
  • 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
  • Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD)
  • Participants with active or latent tuberculosis (TB)
  • 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
  • The participant has any identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation)
  • Participants with a current diagnosis of indeterminate colitis
  • Participants with positive stool studies for ova and/or parasites or stool culture at screening visit
  • Participants with positive Clostridioides difficile (C difficile) stool test at screening visit

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 17 years old?

Where in Switzerland

Also in 15 other countries, 54 sites

  • Inselspital, Universitatsspital Bern, Kinderklinik, Julie-von-Jenner-HausBern, SwitzerlandContact: Christiane Sokollik (principal investigator)Taking people
  • Centre Hospitalier Universitaire Vaudois (CHUV)Lausanne, SwitzerlandContact: Andreas Nydegger (principal investigator)Taking people
  • Universitats-KinderspitalZurich, SwitzerlandContact: Carsten Posovszky (principal investigator)Taking people

About the trial

What the trial wants to find out

The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC).

Read full original descriptionShow less

The participants will be treated with vedolizumab for up to 34 weeks.

During the study, participants will visit their study clinic several times.

The 5 groups in the trial

  • Induction Period: Participants ≥30 kg, Vedolizumab (High Dose) IVTreatment being tested

    Participants weighing ≥30 kg will receive vedolizumab (High Dose) IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.

    Treatment: Vedolizumab IV

  • Induction Period: Participants >15 to <30 kg, Vedolizumab (Medium Dose) IVTreatment being tested

    Participants weighing \>15 to \<30 kg will receive vedolizumab (Medium Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.

    Treatment: Vedolizumab IV

  • Induction Period: Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose) IVTreatment being tested

    Participants weighing ≥10 to ≤15 kg will receive vedolizumab (Low Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.

    Treatment: Vedolizumab IV

  • Maintenance Period: Participants ≥30 kg, Vedolizumab 108 mg SC Q2WTreatment being tested

    Participants with clinical response at Week 14 weighing ≥30 kg will receive vedolizumab 108 mg, SC injection, Q2W from Week 14 to Week 32 in the Maintenance Period.

    Treatment: Vedolizumab SC

  • Maintenance Period: Participants ≥10 to <30 kg, Vedolizumab 108 mg SC Q4WTreatment being tested

    Participants with clinical response at Week 14 weighing ≥10 to \<30 kg will receive vedolizumab 108 mg, SC injection, Q4W from Week 14 to Week 30 in the Maintenance Period.

    Treatment: Vedolizumab SC

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Vedolizumab Under the Skin for Children With Colitis or Crohn's DiseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06100289, who can take part
Record updated
3 August 2026