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Vedolizumab for Children and Teenagers with Ulcerative Colitis or Crohn's Disease

This study is looking at how a medicine called vedolizumab works in the bodies of children and teenagers (ages 2 to 17) who have moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD). Participants will first receive vedolizumab through an IV (into a vein) for several weeks. If their condition improves, they will then switch to vedolizumab given as an injection under the skin (subcutaneous, SC) for up to 20 weeks. The main goal is to understand how the body processes the SC form of vedolizumab. The study is currently enrolling about 70 patients.

Study design
This is an interventional study involving approximately 70 participants. It is a multi-center trial conducted globally.
What's involved
Participants will receive vedolizumab treatment for up to 34 weeks. They will visit the study clinic several times during this period.
Compensation
Not stated in the trial record.
Follow-up
The main measurements for the study are taken at Week 34.

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NCT06100289

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Recruiting
PHASE3Ages 2–17InterventionalTreatment
Takeda
~70 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Vedolizumab IVVedolizumab SC

At a glance

Recruiting sites
26 of 54 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ctrough,ss: Steady-state Median Observed Plasma Concentration at the End of a Dosing Interval for Vedolizumab at Week 34
Measured over Predose at Week 34
+1 more outcome measured

Conditions

Ulcerative Colitis
Crohn's Disease

Explore related trials

Crohn DiseaseUlcerative Colitis

Where it's being run

54 sites across 31 states
Italy4
South Korea4
Spain4
California3
Poland3
Portugal3
Serbia3
Ohio2

Study leadership

  • Study Director · STUDY_DIRECTOR · Takeda

Who to contact

Takeda Contact
[email protected]
+1-877-825-3327
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Eligibility criteria

Inclusion

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.

What this trial measures

  • Ctrough,ss: Steady-state Median Observed Plasma Concentration at the End of a Dosing Interval for Vedolizumab at Week 34Predose at Week 34
  • Cavg,ss: Average Serum Concentration at Steady-state for Vedolizumab at Week 34Multiple time points prior to Week 34; pre-dose at Week 34