A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease (NCT06100289) | Clinical Trial Compass
RecruitingPhase 3
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
United States70 participantsStarted 2025-01-22
Plain-language summary
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).
The participants will be treated with vedolizumab for up to 34 weeks.
During the study, participants will visit their study clinic several times.
Who can participate
Age range2 Years ā 17 Years
SexALL
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Inclusion criteria
ā. The participant weighs ā„10 kg at the time of screening and enrollment into the study.
ā. Participants with UC or CD diagnosed at least 1 month before screening. Participants with moderately to severely active disease defined as:
ā. 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)-Ī± antagonist therapy (for example, infliximab, adalimumab).
ā. Participants with evidence of UC extending proximal to the rectum (that is, not limited to proctitis), at a minimum.
ā. 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.
ā. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.
Exclusion criteria
ā. 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.
ā. Participants who have had prior exposure to vedolizumab.
ā. Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.
What they're measuring
1
Ctrough,ss: Steady-state Median Observed Plasma Concentration at the End of a Dosing Interval for Vedolizumab at Week 34
Timeframe: Predose at Week 34
2
Cavg,ss: Average Serum Concentration at Steady-state for Vedolizumab at Week 34
Timeframe: Multiple time points prior to Week 34; pre-dose at Week 34
ā. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.
ā. The participant has received any live vaccinations within 30 days before first dose of study drug.
ā. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study.
ā. 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.
ā. Participants with a current diagnosis of indeterminate colitis.