A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC) (NCT04779307) | Clinical Trial Compass
CompletedPhase 3
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)
United States121 participantsStarted 2021-10-19
Plain-language summary
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab.
The main aim of the study is to check if participants achieve remission after treatment with vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no or limited signs of disease.
The study is also evaluating side effects of vedolizumab in the children and teenager with moderately to severely active ulcerative colitis.
Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive 1 of 3 doses of vedolizumab once every 8 weeks. They will receive the same dose every time.
Who can participate
Age range2 Years – 17 Years
SexALL
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Inclusion criteria
✓. Has moderately to severely active UC, unresponsive or intolerant to their current standard of care (SOC).
✓. Weighs ≥10 kg at the time of screening and enrollment into the study.
✓. Participants with UC diagnosed at least 1 month before screening. Participants with moderately to severely active UC based on 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) at screening endoscopy.
✓. Has failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids (eg, azathioprine \[AZA\], 6-mercaptopurine \[6-MP\], methotrexate \[MTX\]), immunomodulators, and/or tumor necrosis factor alpha (TNF-α) antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids.
✓. Has evidence of UC extending proximal to the rectum (i.e., not limited to proctitis), at a minimum.
✓. Has 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.
What they're measuring
1
Percentage of Participants With Clinical Remission at Week 54 Based on Modified Mayo Score
. Participants with vaccinations that are up-to-date based on the countrywide, accepted schedule of childhood vaccines.
Exclusion criteria
✕. Has 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 or rituximab.
✕. Has received an investigational biologic within 60 days or 5 half-lives before screening (whichever is longer); or an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
✕. Has active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
✕. Has had clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 \[COVID-19\]) within 30 days prior to first dose of study drug.
✕. Has received any live vaccinations within 30 days prior to first dose of study drug.
✕. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC during this study.
✕. Has had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, or known fixed stenosis of the intestine.
✕. Participants with a current diagnosis of indeterminate colitis.