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A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)
EU CTIS ID: 2023-509018-12-00
What this study is testing
The primary objective of this study is to evaluate the efficacy of 2 different dose regimens of vedolizumab IV in pediatric subjects with moderately to severely active UC during maintenance therapy, based on clinical remission at Week 54.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The subject is aged 2 to 17 years, inclusive, at the time of screening and enrollment into the maintenance phase of the study.
- The subject weighs ≥10 kg at the time of screening and enrollment into the study.
- Subjects with UC diagnosed at least 1 month before screening. Subjects 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.
- Subjects who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, AZA, 6-MP, MTX), and/or TNF-α antagonist therapy (eg, infliximab, adalimumab). This includes subjects 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.
- Subjects with evidence of UC extending proximal to the rectum (ie, not limited to proctitis), at a minimum.
- Subjects 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.
You likely can't join if
- 1. Subjects who have had previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or AMG 181, or MAdCAM-1 antagonists or rituximab.
- 10. The subject has other serious comorbidities that will limit his or her ability to complete the study.
- 2. Subjects who have had prior exposure to vedolizumab.
- 3. Subjects with hypersensitivity or allergies to vedolizumab or any of its excipients.
- 4. Subjects who have received either (1) an investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before screening (whichever is longer); or (2) an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
- 5. Subjects with active cerebral/meningeal disease, signs/symptoms or history of PML or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
See the full eligibility criteria
Who can join
- The subject is aged 2 to 17 years, inclusive, at the time of screening and enrollment into the maintenance phase of the study.
- The subject weighs ≥10 kg at the time of screening and enrollment into the study.
- Subjects with UC diagnosed at least 1 month before screening. Subjects 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.
- Subjects who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, AZA, 6-MP, MTX), and/or TNF-α antagonist therapy (eg, infliximab, adalimumab). This includes subjects 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.
- Subjects with evidence of UC extending proximal to the rectum (ie, not limited to proctitis), at a minimum.
- Subjects 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.
- Subjects with vaccinations that are up-to-date based on the countrywide, accepted schedule of childhood vaccines.
What rules you out
- 1. Subjects who have had previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or AMG 181, or MAdCAM-1 antagonists or rituximab.
- 10. The subject has other serious comorbidities that will limit his or her ability to complete the study.
- 2. Subjects who have had prior exposure to vedolizumab.
- 3. Subjects with hypersensitivity or allergies to vedolizumab or any of its excipients.
- 4. Subjects who have received either (1) an investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before screening (whichever is longer); or (2) an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
- 5. Subjects with active cerebral/meningeal disease, signs/symptoms or history of PML or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
- 8. Subjects who currently require surgical intervention or are anticipated to require surgical intervention for UC during this study.
- 9. Subjects who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, or known fixed stenosis of the intestine.
- 11. Subjects with a current diagnosis of indeterminate colitis.
- 12. Subjects with clinical features suggesting monogenic very early onset inflammatory bowel disease.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Australia
- United States
- Korea, Republic of
- United Kingdom
- Israel
- Japan
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Australia; United States; Korea, Republic of; United Kingdom; Israel and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.