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RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
2 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 34 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The participants will be treated with vedolizumab for up to 34 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how the body handles vedolizumab given as a shot just under the skin. It is for children and teens with moderate to severe ulcerative colitis or Crohn’s disease, which cause swelling in the bowel. Treatment lasts up to 34 weeks, with several study clinic visits.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Weigh at least 10 kg (about 22 pounds) at screening and when joining.
  • Have ulcerative colitis or Crohn’s disease diagnosed at least 1 month before screening. Symptoms and a bowel scope exam must meet the study’s rules for moderate to severe disease.
  • Have tried at least one steroid, immune-system medicine, or TNF blocker that did not work, stopped working, or caused side effects you could not tolerate.
  • If you have ulcerative colitis, it must affect more than just the rectum, the last part of the bowel.
  • If colitis has affected most or all of the colon for over 8 years, or the left side for over 12 years, have a clear follow-up colonoscopy result from the past 12 months. A colonoscopy is a camera exam of the colon.
  • Be up to date on childhood vaccines based on your country’s schedule.

Who can't join

  • Have used vedolizumab, rituximab, or certain other immune medicines called anti-integrins or MAdCAM-1 blockers, or are allergic to vedolizumab or its ingredients.
  • Have active disease of the brain or its coverings, another major nerve-system disorder, or signs or a history of PML, a serious brain disease.
  • Have received a live vaccine within 30 days before the first study dose.
  • Need surgery for ulcerative colitis or Crohn’s disease now, or are expected to need it during the study.
  • Have had most or all of the colon removed, an opening that lets bowel waste leave through the belly, an internal stool pouch, a fixed bowel narrowing, short bowel syndrome, or more than 3 surgeries removing parts of the small bowel.
  • Have colitis whose type is unclear, or signs of bowel disease that starts very early in life and is caused by a single gene.
  • Have active or inactive tuberculosis, certain positive hepatitis B tests, or a condition that weakens the immune system, such as HIV or an organ transplant. Immunity to hepatitis B alone does not rule you out.
  • Have screening stool tests that show parasites, parasite eggs, bacteria on a stool culture, or C. difficile, a germ that can cause diarrhea.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. The participant weighs ≥10 kg at the time of screening and enrollment into the study. 2. 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. 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. Exclusion Criteria: 1. 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. 2. Participants who have had prior exposure to vedolizumab. 3. Participants with hypersensitivity or allergies to vedolizumab or any of its excipients. 4. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders. 5. The participant has received any live vaccinations within 30 days before first dose of study drug. 6. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study. 7. 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. 8. Participants with a current diagnosis of indeterminate colitis. 9. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD). 10. Participants with active or latent tuberculosis (TB). 11. 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. 12. The participant has any identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation). 13. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit. 14. Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.

Study sites (14)

AZ

CA

IL

MI

NJ

NY

OH

OK

PA

  • Penn State Health Milton S. Hershey Medical Center/ Penn State University College of Medicine · Hershey, PA 17033More trials in Hershey

SC

WA