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New treatment option for Ulcerative Colitis
Official title A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
ClinicalTrials.gov ID: NCT06100289
What this study is testing
What is Vedolizumab IV?
Vedolizumab IV is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for ulcerative colitis.
Also referred to as ENTYVIO, KYNTELES.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 34 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- The participant weighs ≥10 kg at the time of screening and enrollment into the study.
- 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...
- 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...
- Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids...
You likely can't join if
- Participants who have had previous exposure to approved or investigational anti-integrins, including but not limited to, natalizumab, efalizumab...
- Participants who have had prior exposure to vedolizumab.
- Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.
- Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major...
- The participant has received any live vaccinations within 30 days before first dose of study drug.
- Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study.
See the full eligibility criteria
- The participant weighs ≥10 kg at the time of screening and enrollment into the study.
- 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...
- 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...
- 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]...
- Participants with evidence of UC extending proximal to the rectum (that is, not limited to proctitis), at a minimum.
- 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...
- Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.
- 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...
- Participants who have had prior exposure to vedolizumab.
- Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.
- Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.
- The participant has received any live vaccinations within 30 days before first dose of study drug.
- Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study.
- 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.
- Participants with a current diagnosis of indeterminate colitis.
- Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD).
- Participants with active or latent tuberculosis (TB).
- Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune people (that is, HBsAg negative and hepatitis B surface antibody...
- The participant has any identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
- Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
- Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Loma Linda, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Park Ridge, Illinois, United States
- Detroit, Michigan, United States
- Morristown, New Jersey, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Hershey, Pennsylvania, United States
- North Charleston, South Carolina, United States
- Tacoma, Washington, United States
- Brussels, Belgium
- Liège, Belgium
- Plovdiv, Bulgaria
- Hvidovre, Capital Region, Denmark
- Dublin, Ireland
- Messina, Italy
- Milan, Italy
+ 29 more site(s).
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 study runs about 34 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Loma Linda, California, United States; Orange, California, United States; Palo Alto, California, United States; Park Ridge, Illinois, United States; Detroit, Michigan, United States and 43 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 ClinicalTrials.gov; the study team decides eligibility.