Ulcerative Colitis study: Vedolizumab IV vs Vedolizumab SC
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?
an investigational intravenous medicine being studied as a potential treatment for ulcerative colitis in children and teens is designed to block the α4β7 integrin, which may reduce inflammation in the gut
Also referred to as ENTYVIO, KYNTELES, MLN0002.
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 study aims to find out how a child's or teenager's body processes vedolizumab when given under the skin.
- Who it's for
- Children and teenagers who have moderately to severely active ulcerative colitis or Crohn's disease.
- What's involved
- Participants will receive subcutaneous (under‑the‑skin) injections of vedolizumab for up to 34 weeks and will attend several clinic visits for monitoring.
- Time commitment
- The trial lasts up to 34 weeks and includes multiple visits to the study clinic.
- 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: 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...
- Participants with evidence of UC extending proximal to the rectum (that is, not limited to proctitis), at a minimum.
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: 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)
- 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).
- 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 is enrolling
- Orange, California, United States
- Detroit, Michigan, United States
- Oklahoma City, Oklahoma, United States
- Brussels, Belgium
- Liège, Belgium
- Plovdiv, Bulgaria
- Messina, Italy
- Milan, Italy
- Bunkyo-ku, Tokyo, Japan
- Warsaw, Masovian Voivodeship, Poland
- Rzeszów, Poland
- Warsaw, Poland
- Lisbon, Portugal
- Bucharest, Romania
- Belgrade, Serbia
- Daegu, South Korea
- Seoul, South Korea
- Seville, Spain
- Lausanne, Canton of Vaud, Switzerland
- Bern, Switzerland
+ 3 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, but 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?
This study is enrolling now at Orange, California, United States; Detroit, Michigan, United States; Oklahoma City, Oklahoma, United States; Brussels, Belgium; Liège, Belgium; Plovdiv, Bulgaria and 17 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.