A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
Recruiting · NCT06100289 · Interventional (participants receive a specific treatment) · Lead sponsor: Takeda
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
2 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion 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 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.
- 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).
- 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 screening.
- Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.
Exclusion criteria
- 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.
- 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 subjects (that is, HBsAg negative and hepatitis B surface antibody \[anti-HBs\]-positive) may, however, be included.
- 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.
Where it is running
60 locations listed across 11 US states.
- Phoenix Children's Hospital - Phoenix, Arizona, United States
- Phoenix Children's Hospital - Phoenix, Arizona, United States
- Loma Linda University School of Medicine - Loma Linda, California, United States
- Loma Linda University School of Medicine - Loma Linda, California, United States
- Children's Hospital Of Orange County - Orange, California, United States
- Children's Hospital Of Orange County - Orange, California, United States
- Stanford Children's Health - Palo Alto, California, United States
- Stanford Children's Health - Palo Alto, California, United States
- Advocate Children's Hospital - Park Ridge, Illinois, United States
- Advocate Children's Hospital - Park Ridge, Illinois, United States
- Children's Hospital of Michigan - Detroit, Michigan, United States
- Children's Hospital of Michigan - Detroit, Michigan, United States
- Atlantic Health System - Morristown, New Jersey, United States
- Atlantic Health System - Morristown, New Jersey, United States
- New York Presbyterian Hospital, Weill Cornell Medical College - New York, New York, United States
- New York Presbyterian Hospital, Weill Cornell Medical College - New York, New York, United States
- University Hospitals Cleveland Medical Center - Cleveland, Ohio, United States
- Cleveland Clinic Foundation - Cleveland, Ohio, United States
- University Hospitals Cleveland Medical Center - Cleveland, Ohio, United States
- Cleveland Clinic Foundation - Cleveland, Ohio, United States
- The University of Oklahoma Health Sciences Center - Oklahoma City, Oklahoma, United States
- The University of Oklahoma Health Sciences Center - Oklahoma City, Oklahoma, United States
- Penn State Health Milton S. Hershey Medical Center/ Penn State University College of Medicine - Hershey, Pennsylvania, United States
- Penn State Health Milton S. Hershey Medical Center/ Penn State University College of Medicine - Hershey, Pennsylvania, United States
- Medical University of South Carolina - North Charleston, South Carolina, United States
- Medical University of South Carolina - North Charleston, South Carolina, United States
- MultiCare Institute for Research & Innovation - Tacoma, Washington, United States
- MultiCare Institute for Research & Innovation - Tacoma, Washington, United States
- University Children's Hospital - Belgrade, Serbia
- Mother and child helath care Institute of Serbia dr Vukan Cupic - Belgrade, Serbia
- University Children's Hospital - Belgrade, Serbia
- Mother and child helath care Institute of Serbia dr Vukan Cupic - Belgrade, Serbia
- Inselspital, Universitatsspital Bern, Kinderklinik, Julie-von-Jenner-Haus - Bern, Switzerland
- Inselspital, Universitatsspital Bern, Kinderklinik, Julie-von-Jenner-Haus - Bern, Switzerland
- Cliniques Universitaires Saint-Luc - Brussels, Belgium
- Cliniques Universitaires Saint-Luc - Brussels, Belgium
- Dr Victor Gomoiu Clinical Children Hospital - Bucharest, Romania
- Spitalul Clinic de Urgenta Pentru Copii ,,Grigore Alexandrescu, - Bucharest, Romania
- Dr Victor Gomoiu Clinical Children Hospital - Bucharest, Romania
- Spitalul Clinic de Urgenta Pentru Copii ,,Grigore Alexandrescu, - Bucharest, Romania
- Changhua Christian Hospital - Changhua, Taiwan
- Changhua Christian Hospital - Changhua, Taiwan
- Hospital Pediatrico - Unidade Local de Saude de Coimbra - Coimbra, Portugal
- Hospital Pediatrico - Unidade Local de Saude de Coimbra - Coimbra, Portugal
- Kyungpook National University Chilgok Hospital (KNUCH) - Daegu, South Korea
- Kyungpook National University Chilgok Hospital (KNUCH) - Daegu, South Korea
- Childrens Health Ireland - Dublin, Ireland
- Childrens Health Ireland - Dublin, Ireland
- Complejo Hospitalario Universitario de Ferrol - Ferrol, Spain
- Complejo Hospitalario Universitario de Ferrol - Ferrol, Spain
- Kaohsiung Medical University Chung-Ho Memorial Hospital - Kaohsiung City, Taiwan
- Kaohsiung Medical University Chung-Ho Memorial Hospital - Kaohsiung City, Taiwan
- Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE - Lisbon, Portugal
- Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE - Lisbon, Portugal
- Centre Hospitalier Chretien MontLegia - Liège, Belgium
- Centre Hospitalier Chretien MontLegia - Liège, Belgium
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Azienda Ospedaliera Universitaria Gaetano Martino Messina - Messina, Italy
- Azienda Ospedaliera Universitaria Gaetano Martino Messina - Messina, Italy
Showing 60 of 108 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →