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Clinical Trials in the USA / NCT06100289
Recruiting Phase 3

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

NCT06100289 · tracked via the Priya Life Science USA tracker
Sponsor
Takeda
Phase
Phase 3
Started
2025-01-22
Last updated
2026-08-03

Condition(s) studied

Ulcerative ColitisCrohn's Disease

Investigational drug(s) / intervention(s)

Vedolizumab IVVedolizumab SC

Vedolizumab IV: Vedolizumab IV injection.

Vedolizumab SC: Vedolizumab SC injection.

Study summary

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (54)

FacilityCityRegionStatus
Phoenix Children's Hospital Phoenix Arizona Not Yet Recruiting
Loma Linda University School of Medicine Loma Linda California Active Not Recruiting
Children's Hospital Of Orange County Orange California Recruiting
Stanford Children's Health Palo Alto California Active Not Recruiting
Advocate Children's Hospital Park Ridge Illinois Active Not Recruiting
Children's Hospital of Michigan Detroit Michigan Recruiting
Atlantic Health System Morristown New Jersey Active Not Recruiting
New York Presbyterian Hospital, Weill Cornell Medical College New York New York Active Not Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Active Not Recruiting
Cleveland Clinic Foundation Cleveland Ohio Active Not Recruiting
The University of Oklahoma Health Sciences Center Oklahoma City Oklahoma Recruiting
Penn State Health Milton S. Hershey Medical Center/ Penn State University College of Medicine Hershey Pennsylvania Active Not Recruiting
Medical University of South Carolina North Charleston South Carolina Not Yet Recruiting
MultiCare Institute for Research & Innovation Tacoma Washington Not Yet Recruiting
Cliniques Universitaires Saint-Luc Brussels Belgium Recruiting
Centre Hospitalier Chretien MontLegia Liège Belgium Recruiting
University Hospital "Saint George" Plovdiv Bulgaria Recruiting
Hvidovre University Hospital Hvidovre Capital Region Active Not Recruiting
Childrens Health Ireland Dublin Ireland Active Not Recruiting
Azienda Ospedaliera Universitaria Gaetano Martino Messina Messina Italy Recruiting
V. Buzzi Hospital Milan Italy Recruiting
Unita Operativa Complessa Di Pediatria Medica Pescara Italy Active Not Recruiting
IRCCS Ospedale Pediatrico Bambino Gesu Rome Italy Active Not Recruiting
Kurume University Hospital Kurume Fukuoka Active Not Recruiting
Juntendo University Hospital Bunkyo-ku Tokyo Recruiting
National Center for Child Health and Development (NCCHD) Setagaya-Ku Tokyo Active Not Recruiting
Radboud University Medical Center Nijmegen Netherlands Active Not Recruiting
Instytut Pomnik - Centrum Zdrowia Dziecka Warsaw Masovian Voivodeship Recruiting
Korczowski Bartosz, Gabinet Lekarski Rzeszów Poland Recruiting
Medical Network Sp. Z.o.o. WIP Warsaw IBD Point Profesor Kierkus Warsaw Poland Recruiting
SPSK Nr 1 im. Prof. S. Szyszko SUM w Katowicach Zabrze Poland Active Not Recruiting
Hospital Pediatrico - Unidade Local de Saude de Coimbra Coimbra Portugal Active Not Recruiting
Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE Lisbon Portugal Recruiting
Centro Materno Infantil do Norte - Unidade Local de Saude de Santo Antonio Porto Portugal Active Not Recruiting
"Emergency County Clinical Hospital ""Pius Brinzeu""" Timișoara Timiș County Active Not Recruiting
Dr Victor Gomoiu Clinical Children Hospital Bucharest Romania Recruiting
Spitalul Clinic de Urgenta Pentru Copii ,,Grigore Alexandrescu, Bucharest Romania Recruiting
University Children's Hospital Belgrade Serbia Recruiting
Mother and child helath care Institute of Serbia dr Vukan Cupic Belgrade Serbia Active Not Recruiting
Institute for Childand YouthHealth Care of Vojvodina Novi Sad Serbia Active Not Recruiting

+ 14 more sites — see the full list on the official registry below.

More Takeda trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06100289 on ClinicalTrials.gov ↗ ← All trials in the USA