RecruitingPhase 3NCT06100289
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
Sponsor
Takeda
Enrollment
70 participants
Start Date
Jan 22, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 2 YearsMax Age: 17 Years
Inclusion Criteria8
- 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 Criteria14
- 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.
Interventions
DRUGVedolizumab IV
Vedolizumab IV injection.
DRUGVedolizumab SC
Vedolizumab SC injection.
Locations(57)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06100289
Related Trials
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
NCT0381634552 locations
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
NCT0609512849 locations
A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
NCT0658132891 locations
FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
NCT060713121 location
A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
NCT0604575454 locations