RECRUITING

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

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Conditions

Ulcerative ColitisCrohn's DiseaseDrug Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-22
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06100289

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. The participant weighs ≥10 kg at the time of screening and enrollment into the study.
  2. 2. Participants with UC or CD diagnosed at least 1 month before screening. Participants with moderately to severely active disease defined as:
  3. * 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.)
  4. * 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.
  5. 3. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine \[AZA\], 6-mercaptopurine \[6-MP\], methotrexate \[MTX\]), and/or tumor necrosis factor (TNF)-α antagonist therapy (eg, infliximab, adalimumab).
  6. 4. Participants with evidence of UC extending proximal to the rectum (i.e., not limited to proctitis), at a minimum.
  7. 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.
  8. 6. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.
  1. 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. 2. Participants who have had prior exposure to vedolizumab.
  3. 3. Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.
  4. 4. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.
  5. 5. The participant has received any live vaccinations within 30 days before first dose of study drug.
  6. 6. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study.
  7. 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. 8. Participants with a current diagnosis of indeterminate colitis.
  9. 9. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD).
  10. 10. Participants with active or latent tuberculosis (TB).
  11. 11. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune subjects (ie, HBsAg negative and hepatitis B surface antibody \[anti-HBs\]-positive) may, however, be included.
  12. 12. The participant has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation).
  13. 13. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.
  14. 14. Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.

Contacts and Locations

Study Contact

Takeda Contact
CONTACT
+1-877-825-3327
medinfoUS@takeda.com

Principal Investigator

Study Director
STUDY_DIRECTOR
Takeda

Study Locations (Sites)

VVCRD Clinical Research
Garden Grove, California, 92845-2006
United States
Loma Linda University School of Medicine
Loma Linda, California, 92354
United States
Children's Hospital Of Orange County
Orange, California, 92868
United States
Stanford Children's Health
Palo Alto, California, 94304
United States
Advocate Children's Hospital
Park Ridge, Illinois, 60068
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Morristown Medical Center
Morristown, New Jersey, 07960
United States
The New York Presbyterian Hospital, Weill Cornell Medical College
New York, New York, 10021
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Medical University of South Carolina
North Charleston, South Carolina, 29406
United States

Collaborators and Investigators

Sponsor: Takeda

  • Study Director, STUDY_DIRECTOR, Takeda

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-22
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2025-01-22
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • Drug Therapy

Additional Relevant MeSH Terms

  • Ulcerative Colitis
  • Crohn's Disease