Crohn's Disease · Ulcerative Colitis
Vedolizumab for children with ulcerative colitis or Crohn's disease
This study is investigating vedolizumab in children and adolescents with ulcerative colitis or Crohn's disease, without assuming that the treatment will provide benefit.
Registry title: A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
6 recruiting U.S. sites ↓Study at a glance
- Age
- 2 Years–17 Years
- Treatment
- Vedolizumab IV or Vedolizumab SC
- Design
- Non Randomized
- Central study contact
- Takeda Contact+1-877-825-3327medinfoUS@takeda.com
- Sponsor
- Takeda
Research question
What does the study observe about vedolizumab when it is used in the pediatric population described in this protocol?
Participant snapshot
Who the study is looking for
- The study is looking for children and adolescents within the age range listed by the registry.
- The study is looking for participants with ulcerative colitis or Crohn's disease.
- The study team must confirm the diagnosis, disease characteristics, and treatment history against the full eligibility criteria.
Participation overview
What participation may involve
Participation may involve receiving vedolizumab and completing the protocol assessments used to evaluate study outcomes. What participation may involve: - Receive vedolizumab according to the assigned study regimen. - Complete assessments related to the study's reported outcome measures.
Study interventions
What participants may receive or do
- Vedolizumab: Participants may receive vedolizumab according to the study protocol.
Study design
How the comparison works
This is an interventional study evaluating vedolizumab in a pediatric population with ulcerative colitis or Crohn's disease.
Important unknowns
What the record does not make clear
- A complete visit-by-visit schedule is not provided in the registry record.
- The registry does not explain which study-related or routine-care costs are covered.
- The registry does not state whether participants or families receive compensation.
- The registry does not state whether transportation, lodging, meals, or other travel expenses are supported.
- The registry does not describe whether vedolizumab remains available through the study after participation ends.
- The registry lists locations with different recruitment statuses, so the overall study status does not confirm that a particular site is enrolling.
Before contacting the site
Questions for the study team
- What is the complete visit schedule, including visit length and which visits must occur in person?
- What vedolizumab dosing schedule and method of administration would apply to this participant?
- Which screening tests and study assessments are required, and which are research-only?
- Which current medicines may continue, and are any dose changes or washout periods required?
- Which costs are covered, and are compensation or travel and lodging support available?
- Is the relevant pediatric cohort currently enrolling at the location we could attend?
Before changing care
Questions for your gastroenterologist
- How stable is the child's ulcerative colitis or Crohn's disease now, and how might trial participation affect that stability?
- Would any current treatment need to change or stop under this protocol, and what clinical concerns would that raise?
- What approved treatment alternatives should we compare with this study?
- How should the gastroenterology team and research team coordinate routine care, monitoring, and management of a flare?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat pediatric participants with moderate to severe active UC or CD who achieved clinical response following open-label vedolizumab intravenous (IV) therapy. The study will look at the pharmacokinetics, safety, and immunogenicity of vedolizumab. The study will enroll approximately 70 patients. During the Induction Period participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline as: * Participants ≥30 kilograms (kg), Vedolizumab (High Dose) * Participants \>15 to \<30 kg, Vedolizumab (Medium Dose) * Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose) At Week 14, participants who achieve clinical response will be assigned to one of the following groups, stratified by weight to receive vedolizumab 108 mg SC injection during the 20-week Maintenance Period: * Participants ≥30 kg, Vedolizumab 108 mg once every 2 weeks (Q2W) * Participants ≥10 to \<30 kg, Vedolizumab 108 mg once every 4 weeks (Q4W) This multi-center trial will be conducted globally. After the Week 34 end of treatment (EOT) visit assessments have been completed, participants may be eligible to receive continued treatment with vedolizumab SC in an extension study, whereas participants who do not qualify to receive continued treatment in the extension study or participants who discontinue from the study for any reason will complete the EOT visit, and the follow-up safety visit (18 weeks after last dose).
Study design and administration
- Organization
- Takeda
- Organization class
- Industry
- Organization study ID
- VedolizumabSC-3003
- Lead sponsor
- Takeda
- Sponsor class
- Industry
- Enrollment type
- Estimated
- Allocation
- Non Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Child
Study arms
Experimental
Induction Period: Participants ≥30 kg, Vedolizumab (High Dose) IV
Participants weighing ≥30 kg will receive vedolizumab (High Dose) IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.
Interventions: Drug: Vedolizumab IV
Experimental
Induction Period: Participants >15 to <30 kg, Vedolizumab (Medium Dose) IV
Participants weighing \>15 to \<30 kg will receive vedolizumab (Medium Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.
Interventions: Drug: Vedolizumab IV
Experimental
Induction Period: Participants ≥10 to ≤15 kg, Vedolizumab (Low Dose) IV
Participants weighing ≥10 to ≤15 kg will receive vedolizumab (Low Dose), IV infusion, at Day 1, Weeks 2 and 6 in the Induction Period.
Interventions: Drug: Vedolizumab IV
Experimental
Maintenance Period: Participants ≥30 kg, Vedolizumab 108 mg SC Q2W
Participants with clinical response at Week 14 weighing ≥30 kg will receive vedolizumab 108 mg, SC injection, Q2W from Week 14 to Week 32 in the Maintenance Period.
Interventions: Drug: Vedolizumab SC
Experimental
Maintenance Period: Participants ≥10 to <30 kg, Vedolizumab 108 mg SC Q4W
Participants with clinical response at Week 14 weighing ≥10 to \<30 kg will receive vedolizumab 108 mg, SC injection, Q4W from Week 14 to Week 30 in the Maintenance Period.
Interventions: Drug: Vedolizumab SC
Interventions
Drug
Vedolizumab IV
Vedolizumab IV injection.
Drug
Vedolizumab SC
Vedolizumab SC injection.
Eligibility
2 Years–17 Years
All
Not accepted
Inclusion criteria (8)
- The participant weighs ≥10 kg at the time of screening and enrollment into the study.Registry-derived · unreviewed
- Participants with UC or CD diagnosed at least 1 month before screening. Participants with moderately to severely active disease defined as:Registry-derived · unreviewed
- 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.)Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- 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).Registry-derived · unreviewed
- Participants with evidence of UC extending proximal to the rectum (that is, not limited to proctitis), at a minimum.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.Registry-derived · unreviewed
Exclusion criteria (14)
- 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.Registry-derived · unreviewed
- Participants who have had prior exposure to vedolizumab.Registry-derived · unreviewed
- Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.Registry-derived · unreviewed
- Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.Registry-derived · unreviewed
- The participant has received any live vaccinations within 30 days before first dose of study drug.Registry-derived · unreviewed
- Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study.Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Participants with a current diagnosis of indeterminate colitis.Registry-derived · unreviewed
- Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD).Registry-derived · unreviewed
- Participants with active or latent tuberculosis (TB).Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- The participant has any identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, human immunodeficiency virus \[HIV\] infection, organ transplantation).Registry-derived · unreviewed
- Participants with positive stool studies for ova and/or parasites or stool culture at screening visit.Registry-derived · unreviewed
- Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Ctrough,ss: Steady-state Median Observed Plasma Concentration at the End of a Dosing Interval for Vedolizumab at Week 34
Time frame: Predose at Week 34
Primary outcome
Cavg,ss: Average Serum Concentration at Steady-state for Vedolizumab at Week 34
Time frame: Multiple time points prior to Week 34; pre-dose at Week 34
Secondary outcome
Percentage of Participants with Positive Antivedolizumab Antibody (AVA)
Time frame: Baseline up to 18 weeks after last dose of study drug (up to Week 50)
Secondary outcome
Percentage of Participants with Positive Neutralizing AVA
Time frame: Baseline up to 18 weeks after last dose of study drug (up to Week 50)
Recruiting locations in the United States
Phoenix Children's Hospital
Not Yet RecruitingPhoenix, Arizona, 85016, United States
Site Contact602-933-0674bpasternak@phoenixchildrens.com
Brad Pasternak
Children's Hospital Of Orange County
RecruitingOrange, California, 92868, United States
Site Contact714-509-4099kgrant@choc.org
Kenneth Grant
Children's Hospital of Michigan
RecruitingDetroit, Michigan, 48201, United States
Site Contact313-745-5585kcares@dmc.org
Kristen Cares
The University of Oklahoma Health Sciences Center
RecruitingOklahoma City, Oklahoma, 73104, United States
Site Contact405-271-5312Sirish-Palle@ouhsc.edu
Sirish Palle
Medical University of South Carolina
Not Yet RecruitingNorth Charleston, South Carolina, 29406, United States
Site Contact843-876-0444suppa@musc.edu
Carmine Suppa
MultiCare Institute for Research & Innovation
Not Yet RecruitingTacoma, Washington, 98405, United States
Site Contact253-792-6630ruvarier@multicare.org
Raghu Varier
This study also lists 40 locations outside the United States. They are not shown here.
Central study contacts
Registry dates
- First posted
- Oct 25, 2023
- Primary completion
- May 16, 2028
- Overall completion
- May 16, 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.