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

May 14, 2026 updated by: Takeda

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
      • Liège, Belgium, 4000
        • Recruiting
        • Centre Hospitalier Chretien MontLegia
        • Principal Investigator:
          • Olivia Bauraind
        • Contact:
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • University Hospital "Saint George"
        • Principal Investigator:
          • Ivan Yankov
        • Contact:
  • Denmark
    • Capital Region
      • Hvidovre, Capital Region, Denmark, 2650
        • Active, not recruiting
        • Hvidovre University Hospital
  • Ireland
      • Dublin, Ireland, D12 N512
        • Active, not recruiting
        • Childrens Health Ireland
  • Italy
      • Messina, Italy, 98124
        • Recruiting
        • Azienda Ospedaliera Universitaria Gaetano Martino Messina
        • Principal Investigator:
          • Claudio Romano
        • Contact:
      • Milan, Italy, 20154
        • Recruiting
        • V. Buzzi Hospital
        • Principal Investigator:
          • Gian Vincenzo Zuccotti
        • Contact:
      • Pescara, Italy, 65125
        • Active, not recruiting
        • Unita Operativa Complessa Di Pediatria Medica
      • Rome, Italy, 00165
        • Active, not recruiting
        • IRCCS Ospedale Pediatrico Bambino Gesù
  • Japan
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Active, not recruiting
        • Kurume University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
        • Principal Investigator:
          • Takahiro Kudo
        • Contact:
      • Setagaya-Ku, Tokyo, Japan, 157-8535
        • Active, not recruiting
        • National Center for Child Health and Development (NCCHD)
  • Netherlands
      • Nijmegen, Netherlands, 6525 GA
        • Active, not recruiting
        • Radboud University Medical Center
  • Poland
      • Rzeszów, Poland, 35302
        • Recruiting
        • Korczowski Bartosz, Gabinet Lekarski
        • Principal Investigator:
          • Bartosz Korczowski
        • Contact:
      • Warsaw, Poland, 04-501
        • Recruiting
        • Medical Network Sp. Z.o.o. WIP Warsaw IBD Point Profesor Kierkus
        • Principal Investigator:
          • Monika Meglicka
        • Contact:
      • Zabrze, Poland, 41-800
        • Active, not recruiting
        • SPSK Nr 1 im. Prof. S. Szyszko SUM w Katowicach
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 04730
        • Recruiting
        • Instytut Pomnik - Centrum Zdrowia Dziecka
        • Principal Investigator:
          • Jaroslaw Kierkus
        • Contact:
  • Portugal
      • Coimbra, Portugal, 3000-602
        • Active, not recruiting
        • Hospital Pediatrico - Unidade Local de Saude de Coimbra
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE
        • Contact:
        • Principal Investigator:
          • Maria Helena Loreto
      • Porto, Portugal, 4050-165
        • Active, not recruiting
        • Centro Materno Infantil do Norte - Unidade Local de Saude de Santo Antonio
  • Romania
      • Bucharest, Romania, 022102
        • Recruiting
        • Dr Victor Gomoiu Clinical Children Hospital
        • Contact:
        • Principal Investigator:
          • Iulia Florentina Tincu
      • Bucharest, Romania, 11743
        • Recruiting
        • Spitalul Clinic de Urgenta Pentru Copii ,,Grigore Alexandrescu,
        • Contact:
        • Principal Investigator:
          • Cristina Becheanu
    • Timiș County
      • Timișoara, Timiș County, Romania, 300226
        • Active, not recruiting
        • "Emergency County Clinical Hospital ""Pius Brinzeu"""
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Children's Hospital
        • Principal Investigator:
          • Nina Ristic
        • Contact:
      • Belgrade, Serbia, 11070
        • Active, not recruiting
        • Mother and child helath care Institute of Serbia dr Vukan Cupic
      • Novi Sad, Serbia, 21000
        • Active, not recruiting
        • Institute for Childand YouthHealth Care of Vojvodina
  • South Korea
      • Daegu, South Korea, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital (KNUCH)
        • Principal Investigator:
          • Ben Kang
        • Contact:
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Jin Soo Moon
        • Contact:
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Principal Investigator:
          • Eunjoo Lee
        • Contact:
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Yon Ho Choe
        • Contact:
  • Spain
      • Ferrol, Spain, 15405
        • Active, not recruiting
        • Complejo Hospitalario Universitario de Ferrol
      • Madrid, Spain, 28041
        • Active, not recruiting
        • Hospital Universitario 12 de Octubre
      • Seville, Spain, 41009
        • Recruiting
        • Hospital U. Virgen Macarena
        • Contact:
        • Principal Investigator:
          • Federico Arguelles
      • Valencia, Spain, 46026
        • Active, not recruiting
        • Hospital Univesritario y Politecnico La Fe. Av Fernando abril Martorell106. Valencia 46026. Spain
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Inselspital, Universitatsspital Bern, Kinderklinik, Julie-von-Jenner-Haus
        • Principal Investigator:
          • Christiane Sokollik
        • Contact:
      • Zurich, Switzerland, 8008
        • Recruiting
        • Universitats-Kinderspital
        • Principal Investigator:
          • Carsten Posovszky
        • Contact:
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Switzerland, 1011
        • Recruiting
        • Centre Hospitalier Universitaire Vaudois (CHUV)
        • Contact:
        • Principal Investigator:
          • Andreas Nydegger
  • Taiwan
      • Changhua, Taiwan, 500010
        • Active, not recruiting
        • Changhua Christian Hospital
      • Kaohsiung City, Taiwan, 80756
        • Recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Hsiang-Hung Shih
    • Zhongzheng Dist
      • Taipei, Zhongzheng Dist, Taiwan, 100
        • Recruiting
        • National Taiwan University Children's Hospital
        • Principal Investigator:
          • Jia-Feng Wu
        • Contact:
          • Site Contact
          • Phone Number: +886 2 23123456 #271718
          • Email: wjf@ntu.edu.tw
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Not yet recruiting
        • Phoenix Children's Hospital
        • Principal Investigator:
          • Brad Pasternak
        • Contact:
    • California
      • Loma Linda, California, United States, 92354
        • Active, not recruiting
        • Loma Linda University School of Medicine
      • Orange, California, United States, 92868
        • Recruiting
        • Children's Hospital of Orange County
        • Contact:
        • Principal Investigator:
          • Kenneth Grant
      • Palo Alto, California, United States, 94304
        • Active, not recruiting
        • Stanford Children's Health
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Active, not recruiting
        • Advocate Children's Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Children's Hospital of Michigan
        • Contact:
        • Principal Investigator:
          • Kristen Cares
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Active, not recruiting
        • Atlantic Health System
    • New York
      • New York, New York, United States, 10065
        • Active, not recruiting
        • New York Presbyterian Hospital, Weill Cornell Medical College
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Active, not recruiting
        • University Hospitals Cleveland Medical Center
      • Cleveland, Ohio, United States, 44195
        • Active, not recruiting
        • Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • The University of Oklahoma Health Sciences Center
        • Principal Investigator:
          • Sirish Palle
        • Contact:
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Active, not recruiting
        • Penn State Health Milton S. Hershey Medical Center/ Penn State University College of Medicine
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Not yet recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Carmine Suppa
    • Washington
      • Tacoma, Washington, United States, 98405
        • Not yet recruiting
        • MultiCare Institute for Research & Innovation
        • Contact:
        • Principal Investigator:
          • Raghu Varier

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.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Vedolizumab IV
Vedolizumab IV injection.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
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.
Drug: Vedolizumab IV
Vedolizumab IV injection.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
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.
Drug: Vedolizumab IV
Vedolizumab IV injection.
Other Names:
  • MLN0002
  • ENTYVIO
  • KYNTELES
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.
Drug: Vedolizumab SC
Vedolizumab SC injection.
Other Names:
  • MLN0002SC
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.
Drug: Vedolizumab SC
Vedolizumab SC injection.
Other Names:
  • MLN0002SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Predose at Week 34
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
Multiple time points prior to Week 34; pre-dose at Week 34

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Baseline up to 18 weeks after last dose of study drug (up to Week 50)
Percentage of Participants with Positive Neutralizing AVA
Time Frame: Baseline up to 18 weeks after last dose of study drug (up to Week 50)
Baseline up to 18 weeks after last dose of study drug (up to Week 50)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

January 22, 2025

Primary Completion (Estimated)

November 15, 2027

Study Completion (Estimated)

November 15, 2027

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VedolizumabSC-3003
  • 2023-503188-40-00 (Ctis: Abbreviated EU CT Number)
  • jRCT2071240072 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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