A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)

June 18, 2026 updated by: Takeda

A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC.

In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 [NCT06100289]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study.

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 SC. Vedolizumab SC is being tested to treat pediatric participants with moderate to severe active UC or CD. This study will look at the long-term safety profile in pediatric participants who take vedolizumab SC.

The study will enroll approximately 70 participants. This extension study consists of a treatment cohort and an observational cohort. Participants will continue receiving the same dose and frequency of vedolizumab SC that was received at the last dose of the parent study VedolizumabSC-3003 (NCT06100289).

For the Treatment cohort participants will be randomized (1:1) to receive vedolizumab in either a prefilled syringe (PFS) as part of an autoinjector pen (PFS+AI) or a PFS with a needle safety device (PFS+NSD):

  • Treatment Cohort: Vedolizumab 108 milligram (mg) PFS+AI
  • Treatment Cohort: Vedolizumab 108 mg PFS+NSD

This multi-center trial will be conducted globally. The overall time to participate in this study is up to 2 years from the first dose in the study. Participants in the treatment cohort will have a follow-up safety visit of 18 weeks after their last dose of study drug. Participants who will not be eligible for the treatment cohort will be enrolled in the observational cohort and will be followed for approximately 2 years after the last dose of vedolizumab SC received during Study VedolizumabSC-3003 (NCT06100289).

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
      • Liège, Belgium
        • Not yet recruiting
        • Centre Hospitalier Chretien MontLegia
        • Contact:
        • Principal Investigator:
          • Stephanie Colinet
    • Brussels Capital
      • Brussels, Brussels Capital, Belgium
        • Not yet recruiting
        • Cliniques Universitaires Saint-Luc
        • Principal Investigator:
          • Isabelle Scheers
        • Contact:
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • UMHAT Sv. Georgi, EAD
        • Principal Investigator:
          • Ivan Yankov
        • Contact:
  • Denmark
    • Capital Region
      • Hvidovre, Capital Region, Denmark, 2650
  • Ireland
    • Dublin
      • Crumlin, Dublin, Ireland
        • Not yet recruiting
        • Childrens Health Ireland at Crumlin - PIN
        • Principal Investigator:
          • Seamus Hussey
        • Contact:
  • Italy
      • Messina, Italy, 98124
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria Gaetano Martino, Messina
        • Principal Investigator:
          • Claudio Romano
        • Contact:
      • Milan, Italy
        • Not yet recruiting
        • ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi - INCIPIT - PIN
        • Contact:
        • Principal Investigator:
          • Francesca Penagini
      • Pescara, Italy, 65125
        • Not yet recruiting
        • Unita Operativa Complessa Di Pediatria Medica
        • Contact:
        • Principal Investigator:
          • Maria Illiceto
      • Roma, Italy, 165
        • Not yet recruiting
        • Bambin Gesu Hospital - Ospedale Pediatrico Bambin Gesu
        • Contact:
        • Principal Investigator:
          • Paola Angelis
  • Japan
    • Fukuoka
      • Kurume-shi, Fukuoka, Japan, 830-0011
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital
        • Principal Investigator:
          • Takahiro Kudo
        • Contact:
      • Setagaya-ku, Tokyo, Japan, 157-8535
        • Not yet recruiting
        • National Center for Child Health and Development
        • Principal Investigator:
          • Katsuhiro Arai
        • Contact:
  • Netherlands
      • Nijmegen, Netherlands, 6525 GA
        • Not yet recruiting
        • Radboud Universitair Medisch Centrum
        • Principal Investigator:
          • Gerard Damen
        • Contact:
  • Poland
      • Rzeszów, Poland, 35-302
        • Recruiting
        • Korczowski Bartosz, Gabinet Lekarski
        • Principal Investigator:
          • Bartosz Korczowski
        • Contact:
      • Warsaw, Poland, 04-501
        • Recruiting
        • WIP Warsaw IBD Point Profesor Kierkus
        • Principal Investigator:
          • Monika Meglicka
        • Contact:
      • Warsaw, Poland
        • Recruiting
        • Instytut Pomnik - Centrum Zdrowia Dziecka
        • Principal Investigator:
          • Jaroslaw Kierkus
        • Contact:
      • Zabrze, Poland
        • Not yet recruiting
        • SPSK Nr 1 im. Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego
        • Principal Investigator:
          • Jaroslaw Kwiecien
        • Contact:
  • Portugal
      • Coimbra, Portugal, 3000-602
        • Not yet recruiting
        • Hospitais da Universidade de Coimbra
        • Principal Investigator:
          • Carla Maia
        • Contact:
      • Lisbon, Portugal, 1649-035
        • Not yet recruiting
        • Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE
        • Principal Investigator:
          • Maria Helena Loreto
        • Contact:
      • Porto, Portugal, 4099-001
        • Not yet recruiting
        • Centro Hospitalar do Porto - Hospital de Santo António
        • Principal Investigator:
          • Rosa Lima
        • Contact:
  • Romania
      • Bucharest, Romania
        • Recruiting
        • Grigore Alexandrescu Emergency Clinical Hospital for Children
        • Principal Investigator:
          • Cristina Becheanu
        • Contact:
    • Bucharest
      • Bucharest, Bucharest, Romania
        • Recruiting
        • Victor Gomoiu Clinical Hospital for Children
        • Principal Investigator:
          • Iulia Tincu
        • Contact:
    • Timiș County
      • Timișoara, Timiș County, Romania
        • Not yet recruiting
        • Pius Brinzeu Emergency Clinical County Hospital
        • Principal Investigator:
          • Corina Pienar
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11000
        • Not yet recruiting
        • University Children's Clinic
        • Principal Investigator:
          • Nina Ristic
        • Contact:
      • Belgrade, Serbia
        • Not yet recruiting
        • Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
        • Contact:
        • Principal Investigator:
          • Dragan Prokic
      • Novi Sad, Serbia
        • Not yet recruiting
        • Institute for Children and Youth Health Care of Vojvodina
        • Principal Investigator:
          • Mirjana Stojsic
        • Contact:
  • South Korea
      • Daegu, South Korea
        • Recruiting
        • Kyungpook National University Chilgok Hospital
        • Principal Investigator:
          • Ben Kang
        • Contact:
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Principal Investigator:
          • Eunjoo Lee
        • Contact:
      • Seoul, South Korea, 3080
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Jin Soo Moon
        • Contact:
      • Seoul, South Korea
        • Not yet recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Yon-Ho Choe
        • Contact:
  • Spain
      • Ferrol, Spain, 15405
        • Not yet recruiting
        • Hospital Arquitecto Marcide de Ferrol
        • Contact:
        • Principal Investigator:
          • Ana Piudo
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Enrique Medina Benitez
        • Contact:
      • Seville, Spain, 41009
        • Not yet recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
        • Principal Investigator:
          • Federico Argüelles-Arias
      • Valencia, Spain, 46026
        • Not yet recruiting
        • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
        • Contact:
        • Principal Investigator:
          • Ester Aliaga
  • Switzerland
      • Bern, Switzerland, 03010
        • Recruiting
        • University Hospital of Bern
        • Principal Investigator:
          • Christiane Sokollik
        • Contact:
      • Lausanne, Switzerland, 1011
        • Not yet recruiting
        • Centre hospitalier universitaire vaudois
        • Principal Investigator:
          • Andreas Nydegger
        • Contact:
      • Zurich, Switzerland, 8032
        • Not yet recruiting
        • University Children's Hospital Zurich
        • Principal Investigator:
          • Carsten Posovszky
        • Contact:
  • Taiwan
      • Changhua, Taiwan, 500010
        • Not yet recruiting
        • Changhua Christian Medical Foundation - Changhua Christian Children's Hospital
        • Contact:
        • Principal Investigator:
          • Fang_Ting Lu
      • Kaohsiung City, Taiwan, 807
        • Not yet recruiting
        • Kaohsiung Medical University - Chung-Ho Memorial Hospital
        • Principal Investigator:
          • Hsiang-Hung Shih
        • Contact:
      • Zhongzheng, Taiwan, 100
        • Not yet recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • Jia-Feng Wu
        • Contact:
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
    • California
      • Loma Linda, California, United States, 92350
        • Not yet recruiting
        • Loma Linda University
        • Principal Investigator:
          • Kaylan Parashette
        • Contact:
      • Orange, California, United States, 92868
        • Not yet recruiting
        • Children's Hospital of Orange County
        • Contact:
        • Principal Investigator:
          • Kenneth Grant
      • Palo Alto, California, United States, 94304
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Not yet recruiting
        • Advocate Children's Hospital Park Ridge
        • Principal Investigator:
          • Kiranmai Gorla
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Not yet recruiting
        • Childrens Hospital of Michigan
        • Contact:
        • Principal Investigator:
          • Renee Dass
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Not yet recruiting
        • Atlantic Health - Morristown Medical Center
        • Principal Investigator:
          • Alycia Leiby
        • Contact:
    • New York
      • New York, New York, United States, 10029
        • Not yet recruiting
        • New York Presbyterian Hospital
        • Principal Investigator:
          • Aliza Solomon
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Not yet recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Jacob Kuroswski
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • University Children's Clinic
        • Principal Investigator:
          • Thomas Sferra
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • The University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Sirish Palle
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Not yet recruiting
        • Penn State Health Milton South Hershey Medical Center
        • Contact:
        • Principal Investigator:
          • Stefany Garrity
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Not yet recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Carmine Suppa
    • Washington
      • Tacoma, Washington, United States, 98405
        • Not yet recruiting
        • Multicare Health System Institute For Research and 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 for Treatment Cohort 1. Has completed Week 34 of Study VedolizumabSC-3003 (NCT06100289) and achieved clinical response at Week 34 and was corticosteroid-free for at least the last 4 weeks (Week 30 to Week 34). Clinical response for participants with UC is defined as a reduction of partial Mayo score of >=2 points and >= 25 percentage (%) from baseline (from VedolizumabSC-3003 [NCT06100289]), including a >=1-point decrease in the Mayo stool frequency subscore and a >=1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of less than or equal to (<=) 1 point. Clinical response for participants with CD is defined as a pediatric Crohn's disease activity index (PCDAI) <=30 with a reduction in the PCDAI of >=15 points from baseline (from VedolizumabSC-3003 [NCT06100289]).

Inclusion Criteria for Observational Cohort

1. Has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 (NCT06100289) and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 (NCT06100289) but was not eligible to enroll in the treatment cohort of this study.

Exclusion Criteria for Treatment Cohort

  1. Has hypersensitivity or allergies to vedolizumab or any of its excipients.
  2. The participant currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Observational Cohort: Early Terminated Participants From Parent Study
Participants who receive any dose of vedolizumab SC during the parent study VedolizumabSC-3003 (NCT06100289) and are not eligible for the treatment cohort of this extension study (that is, participants who early terminated from parent study VedolizumabSC-3003 [NCT06100289] or did not achieve clinical response in the parent study or who received corticosteroids in the last 4 weeks of the parent study) will only be observed in the observational cohort of this study and will not receive any dose of the vedolizumab SC in this cohort.
Other: No Intervention
As this is an observational cohort, no intervention will be administered.
Experimental: Treatment Cohort: Vedolizumab 108 mg PFS+AI
Vedolizumab 108 mg, PFS+AI, subcutaneously, once every two weeks (Q2W) to the participants weighing greater than or equal to (>=) 30 kg and once every four weeks (Q4W) to the participants weighing >=10 to less than (<) 30 from Day 1 up to Week 120, until participant withdraws from the study, or until vedolizumab SC is commercially available for pediatric indication in the participant's country or other drug access programs become available, or the sponsor decides to close the study, whichever occurs first.
Drug: Vedolizumab SC
Vedolizumab subcutaneous injection.
Other Names:
  • MLN0002
Experimental: Treatment Cohort: Vedolizumab 108 mg PFS+NSD
Vedolizumab 108 mg, PFS+NSD, subcutaneously, Q2W to the participants weighing >=30 kg and Q4W to the participants weighing >=10 to <30 from Day 1 up to Week 120, until participant withdraws from the study, or until vedolizumab SC is commercially available for pediatric indication in the participant's country or other drug access programs become available, or the sponsor decides to close the study, whichever occurs first.
Drug: Vedolizumab SC
Vedolizumab subcutaneous injection.
Other Names:
  • MLN0002

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observational Cohort: Number of Participants With Prespecified Safety Events
Time Frame: Up to Week 86
Prespecified safety events will include serious infections, malignancies, PML, concerns about growth and pubertal development, and bowel surgery.
Up to Week 86
Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)
An Adverse event (AE) is defined as any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory value), symptom, or disease temporally associated with use of drug whether or not it is considered related to drug. SAE is defined as any untoward medical occurrence that at any dose: results in death, is life threatening.
First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)
Treatment Cohort: Number of Participants With Adverse Events of Special Interests (AESIs)
Time Frame: First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)
AESI is defined as infections, including opportunistic infection, such as progressive multifocal leukoencephalopathy (PML), liver injury, malignancies, injection-related reactions or systemic reactions including anaphylaxis and hypersensitivity reactions.
First dose of the study drug until 18 weeks of follow-up after last dose (up to Week 138)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events
Time Frame: Up to Week 120
Time to major IBD related events is defined as time to first occurrence of any among the 3 IBD related events such as: hospitalizations, surgeries, and procedures.
Up to Week 120
Treatment Cohort: Change from Baseline in IMPACT-III Scores
Time Frame: Baseline, every 24 weeks in this study (up to Week 120)
IMPACT-III questionnaire will be administered to participants aged 9 to 17 years. The IMPACT-III questionnaire is a self-reported measure with 35 closed questions encompassing 6 domains: Bowel Symptoms (7 items), Systemic Symptoms (3 items), Social Functioning (12 items), Body Image (3 items), Treatment/Interventions (3 items), and Emotional Functioning (7 items). The IMPACT-III uses a 5-point Likert subscale score ranging from 1 to 5 for all answers. The outcome total score ranges from 35 to 175, with higher scores suggesting better quality of life. Baseline refers to the Baseline of study VedolizumabSC-3003 (NCT06100289).
Baseline, every 24 weeks in this study (up to Week 120)

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)

October 27, 2025

Primary Completion (Estimated)

August 12, 2030

Study Completion (Estimated)

August 12, 2030

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 18, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VedolizumabSC-3004
  • 2023-508804-39-00 (Ctis: EU CT Number)
  • jRCT2031250519 (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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