A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
3 other identifiers
interventional
70
16 countries
54
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2025
Longer than P75 for phase_3
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2024
CompletedFirst Posted
Study publicly available on registry
May 8, 2024
CompletedStudy Start
First participant enrolled
October 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 12, 2030
June 22, 2026
June 1, 2026
4.8 years
May 3, 2024
June 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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)
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)
Observational Cohort: Number of Participants With Prespecified Safety Events
Prespecified safety events will include serious infections, malignancies, PML, concerns about growth and pubertal development, and bowel surgery.
Up to Week 86
Secondary Outcomes (2)
Treatment Cohort: Time to Major Inflammatory Bowel Disease (IBD)-related Events
Up to Week 120
Treatment Cohort: Change from Baseline in IMPACT-III Scores
Baseline, every 24 weeks in this study (up to Week 120)
Study Arms (3)
Treatment Cohort: Vedolizumab 108 mg PFS+AI
EXPERIMENTALVedolizumab 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.
Treatment Cohort: Vedolizumab 108 mg PFS+NSD
EXPERIMENTALVedolizumab 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.
Observational Cohort: Early Terminated Participants From Parent Study
OTHERParticipants 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.
Interventions
Vedolizumab subcutaneous injection.
As this is an observational cohort, no intervention will be administered.
Eligibility Criteria
You may qualify if:
- \. 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.
You may not qualify if:
- Has hypersensitivity or allergies to vedolizumab or any of its excipients.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (54)
Phoenix Childrens Hospital
Phoenix, Arizona, 85016, United States
Loma Linda University
Loma Linda, California, 92350, 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
Park Ridge, Illinois, 60068, United States
Childrens Hospital of Michigan
Detroit, Michigan, 48201, United States
Atlantic Health - Morristown Medical Center
Morristown, New Jersey, 07960, United States
New York Presbyterian Hospital
New York, New York, 10029, United States
University Children's Clinic
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Penn State Health Milton South Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Multicare Health System Institute for Research and Innovation
Tacoma, Washington, 98405, United States
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium
Centre Hospitalier Chretien MontLegia
Liège, Belgium
UMHAT Sv. Georgi, EAD
Plovdiv, 4002, Bulgaria
Hvidovre Hospital
Hvidovre, Capital Region, 2650, Denmark
Childrens Health Ireland at Crumlin - PIN
Crumlin, Dublin, Ireland
Azienda Ospedaliera Universitaria Gaetano Martino, Messina
Messina, 98124, Italy
ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi - INCIPIT - PIN
Milan, Italy
Unita Operativa Complessa Di Pediatria Medica
Pescara, 65125, Italy
Bambin Gesu Hospital - Ospedale Pediatrico Bambin Gesu
Roma, 165, Italy
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431, Japan
National Center for Child Health and Development
Setagaya-ku, Tokyo, 157-8535, Japan
Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA, Netherlands
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35-302, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501, Poland
Instytut Pomnik - Centrum Zdrowia Dziecka
Warsaw, Poland
SPSK Nr 1 im. Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego
Zabrze, Poland
Hospitais da Universidade de Coimbra
Coimbra, 3000-602, Portugal
Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE
Lisbon, 1649-035, Portugal
Centro Hospitalar do Porto - Hospital de Santo Antonio
Porto, 4099-001, Portugal
Victor Gomoiu Clinical Hospital for Children
Bucharest, Bucharest, Romania
Pius Brinzeu Emergency Clinical County Hospital
Timișoara, Timiș County, Romania
Grigore Alexandrescu Emergency Clinical Hospital for Children
Bucharest, Romania
University Children's Clinic
Belgrade, 11000, Serbia
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade, Serbia
Institute for Children and Youth Health Care of Vojvodina
Novi Sad, Serbia
Kyungpook National University Chilgok hospital
Daegu, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital Arquitecto Marcide de Ferrol
Ferrol, 15405, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, 46026, Spain
University Hospital of Bern
Bern, 03010, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011, Switzerland
University Children's Hospital Zurich
Zurich, 8032, Switzerland
Changhua Christian Medical Foundation - Changhua Christian Children's Hospital
Changhua, 500010, Taiwan
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
National Taiwan University Hospital
Zhongzheng, 100, Taiwan
Related Links
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2024
First Posted
May 8, 2024
Study Start
October 27, 2025
Primary Completion (Estimated)
August 12, 2030
Study Completion (Estimated)
August 12, 2030
Last Updated
June 22, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
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.