A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
Status: Recruiting
Location: See all (54) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 17
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Phoenix Childrens Hospital
NOT_YET_RECRUITING
Phoenix
California
Loma Linda University
NOT_YET_RECRUITING
Loma Linda
Children's Hospital of Orange County
NOT_YET_RECRUITING
Orange
Stanford Children's Health
NOT_YET_RECRUITING
Palo Alto
Illinois
Advocate Children's Hospital Park Ridge
NOT_YET_RECRUITING
Park Ridge
Michigan
Childrens Hospital of Michigan
NOT_YET_RECRUITING
Detroit
New Jersey
Atlantic Health - Morristown Medical Center
NOT_YET_RECRUITING
Morristown
New York
New York Presbyterian Hospital
NOT_YET_RECRUITING
New York
Ohio
Cleveland Clinic
NOT_YET_RECRUITING
Cleveland
University Children's Clinic
NOT_YET_RECRUITING
Cleveland
Oklahoma
The University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Pennsylvania
Penn State Health Milton South Hershey Medical Center
NOT_YET_RECRUITING
Hershey
South Carolina
Medical University of South Carolina
NOT_YET_RECRUITING
Charleston
Washington
Multicare Health System Institute for Research and Innovation
NOT_YET_RECRUITING
Tacoma
Other Locations
Belgium
Cliniques Universitaires Saint-Luc
NOT_YET_RECRUITING
Brussels
Centre Hospitalier Chretien MontLegia
NOT_YET_RECRUITING
Liège
Bulgaria
UMHAT Sv. Georgi, EAD
RECRUITING
Plovdiv
Denmark
Hvidovre Hospital
NOT_YET_RECRUITING
Hvidovre
Ireland
Childrens Health Ireland at Crumlin - PIN
NOT_YET_RECRUITING
Crumlin
Italy
Azienda Ospedaliera Universitaria Gaetano Martino, Messina
NOT_YET_RECRUITING
Messina
ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi - INCIPIT - PIN
NOT_YET_RECRUITING
Milan
Unita Operativa Complessa Di Pediatria Medica
NOT_YET_RECRUITING
Pescara
Bambin Gesu Hospital - Ospedale Pediatrico Bambin Gesu
NOT_YET_RECRUITING
Roma
Japan
Juntendo University Hospital
RECRUITING
Bunkyo-ku
Kurume University Hospital
NOT_YET_RECRUITING
Kurume-shi
National Center for Child Health and Development
NOT_YET_RECRUITING
Setagaya-ku
Netherlands
Radboud Universitair Medisch Centrum
NOT_YET_RECRUITING
Nijmegen
Poland
Korczowski Bartosz, Gabinet Lekarski
RECRUITING
Rzeszów
Instytut Pomnik - Centrum Zdrowia Dziecka
RECRUITING
Warsaw
WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Warsaw
SPSK Nr 1 im. Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego
NOT_YET_RECRUITING
Zabrze
Portugal
Hospitais da Universidade de Coimbra
NOT_YET_RECRUITING
Coimbra
Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE
NOT_YET_RECRUITING
Lisbon
Centro Hospitalar do Porto - Hospital de Santo Antonio
NOT_YET_RECRUITING
Porto
Republic of Korea
Kyungpook National University Chilgok hospital
RECRUITING
Daegu
Samsung Medical Center
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Romania
Grigore Alexandrescu Emergency Clinical Hospital for Children
RECRUITING
Bucharest
Victor Gomoiu Clinical Hospital for Children
RECRUITING
Bucharest
Pius Brinzeu Emergency Clinical County Hospital
NOT_YET_RECRUITING
Timișoara
Serbia
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
NOT_YET_RECRUITING
Belgrade
University Children's Clinic
NOT_YET_RECRUITING
Belgrade
Institute for Children and Youth Health Care of Vojvodina
NOT_YET_RECRUITING
Novi Sad
Spain
Hospital Arquitecto Marcide de Ferrol
NOT_YET_RECRUITING
Ferrol
Hospital Universitario 12 de Octubre
NOT_YET_RECRUITING
Madrid
Hospital Universitario Virgen Macarena
NOT_YET_RECRUITING
Seville
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
NOT_YET_RECRUITING
Valencia
Switzerland
University Hospital of Bern
RECRUITING
Bern
Centre Hospitalier Universitaire Vaudois
NOT_YET_RECRUITING
Lausanne
University Children's Hospital Zurich
NOT_YET_RECRUITING
Zurich
Taiwan
Changhua Christian Medical Foundation - Changhua Christian Children's Hospital
NOT_YET_RECRUITING
Changhua
Kaohsiung Medical University - Chung-Ho Memorial Hospital
NOT_YET_RECRUITING
Kaohsiung City
National Taiwan University Hospital
NOT_YET_RECRUITING
Zhongzheng
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2025-10-27
Estimated Completion Date: 2030-08-12
Participants
Target number of participants: 70
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Takeda