A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
Start Date
1/22/2025
Completion Date
11/15/2027
Summary
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.
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).
Eligibility Criteria
Age Range: 2 years to 17 years
Interventions
Vedolizumab IV
Vedolizumab SC
Conditions
Locations
Phoenix Children's Hospital
Phoenix, Arizona 85016
United States
Loma Linda University School of Medicine
Loma Linda, California 92354
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, Illinois 60068
United States
Children's Hospital of Michigan
Detroit, Michigan 48201
United States
Atlantic Health System
Morristown, New Jersey 07960
United States
New York Presbyterian Hospital, Weill Cornell Medical College
New York, New York 10065
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Penn State Health Milton S. Hershey Medical Center/ Penn State University College of Medicine
Hershey, Pennsylvania 17033
United States
Medical University of South Carolina
North Charleston, South Carolina 29406
United States
MultiCare Institute for Research & Innovation
Tacoma, Washington 98405
United States
Cliniques Universitaires Saint-Luc
Brussels, 1200
Belgium
Centre Hospitalier Chretien MontLegia
Liège, 4000
Belgium
University Hospital "Saint George"
Plovdiv, 4002
Bulgaria
Hvidovre University Hospital
Hvidovre, Capital Region 2650
Denmark
Childrens Health Ireland
Dublin, D12 N512
Ireland
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Messina, 98124
Italy
V. Buzzi Hospital
Milan, 20154
Italy
Unita Operativa Complessa Di Pediatria Medica
Pescara, 65125
Italy
IRCCS Ospedale Pediatrico Bambino Gesu
Rome, 00165
Italy
Kurume University Hospital
Kurume, Fukuoka 830-0011
Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo 113-8431
Japan
National Center for Child Health and Development (NCCHD)
Setagaya-Ku, Tokyo 157-8535
Japan
Radboud University Medical Center
Nijmegen, 6525 GA
Netherlands
Instytut Pomnik - Centrum Zdrowia Dziecka
Warsaw, Masovian Voivodeship 04730
Poland
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, 35302
Poland
Medical Network Sp. Z.o.o. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501
Poland
SPSK Nr 1 im. Prof. S. Szyszko SUM w Katowicach
Zabrze, 41-800
Poland
Hospital Pediatrico - Unidade Local de Saude de Coimbra
Coimbra, 3000-602
Portugal
Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE
Lisbon, 1649-035
Portugal
Centro Materno Infantil do Norte - Unidade Local de Saude de Santo Antonio
Porto, 4050-165
Portugal
"Emergency County Clinical Hospital ""Pius Brinzeu"""
Timișoara, Timiș County 300226
Romania
Dr Victor Gomoiu Clinical Children Hospital
Bucharest, 022102
Romania
Spitalul Clinic de Urgenta Pentru Copii ,,Grigore Alexandrescu,
Bucharest, 11743
Romania
University Children's Hospital
Belgrade, 11000
Serbia
Mother and child helath care Institute of Serbia dr Vukan Cupic
Belgrade, 11070
Serbia
Institute for Childand YouthHealth Care of Vojvodina
Novi Sad, 21000
Serbia
Kyungpook National University Chilgok Hospital (KNUCH)
Daegu, 41404
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Complejo Hospitalario Universitario de Ferrol
Ferrol, 15405
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital U. Virgen Macarena
Seville, 41009
Spain
Hospital Univesritario y Politecnico La Fe. Av Fernando abril Martorell106. Valencia 46026. Spain
Valencia, 46026
Spain
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud 1011
Switzerland
Inselspital, Universitatsspital Bern, Kinderklinik, Julie-von-Jenner-Haus
Bern, 3010
Switzerland
Universitats-Kinderspital
Zurich, 8008
Switzerland
National Taiwan University Children's Hospital
Taipei, Zhongzheng Dist 100
Taiwan
Changhua Christian Hospital
Changhua, 500010
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Taiwan