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

NCT06405087 · Takeda
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Official title
A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
About this study
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).
Eligibility criteria
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 design
Enrollment target: 70 participants
Allocation: randomized
Masking: none
Age groups: child
Timeline
Starts: 2025-10-27
Estimated completion: 2030-08-12
Last updated: 2026-06-22
Interventions
Drug: Vedolizumab SCOther: No Intervention
Primary outcomes
  • Treatment Cohort: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (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) (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 (Up to Week 86)
Sponsor
Takeda · industry
Contacts & investigators
ContactTakeda Contact · contact · medinfoUS@takeda.com · +1-877-825-3327
InvestigatorStudy Director · study_director, Takeda
All locations (54)
Phoenix Childrens HospitalNot Yet Recruiting
Phoenix, Arizona, United States
Loma Linda UniversityNot Yet Recruiting
Loma Linda, California, United States
Children's Hospital of Orange CountyNot Yet Recruiting
Orange, California, United States
Stanford Children's HealthNot Yet Recruiting
Palo Alto, California, United States
Advocate Children's Hospital Park RidgeNot Yet Recruiting
Park Ridge, Illinois, United States
Childrens Hospital of MichiganNot Yet Recruiting
Detroit, Michigan, United States
Atlantic Health - Morristown Medical CenterNot Yet Recruiting
Morristown, New Jersey, United States
New York Presbyterian HospitalNot Yet Recruiting
New York, New York, United States
University Children's ClinicNot Yet Recruiting
Cleveland, Ohio, United States
Cleveland ClinicNot Yet Recruiting
Cleveland, Ohio, United States
The University of Oklahoma Health Sciences CenterRecruiting
Oklahoma City, Oklahoma, United States
Penn State Health Milton South Hershey Medical CenterNot Yet Recruiting
Hershey, Pennsylvania, United States
Medical University of South CarolinaNot Yet Recruiting
Charleston, South Carolina, United States
Multicare Health System Institute for Research and InnovationNot Yet Recruiting
Tacoma, Washington, United States
Cliniques Universitaires Saint-LucNot Yet Recruiting
Brussels, Brussels Capital, Belgium
Centre Hospitalier Chretien MontLegiaNot Yet Recruiting
Liège, Belgium
UMHAT Sv. Georgi, EADRecruiting
Plovdiv, Bulgaria
Hvidovre HospitalNot Yet Recruiting
Hvidovre, Capital Region, Denmark
Childrens Health Ireland at Crumlin - PINNot Yet Recruiting
Crumlin, Dublin, Ireland
Azienda Ospedaliera Universitaria Gaetano Martino, MessinaNot Yet Recruiting
Messina, Italy
ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi - INCIPIT - PINNot Yet Recruiting
Milan, Italy
Unita Operativa Complessa Di Pediatria MedicaNot Yet Recruiting
Pescara, Italy
Bambin Gesu Hospital - Ospedale Pediatrico Bambin GesuNot Yet Recruiting
Roma, Italy
Kurume University HospitalNot Yet Recruiting
Kurume-shi, Fukuoka, Japan
Juntendo University HospitalRecruiting
Bunkyo-ku, Tokyo, Japan
National Center for Child Health and DevelopmentNot Yet Recruiting
Setagaya-ku, Tokyo, Japan
Radboud Universitair Medisch CentrumNot Yet Recruiting
Nijmegen, Netherlands
Korczowski Bartosz, Gabinet LekarskiRecruiting
Rzeszów, Poland
WIP Warsaw IBD Point Profesor KierkusRecruiting
Warsaw, Poland
Instytut Pomnik - Centrum Zdrowia DzieckaRecruiting
Warsaw, Poland
SPSK Nr 1 im. Prof.Stanislawa Szyszko Slaskiego Uniwersytetu MedycznegoNot Yet Recruiting
Zabrze, Poland
Hospitais da Universidade de CoimbraNot Yet Recruiting
Coimbra, Portugal
Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPENot Yet Recruiting
Lisbon, Portugal
Centro Hospitalar do Porto - Hospital de Santo AntonioNot Yet Recruiting
Porto, Portugal
Victor Gomoiu Clinical Hospital for ChildrenRecruiting
Bucharest, Bucharest, Romania
Pius Brinzeu Emergency Clinical County HospitalNot Yet Recruiting
Timișoara, Timiș County, Romania
Grigore Alexandrescu Emergency Clinical Hospital for ChildrenRecruiting
Bucharest, Romania
University Children's ClinicNot Yet Recruiting
Belgrade, Serbia
Mother and Child Health Care Institute of Serbia Dr Vukan CupicNot Yet Recruiting
Belgrade, Serbia
Institute for Children and Youth Health Care of VojvodinaNot Yet Recruiting
Novi Sad, Serbia
Kyungpook National University Chilgok hospitalRecruiting
Daegu, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Samsung Medical CenterNot Yet Recruiting
Seoul, South Korea
Hospital Arquitecto Marcide de FerrolNot Yet Recruiting
Ferrol, Spain
Hospital Universitario 12 de OctubreNot Yet Recruiting
Madrid, Spain
Hospital Universitario Virgen MacarenaNot Yet Recruiting
Seville, Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)Not Yet Recruiting
Valencia, Spain
University Hospital of BernRecruiting
Bern, Switzerland
Centre Hospitalier Universitaire VaudoisNot Yet Recruiting
Lausanne, Switzerland
University Children's Hospital ZurichNot Yet Recruiting
Zurich, Switzerland
Changhua Christian Medical Foundation - Changhua Christian Children's HospitalNot Yet Recruiting
Changhua, Taiwan
Kaohsiung Medical University - Chung-Ho Memorial HospitalNot Yet Recruiting
Kaohsiung City, Taiwan
National Taiwan University HospitalNot Yet Recruiting
Zhongzheng, Taiwan
A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD) · TrialPath