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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Takeda • ClinicalTrials.gov ID: NCT06405087

Registry updated: 2026-10-09
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Description

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.

Interventions

  • Vedolizumab SC (Drug)
    Vedolizumab subcutaneous injection.
  • No Intervention (Other)
    As this is an observational cohort, no intervention will be administered.

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.

Conditions

Ulcerative Colitis Crohn's Disease

Locations

  • Phoenix Childrens Hospital — Phoenix, Arizona, United States
  • Loma Linda University — Loma Linda, California, United States
  • Children's Hospital of Orange County — Orange, California, United States
  • Advocate Children's Hospital Park Ridge — Park Ridge, Illinois, United States
  • Childrens Hospital of Michigan — Detroit, Michigan, United States
  • Atlantic Health - Morristown Medical Center — Morristown, New Jersey, United States
  • New York Presbyterian Hospital — New York, New York, United States
  • University Children's Clinic — Cleveland, Ohio, United States
  • Cleveland Clinic — Cleveland, Ohio, United States
  • The University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Penn State Health Milton South Hershey Medical Center — Hershey, Pennsylvania, United States
  • Medical University of South Carolina — Charleston, South Carolina, United States
  • Multicare Health System Institute for Research and Innovation — Tacoma, Washington, United States
  • Cliniques Universitaires Saint-Luc — Brussels, Brussels Capital, Belgium
  • Centre Hospitalier Chretien MontLegia — Liège, Belgium
  • UMHAT Sv. Georgi, EAD — Plovdiv, Bulgaria
  • Childrens Health Ireland at Crumlin - PIN — Crumlin, Dublin, Ireland
  • Azienda Ospedaliera Universitaria Gaetano Martino, Messina — Messina, Italy
  • ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi - INCIPIT - PIN — Milan, Italy
  • Unita Operativa Complessa Di Pediatria Medica — Pescara, Italy
  • Bambin Gesu Hospital - Ospedale Pediatrico Bambin Gesu — Roma, Italy
  • Kurume University Hospital — Kurume-shi, Fukuoka, Japan
  • Juntendo University Hospital — Bunkyo-ku, Tokyo, Japan
  • National Center for Child Health and Development — Setagaya-ku, Tokyo, Japan
  • Radboud Universitair Medisch Centrum — Nijmegen, Netherlands
  • Korczowski Bartosz, Gabinet Lekarski — Rzeszów, Poland
  • WIP Warsaw IBD Point Profesor Kierkus — Warsaw, Poland
  • Instytut Pomnik - Centrum Zdrowia Dziecka — Warsaw, Poland
  • 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, 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, South Korea
  • Seoul National University Hospital — Seoul, South Korea
  • Samsung Medical Center — Seoul, South Korea
  • Hospital Arquitecto Marcide de Ferrol — Ferrol, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Spain
  • Hospital Universitario Virgen Macarena — Seville, Spain
  • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur) — Valencia, Spain
  • University Hospital of Bern — Bern, Switzerland
  • Centre Hospitalier Universitaire Vaudois — Lausanne, Switzerland
  • University Children's Hospital Zurich — Zurich, Switzerland
  • Changhua Christian Medical Foundation - Changhua Christian Children's Hospital — Changhua, Taiwan
  • Kaohsiung Medical University - Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
  • National Taiwan University Hospital — Zhongzheng, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record