A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Recruiting · NCT06405087 · Interventional (participants receive a specific treatment) · Lead sponsor: Takeda
View the official record on ClinicalTrials.gov →Interventions studied
No InterventionVedolizumab SC
What this trial is about
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.
Who can take part
Age range
2 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
- \. 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
- 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.
Where it is running
60 locations listed across 11 US states.
- Phoenix Childrens Hospital - Phoenix, Arizona, United States
- Phoenix Childrens Hospital - Phoenix, Arizona, United States
- Loma Linda University - Loma Linda, California, United States
- Loma Linda University - Loma Linda, California, United States
- Children's Hospital of Orange County - Orange, California, United States
- Children's Hospital of Orange County - Orange, California, United States
- Stanford Children's Health - Palo Alto, California, United States
- Stanford Children's Health - Palo Alto, California, United States
- Advocate Children's Hospital Park Ridge - Park Ridge, Illinois, United States
- Advocate Children's Hospital Park Ridge - Park Ridge, Illinois, United States
- Childrens Hospital of Michigan - Detroit, Michigan, United States
- Childrens Hospital of Michigan - Detroit, Michigan, United States
- Atlantic Health - Morristown Medical Center - Morristown, New Jersey, United States
- Atlantic Health - Morristown Medical Center - Morristown, New Jersey, United States
- New York Presbyterian Hospital - New York, New York, 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
- 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
- The University of Oklahoma Health Sciences Center - Oklahoma City, Oklahoma, United States
- Penn State Health Milton South Hershey Medical Center - Hershey, Pennsylvania, United States
- Penn State Health Milton South Hershey Medical Center - Hershey, Pennsylvania, United States
- Medical University of South Carolina - Charleston, South Carolina, United States
- Medical University of South Carolina - Charleston, South Carolina, United States
- Multicare Health System Institute for Research and Innovation - Tacoma, Washington, United States
- Multicare Health System Institute for Research and Innovation - Tacoma, Washington, United States
- University Children's Clinic - Belgrade, Serbia
- Mother and Child Health Care Institute of Serbia Dr Vukan Cupic - Belgrade, Serbia
- University Children's Clinic - Belgrade, Serbia
- Mother and Child Health Care Institute of Serbia Dr Vukan Cupic - Belgrade, Serbia
- University Hospital of Bern - Bern, Switzerland
- University Hospital of Bern - Bern, Switzerland
- Grigore Alexandrescu Emergency Clinical Hospital for Children - Bucharest, Romania
- Grigore Alexandrescu Emergency Clinical Hospital for Children - Bucharest, Romania
- Changhua Christian Medical Foundation - Changhua Christian Children's Hospital - Changhua, Taiwan
- Changhua Christian Medical Foundation - Changhua Christian Children's Hospital - Changhua, Taiwan
- Hospitais da Universidade de Coimbra - Coimbra, Portugal
- Hospitais da Universidade de Coimbra - Coimbra, Portugal
- Kyungpook National University Chilgok hospital - Daegu, South Korea
- Kyungpook National University Chilgok hospital - Daegu, South Korea
- Hospital Arquitecto Marcide de Ferrol - Ferrol, Spain
- Hospital Arquitecto Marcide de Ferrol - Ferrol, Spain
- Kaohsiung Medical University - Chung-Ho Memorial Hospital - Kaohsiung City, Taiwan
- Kaohsiung Medical University - Chung-Ho Memorial Hospital - Kaohsiung City, Taiwan
- Centre Hospitalier Universitaire Vaudois - Lausanne, Switzerland
- Centre Hospitalier Universitaire Vaudois - Lausanne, Switzerland
- Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE - Lisbon, Portugal
- Hospital St Maria- Centro Hospitalar de Lisboa, Norte EPE - Lisbon, Portugal
- Centre Hospitalier Chretien MontLegia - Liège, Belgium
- Centre Hospitalier Chretien MontLegia - Liège, Belgium
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Azienda Ospedaliera Universitaria Gaetano Martino, Messina - Messina, Italy
- Azienda Ospedaliera Universitaria Gaetano Martino, Messina - Messina, Italy
- ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi - INCIPIT - PIN - Milan, Italy
- ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi - INCIPIT - PIN - Milan, Italy
- Radboud Universitair Medisch Centrum - Nijmegen, Netherlands
- Radboud Universitair Medisch Centrum - Nijmegen, Netherlands
Showing 60 of 108 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →