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Study identifier: NCT06405087 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Ulcerative Colitis · Crohn's Disease  ·  Sponsor: Takeda

PhasePhase 3
Planned participants70
Who can joinAll sexes, 2 Years to 17 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Takeda Contact  ·  +1-877-825-3327  ·  medinfoUS@takeda.com

Always discuss trial participation with your own doctor first.

Locations (54)

Phoenix Childrens HospitalPhoenix, Arizona, United StatesNot Yet Recruiting
Loma Linda UniversityLoma Linda, California, United StatesNot Yet Recruiting
Children's Hospital of Orange CountyOrange, California, United StatesNot Yet Recruiting
Stanford Children's HealthPalo Alto, California, United StatesNot Yet Recruiting
Advocate Children's Hospital Park RidgePark Ridge, Illinois, United StatesNot Yet Recruiting
Childrens Hospital of MichiganDetroit, Michigan, United StatesNot Yet Recruiting
Atlantic Health - Morristown Medical CenterMorristown, New Jersey, United StatesNot Yet Recruiting
New York Presbyterian HospitalNew York, New York, United StatesNot Yet Recruiting
University Children's ClinicCleveland, Ohio, United StatesNot Yet Recruiting
Cleveland ClinicCleveland, Ohio, United StatesNot Yet Recruiting
The University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma, United StatesRecruiting
Penn State Health Milton South Hershey Medical CenterHershey, Pennsylvania, United StatesNot Yet Recruiting

+ 42 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06405087