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Study identifier: NCT04779320 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

Condition: Crohn's Disease (CD)  ·  Sponsor: Takeda

PhasePhase 3
Planned participants120
Who can joinAll sexes, 2 Years to 17 Years
Healthy volunteersNo

About this study

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.

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 (96)

Phoenix Childrens HospitalPhoenix, Arizona, United StatesNot Yet Recruiting
Cedars Sinai Medical CenterLos Angeles, California, United StatesWithdrawn
Rady Childrens Hospital San Diego - PINSan Diego, California, United StatesNot Yet Recruiting
University of California San FranciscoSan Francisco, California, United StatesWithdrawn
I.H.S Health LLCKissimmee, Florida, United StatesWithdrawn
Childrens Center For Digestive HealthcareAtlanta, Georgia, United StatesRecruiting
Advocate Children's Hospital Park RidgePark Ridge, Illinois, United StatesRecruiting
Riley Hospital For ChildrenIndianapolis, Indiana, United StatesWithdrawn
Johns Hopkins UniversityBaltimore, Maryland, United StatesNot Yet Recruiting
Boston Children's HospitalBoston, Massachusetts, United StatesNot Yet Recruiting
MNGI Digestive Health, PAMinneapolis, Minnesota, United StatesRecruiting
Mayo Clinic - PINRochester, Minnesota, United StatesNot Yet Recruiting

+ 84 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04779320