A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
Sponsored by Takeda
About this trial
Last updated 5 months ago
Study ID
MLN0002-3025
Status
Recruiting
Type
Interventional
Phase
Phase 3
Placebo
No
Accepting
2 to 17 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 4 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
Both boys and girls can take part.
Must be a child or teenager from 2 to 17 years old.
Must have moderate to severe Crohn’s disease.
Must have up-to-date vaccinations.
Exclusion Criteria
Cannot have previously been treated with vedolizumab or other anti-integrins. Examples are natalizumab, efalizumab, etrolizumab, or rituximab.
Additional entry criteria will be discussed with the study doctor.
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