This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

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

18-75 Years
2 to 17 Years
All
All

Not accepting

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?

Yes

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.
No

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.

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Withdrawn
Withdrawn
Withdrawn
Withdrawn
Withdrawn
Terminated
Withdrawn
Withdrawn
Terminated
Withdrawn
Withdrawn
Withdrawn
Withdrawn
Withdrawn
Withdrawn
Withdrawn

For more information, view the full study details:

NCT047793202020-004301-31jRCT2071210031