Long-term Safety of Vedolizumab for Inflammatory Bowel Disease in Children

Recruiting in Palo Alto (17 mi)

+61 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Takeda

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this study is to determine the safety profile of long-term vedolizumab IV treatment in pediatric participants with UC or CD.

Eligibility Criteria

This trial is for children and teens aged 2-17 with Ulcerative Colitis or Crohn's Disease who have previously responded to Vedolizumab treatment. They must be up-to-date on vaccinations, may use certain antibiotics, and can continue in the study after turning 18 if eligible. Pregnant or lactating females, those with serious health issues, or allergies to Vedolizumab cannot participate.

Inclusion Criteria

I completed Study MLN0002-2003 and met its success criteria.

I was between 2 to 17 years old when I joined the MLN0002-2003 study for UC or CD.

Participant's vaccinations are up to date as per inclusion criteria number 10 in MLN0002-2003

+1 more

Exclusion Criteria

I am currently pregnant or breastfeeding.

I have symptoms that may suggest brain infection before starting the study drug.

I might need major surgery for my ulcerative colitis or Crohn's disease during the study.

+4 more

Participant Groups

The trial is testing the long-term safety of an IV medication called Vedolizumab in young patients with inflammatory bowel diseases like UC and CD. It aims to understand how safe it is when used over a longer period.

2Treatment groups

Experimental Treatment

Group I: Vedolizumab Low Dose GroupExperimental Treatment1 Intervention

Participants with UC or CD having baseline weight of \>= 30 kg will receive vedolizumab 150 mg and participants with UC or CD having baseline weight of \< 30 kg will receive vedolizumab 100 mg IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).

Group II: Vedolizumab High Dose GroupExperimental Treatment1 Intervention

Participants with UC or CD having baseline weight of greater than or equal to (\>=) 30 kilogram (kg) will receive vedolizumab 300 mg and participants with UC or CD having baseline weight of less than (\<) 30 kg will receive vedolizumab 200 mg, IV infusion, every 8 weeks until vedolizumab IV is commercially available for pediatric indication(s) in the participant's country or until other drug access programs become available (whichever comes first), the participant turns 18 years of age and can be transitioned to commercial drug (up to approximately 8 years).

Vedolizumab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Entyvio for: