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Monoclonal Antibodies

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

Phase 2

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has completed Study MLN0002-2003 and achieved clinical response as defined by specific criteria

Is male or female with UC or CD and was between 2 to 17 years, inclusive, at the time of randomization for Study MLN0002-2003

Must not have

Is female and is lactating or pregnant

Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist prior to the administration of the first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 8 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how safe it is to give the drug vedolizumab to children with either UC or CD over a long period of time.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not specified here, common side effects of Vedolizumab may include headache, joint pain, nausea, fever, infections, fatigue and infusion-related reactions such as redness or irritation at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant or breastfeeding.

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

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

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I have not developed any new, serious health issues recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)

Secondary study objectives

Change from Baseline in Body Mass Index (BMI) at Week 24 and Every 24 Weeks, Thereafter up to 8 Years

Change from Baseline in IMPACT-III Total and Subscale Scores at Week 24 and Every 24 weeks, Thereafter up to 8 Years

Height Velocity at Week 48 and Every 48 weeks, Thereafter up to 8 Years

+4 more

Side effects data

From 2019 Phase 4 trial • 11 Patients • NCT02559713

Colitis ulcerative

Gastrointestinal motility disorder

Viral infection

Crohn's disease

Paronychia

100%

80%

60%

40%

20%

Study treatment Arm

Vedolizumab 300 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vedolizumab

2009

Completed Phase 4

~10220

0 / 6Eligibility criteria met