This study is currently not recruiting participants.

A Phase 2b Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

Study on Long-term Safety of Investigational Medication in Children with Ulcerative Colitis or Crohn's Disease

Not Recruiting
100 years or below
All
Phase N/A
1 Location

Brief description of study.

This extension study is intended to characterize the long-term safety profile of vedolizumab IV treatment in pediatric subjects with UC or CD who initiated treatment aged 2 to 17 years at the time of randomization in Study MLN0002-2003, and to describe the PK of a range of doses administered during the maintenance period (after clinical response to induction) and the correlation of the exposure to the drug with the clinical response.

Detailed description of study

This extension study is intended to characterize the long-term safety profile of vedolizumab IV treatment in pediatric subjects with UC or CD who initiated treatment aged 2 to 17 years at the time of randomization in Study MLN0002-2003, and to describe the PK of a range of doses administered during the maintenance period (after clinical response to induction) and the correlation of the exposure to the drug with the clinical response.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: ulcerative colitis,Crohn's disease
  • Age: 100 years or below
  • Gender: All

This study investigates the long-term safety of an investigational medication given through IV in children with Ulcerative Colitis (UC) or Crohn's Disease (CD). These conditions are types of inflammatory bowel diseases that cause inflammation in the digestive tract. The study focuses on children who started treatment between the ages of 2 and 17.

Participants will receive different doses of the investigational medication during the maintenance period, which follows the initial treatment phase. The study will examine how the amount of medication in the body relates to the participants' health outcomes. This helps to understand the medication's effects and safety over time.

  • Who can participate: Children aged 2 to 17 with Ulcerative Colitis or Crohn's Disease who have completed the initial study phase.
  • Study details: Participants will receive the investigational medication through an IV. The study will monitor the effects of different doses during the maintenance phase after initial treatment.
Updated on 19 Feb 2024. Study ID: 1711047338

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