This study is currently not recruiting participants.

A Phase 2 Randomized Double-Blind Dose-Ranging Study to Determine the Pharmacokinetics Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease

Investigating a Dose of Investigational Medication in Children with UC or CD

Not Recruiting
100 years or below
All
Phase N/A

Brief description of study.

A safe and effective dose for vedolizumab in children has yet to be determined. The aim of this phase 2 dose-ranging study is to evaluate vedolizumab PK in male and female pediatric subjects with moderately to severely active UC or CD. In addition, the dose-response at Week 14 in these subjects will be characterized to aid in dose selection for the pediatric phase 3 studies. PK, efficacy (including endoscopic assessment at Week 14), and safety assessments will be performed during the 22-week study.

Detailed description of study

A safe and effective dose for vedolizumab in children has yet to be determined. The aim of this phase 2 dose-ranging study is to evaluate vedolizumab PK in male and female pediatric subjects with moderately to severely active UC or CD. In addition, the dose-response at Week 14 in these subjects will be characterized to aid in dose selection for the pediatric phase 3 studies. PK, efficacy (including endoscopic assessment at Week 14), and safety assessments will be performed during the 22-week study.

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 effects of an investigational medication in children with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD). These are conditions where the immune system attacks the digestive tract, causing inflammation and discomfort. The purpose of this study is to find a safe and effective dose for children.

Participants will undergo various procedures including pharmacokinetic (PK) assessments, which measure how the drug moves through the body. There will also be checks on the effectiveness of the medication, such as endoscopic assessments, and safety evaluations over the course of the study.

  • Who can participate: Children aged 6 to 17 years with moderately to severely active UC or CD may be eligible to participate. Both male and female pediatric subjects are considered for this study.
  • Study details: Participants will receive the investigational medication and undergo assessments to measure its effects and safety. Some participants may receive a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine.
  • Study Timelines: The study will last 22 weeks.
Updated on 19 Feb 2024. Study ID: 1711969628

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