Crohn’s Disease and Ulcerative Colitis Treatment with Vedolizumab – Phase II

Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease

Protocol Description

The purpose of this multi-center research study is to evaluate the effects of vedolizumab in children and teens with ulcerative colitis or Crohn’s disease. Researchers will be measuring the pharmacokinetics – how the body processes the drug – and its side effects, as well as its effectiveness at reducing symptoms. Vedolizumab was previously approved to reduce inflammation in adults with moderately to severely active Crohn’s disease or ulcerative colitis who have had an inadequate response to, loss of response to, or intolerance to conventional treatments.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, this study is accepting patients of both genders, ages 2 through 17 years, diagnosed with moderate to severe ulcerative colitis or moderate to severe Crohn’s disease.
Boys and Girls: Ages 2 through 17 years

Requirements

Participants will be randomly assigned into either a high-dose or low-dose group. They will receive the study drug via intravenous (IV) infusion at specific intervals four times during a 14-week period. More frequently participants will be seen for physical examinations, blood sampling and other tests. Participants may be invited to continue in an extension study for the study drug.
Visits: 10
Duration: About 40 weeks

Status: Open to Enrollment

Source(s) of Support

Takeda Development Center Americas

Primary Investigator

David Keljo, MD

Contact Information

For more information about the study or enrollment, please contact:
Amy Bookser, RN
412-692-8453