Safety of Vedolizumab IV in Pediatric Subjects
Condition: Ulcerative colitis, Crohn's disease
Key Inclusion Criteria
- Male or female with UC or CD between 2-17 years old at the time of group assignment for study MLN0002-2003
- Completed study MLN0002-2003 and at week 22 of the study, achieved clinical response
Key Exclusion Criteria
- Lactating or pregnant
- Hypersensitivity or allergies to vedolizumab
- Has withdrawn from study MLN0002-2003
Full Study Name
Takeda - Vedolizumab Phase IIb Extension Study in Pediatric Patients With Ulcerative Colitis or Crohn's Disease (IRB no. 48104)
This study focuses on patients who have previously participated in the MLN0002-2003 study (A Phase II, 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). Researchers will evaluate the long-term safety of a drug called vedolizumab in children who have ulcerative colitis (UC) or Crohn's disease (CD). The study also aims to determine whether vedolizumab may help UC and CD symptoms, hospitalizations and quality of life in children, as well as how the drug is processed by the body in children. Additionally, participants will be asked to provide samples to help identify and confirm biomarkers. Biomarkers are biological or chemical "markers" that can be found in blood, stool, tissue, and other body fluids that may be a sign of a condition or disease.
The study is designed to test the investigational use of vedolizumab, which blocks the cells causing inflammation in the gut. Vedolizumab has only been tested in children who participated in the MLN0002-2003 research study.