A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
Study of New Medical Therapy for Pediatric Crohn's Disease or Pediatric Ulcerative Colitis
Sponsor: Takeda
Enrolling: Male and Female Patients
Study Length: 32 Weeks
Clinic Visits: 8
IRB Number: AAAR5348
U.S. Govt. ID: NCT03138655
Contact: Elena Reynoso: 212-305-6274 / er2564@cumc.columbia.edu
Additional Study Information: New medical therapy for pediatric Crohn's disease (CD) or pediatric ulcerative colitis (UC). We are currently recruiting pediatric participants (aged 2 to 17 years) who have received a diagnosis of UC or CD but who do not tolerate or respond to standard treatments, including corticosteroids, immunomodulators and TNF-alpha antagonists. The hubble study will be investigating the pharmacokinetics, efficacy, immunogenicity, safety and tolerability of vedolizumab IV, administered by intravenous infusion in pediatric patients. As you may be aware, vedolizumab IV is already approved for use in adults with moderately to severely active UC or CD and has demonstrated significant and clinically relevant evidence of effectiveness in multiple clinical studies. Currently, no clinical data exists in pediatric patients, so this study hopes to investigate the dosing, efficacy and safety profile of vedolizumab IV in younger patients.
This study is closed
Joseph Picoraro, MD
Do You Qualify?
Is your child between 2 and 17 years of age? Yes No
Does your child weigh 10KG (22 pounds) or more? Yes No
Does your child have moderately to severely active ulcerative colitis or Crohn's disease? Yes No
Is your child no longer able to tolerate or respond to conventional therapies? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Elena Reynoso