A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease
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 |
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
Investigator
Joseph Picoraro, MD
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 |