A randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of dupilumab in children 6 to less than 12 years of age with uncontrolled asthma
Sponsor: |
Sanofi US & Regeneron Pharmaceuticals Inc. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAR0975 |
U.S. Govt. ID: |
NCT02948959 |
Contact: |
Elizabeth Duverger: 929-280-5799 / ed2714@cumc.columbia.edu |
This study is designed to examine the efficacy and safety profile of dupilumab over one year in a population of asthmatic children in need for an additional treatment to their current maintenance management. Patients are randomized to either dupilumab or matching placebo administered standard care for a maximum treatment duration of 52 weeks. The investigator hopes to better understand the efficacy of dupilumab on multiple asthma domains including prevention of severe exacerbation, lung function, and symptom control. The short and long term effects on lung function and symptom control will be evaluated.
This study is closed
Investigator
Joyce Yu, MD
Is your child between age 6 and 11? |
Yes |
No |
Does your child have evidence of uncontrolled asthma? |
Yes |
No |
Does your child weigh less than 16 kg? |
Yes |
No |