Severe Asthma Treatment with Benralizumab – Phase III

Pharmacokinetics and Pharmacodynamics and Long-term Safety of Benralizumab Administered Subcutaneously in Children with Severe Eosinophilic Asthma

Protocol Description

Through this multi-center study, researchers are investigating the use of benralizumab for safe treatment of severe uncontrolled asthmas in children. Researchers believe that benralizumab may help to prevent a signal (a protein made by the body called interleukin-5) that allows the formation and activation of eosinophils, a type of white blood cell that, when activated, can lead to uncontrolled asthma in some people.

Study Level: Phase III

Eligibility Criteria

Subject to exclusion criteria, this study is accepting participants ages 6 through 11 who have been diagnosed with child has severe uncontrolled asthma.
Boys and Girls: Ages 6 through 11

Requirements

Following a screening period, participants will receive the study drug by injection 4 times over 16 weeks, during which time researchers will study its effects and how the body processes it. Participants will continue to receive the drug 3 more times over an additional 32 weeks (total 48 weeks), while researchers study longer-term effects. A follow-up visit will occur within 4 weeks after the final dose of the study drug.
Visits: 14
Duration: 56 weeks from screening to follow-up (1 year, 1 month)

Status: Open to Enrollment

Source(s) of Support

AstraZeneca

Primary Investigator

Allyson Larkin, MD

Contact Information

For more information about the study or enrollment, please contact:
Linette Milkovich, RN
Clinical Research Coordinator Susan Richey, RN
412-692-6337