Severe Asthma Treatment with Benralizumab – Phase III

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

Additional Information

Study Description at National Institutes of Health
Allergy and Immunology Research
Asthma Attack

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