Clinical research studies (also known as clinical trials) help make healthcare better. They do this by answering questions with the help of people like you. These might be about potential new medications, devices or procedures. For example:
- Does our study medication improve your condition?
- Does it cause any side effects?
- Does it work how we thought it would?
Each study is run by a team of doctors and nurses. This team follows a detailed plan. A group of scientists, lawyers and patients approve this plan before the study starts. Their job is to make sure that your health is the study’s top priority.
This is a randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of a fixed dose of benralizumab (30 mg) administered subcutaneously (SC) on antibody responses following seasonal influenza virus vaccination.
Approximately 100 patients 12-21 years of age with severe asthma will be randomized to receive SC benralizumab 30 mg or placebo administered at Weeks 0, 4, and 8.
After enrolment and confirmation of entry criteria, patients will proceed to a screening period of a minimum of 2 weeks to allow adequate time for all of the eligibility criteria to be evaluated before being randomized at Visit 3. Patients who continue to meet eligibility criteria will be randomized on Week 0 to receive 3 SC doses (at
Weeks 0, 4, and 8) of benralizumab 30 mg or placebo. Patients will receive 1 dose of seasonal influenza vaccine intramuscularly (IM) at Week 8. Serum samples for evaluation of antibody response will be drawn at Week 8 and Week12. An End of Treatment (EOT) will also be conducted at Week 12 and a Follow-up visit will be conducted at Week 20.
Patients will be maintained on their currently prescribed ICS-LABA therapy(ies) without change from enrollment throughout the screening and treatment period.
Male and female adolescent patients 12 to 21 years of age, inclusive, with severe asthma will be enrolled. Fifty percent or more of the patients will be 12 to 17 years of age.
Following enrolment, patients will enter a 2 to 4 week screening period followed by a 12-week double-blind, randomized treatment period, with the last dose of benralizumab/placebo administered at Week 8. An End of Treatment (EOT) will be conducted at Week 12 and a Follow-up visit will be conducted at Week 20.
The total planned study duration is a maximum of 24 weeks.