Overview

This trial is active, not recruiting.

Condition asthma
Treatments benralizumab, benralizumab placebo, seasonal influenza virus vaccine
Phase phase 3
Sponsor AstraZeneca
Start date July 2016
End date January 2017
Trial size 100 participants
Trial identifier NCT02814643, D3250C00033

Summary

This is a randomized, double-blind, parallel group, placebo-controlled study designed to investigate the potential effect of a fixed dose of benralizumab administered subcutaneously (SC) on antibody responses following seasonal influenza virus vaccination

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
1 mL fill volume administered every 4 weeks for 3 doses (Weeks 0, 4, and 8). Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
benralizumab
Benralizumab SC administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).
seasonal influenza virus vaccine
Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
(Placebo Comparator)
1 mL fill volume administered every 4 weeks for 3 doses (Weeks 0, 4, and 8). Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
benralizumab placebo
Placebo administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).
seasonal influenza virus vaccine
Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.

Primary Outcomes

Measure
Post-dose strain-specific hemagglutination-inhibition (HAI) antibody geometric mean fold rises (GMFRs)
time frame: from week 8 to week 12
Post-dose strain-specific serum HAI antibody geometric meant titers (GMTs)
time frame: at week 12
Proportion of patients who experience a strain-specific post-dose antibody response with antibody response defined as a ≥4-fold rise in HAI antibody titer
time frame: from week 8 to week 12
Proportion of patients who achieve a strain-specific post-dose HAI antibody titer ≥40
time frame: at week 12

Secondary Outcomes

Measure
Proportion of patients who achieve a strain-specific post-dose HAI antibody titer ≥320
time frame: at week 12
Post-dose strain-specific microneutralization (MN) antibody GMFRs
time frame: from week 8 to week 12
Post-dose strain-specific serum MN GMTs obtained
time frame: at week 12
Proportion of patients who experience a strain-specific post-dose antibody response with antibody response defined as a ≥4-fold rise in MN antibody titer
time frame: from week 8 to week 12
Change from baseline in mean Asthma Control Questionnaire-6 (ACQ-6) score
time frame: at week 12

Eligibility Criteria

Male or female participants from 12 years up to 21 years old.

Inclusion Criteria: - Female and male patients aged 12 to 21 years, inclusive, at the time of Visit 1 - Weight of ≥40 kg - Documented history of current treatment with Inhaled corticosteroids (ICS) and long-acting β2 agonists (LABA) - Morning pre-bronchodilator forced expiratory volume in 1 second (FEV1) of >50% predicted at Visit 1 or Visit 2. - Airway reversibility (FEV1 >12% and 200 ml) demonstrated at Visit 1 or Visit 2 using the Maximum Post-bronchodilator Procedure OR - Airway reversibility documented in the previous 12 months prior to Visit 1 - An exacerbation, 1 or more, that required oral corticosteroids in the previous year OR - Any condition assessed by patient recall over the previous 2-4 weeks Exclusion Criteria: - Clinically important pulmonary disease other than asthma - Known history of allergy or reaction to the Investigational Product formulation or influenza vaccine - Receipt of an influenza vaccine within 90 days prior to randomization - Poorly controlled asthma during the screening period that requires treatment with oral corticosteroids or a hospitalization/emergency room visit for the treatment of asthma - Acute illness or evidence of significant active infection or known influenza infection during the current flu season

Additional Information

Official title A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe Asthma
Principal investigator Pamela L Zeitlin, M.D. Ph.D.
Description This study is designed to investigate the potential effect of benralizumab on the antibody response to the seasonal influenza virus vaccine in patients 12-21 years of age with asthma. Benralizumab will be given subcutaneously (SC) at Weeks 0, 4, and 8 weeks, at which time benralizumab levels will reach steady state. Patients will then receive 1 dose of intramuscular (IM) seasonal influenza virus vaccine at Week 8 and samples drawn at Week 8 and Week 12 to measure the antibody response to the influenza virus
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.