This is a randomised, double-blind, parallel group, placebo-controlled study designed to evaluate the efficacy and safety of a fixed 30 mg dose of benralizumab administered subcutaneously for patients with a history of asthma exacerbations and uncontrolled asthma receiving medium to high-dose inhaled corticosteroid plus long-acting β2-agonist (ICS-LABA) with or without oral corticosteroids and additional asthma controllers.
Approximately 666 patients will be randomised. Patients will be stratified by country/region, age group (adult or adolescent), and peripheral blood eosinophil count at time of Visit 1 (\<300 or ≥300 cells/μL).All the patients will be randomised to either placebo or benralizumab (1:1 ratio) for a 48-weeks treatment, every 4 weeks for the first 3 doses and then every 8 weeks thereafter.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
695
Benralizumab subcutaneously on study week 0 until study week 40 inclusive.
Placebo subcutaneously on study week 0 until study week 40 inclusive.
Annual Asthma Exacerbation Rate in Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma for Baseline Eosinophils >=300/uL
Annual asthma exacerbation rate over the 48-week treatment period among benralizumab and placebo groups
Time frame: From randomization through Study Week 48
Change From Baseline at Week 48 in Pre-bronchodilator FEV1 (L) Value for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Change from baseline at Week 48 in Pre-bronchodilator FEV1 (L)
Time frame: From randomization through Study Week 48
Change From Baseline at Week 48 in Total Asthma Symptom Score for for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Daytime and nighttime symptoms are reported using a response scale ranging from 0 to 3 where 0 indicates no asthma symptoms. The total asthma symptom score is the sum of the daytime and nighttime scores and ranges from 0 to 6; a decrease in score indicates symptom improvement.
Time frame: From randomization through Study Week 48
Change From Baseline at Week 48 in Total Asthma Rescue Medication Use for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Change from baseline at week 48 in total rescue medication use (number of puffs/day)
Time frame: From randomization through Study Week 48
Change From Baseline at Week 48 in Morning Peak Expiratory Flow (PEF) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Change from baseline at week 48 in morning PEF
Time frame: From randomization through Study Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Baotou, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Changsha, China
Research Site
Changzhi, China
Research Site
Chengdu, China
...and 69 more locations
Change From Baseline at Week 48 in Evening Peak Expiratory Flow (PEF) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Change from baseline at week 48 in evening PEF
Time frame: From randomization through Study Week 48
Change From Baseline at Week 48 in the Proportion of Night Awakening Due to Asthma and Requiring Rescue Medication for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Change from baseline at Week 48 in proportion of night awakening due to asthma and requiring rescue medication
Time frame: From randomization through Study Week 48
Change From Baseline at Week 48 in Asthma Control Questionnaire 6 (ACQ-6) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses.
Time frame: From randomization through Study Week 48
Time to First Asthma Exacerbation for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Time to first asthma exacerbation over 48-week treatment period
Time frame: From randomization through Study Week 48
Number and Percentage of Patients With >=1 Asthma Exacerbations Among Patients Who Were on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Number and percentage of patients with at least one exacerbation over 48-week treatment period
Time frame: From randomization through Study Week 48
Change From Baseline at Week 48 in Total Score of St. George's Respiratory Questionnaire (SGRQ) for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
The SGRQ is a 50-item PRO instrument developed to measure the HRQoL of patients with airway diseases. The questionnaire is divided into two parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The total score indicates the impact of disease on overall HRQoL. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible HRQoL and 0 indicates the best possible HRQoL.
Time frame: From randomization through Study Week 48
Annual Asthma Exacerbation Rate Associated With an Emergency Room/Urgent Care Visit or a Hospitalization for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Annual asthma exacerbation rate associated with an emergency room/urgent care visit or a hospitalization over 48-week treatment period
Time frame: From randomization through Study Week 48
Number and Percentages of Asthma Specific Health Care Resource Utilization for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Asthma specific health care resource utilization over 48-week treatment period.
Time frame: From randomization through Study Week 48
The Pharmacokinetics (PK) of Benralizumab as Assessed by Trough Concentration
PK trough concentrations at each visit
Time frame: week 0, week 24, week 48
The Immunogenicity of Benralizumab as Assessed by the Presence of Anti-drug Antibodies (ADAs)
Anti-drug antibodies (ADA) responses at baseline and post baseline.
Time frame: Pre-treatment until end of 48-week end of treatment
Percent Change From Baseline at Week 48 in Blood Eosinophil Levels for Patients on Medium to High-dose ICS-LABA With Uncontrolled Asthma and Baseline Eosinophils >=300/uL
Percent change from baseline at Week 48 in blood eosinophil levels
Time frame: From randomization through Study Week 48