This is a multicentre, randomised, double-blind, parallel-group, placebo-controlled, phase III study originally designed to test the hypothesis that benralizumab will reduce exacerbation rates compared with placebo on top of standard-of-care therapy in adult patients with non-cystic fibrosis bronchiectasis with eosinophilic inflammation (NCFB+EI). All patients who complete the double-blind treatment period (28 to 52 weeks depending on the timing of patient randomization and when the revised CSP version 3.0 becomes effective) on investigational product (IP) may be eligible to continue into an open-label extension (OLE) period during which all patients will receive benralizumab. The revised OLE period is intended to allow patients approximately 32 weeks of treatment with open label benralizumab (24 weeks followed by a FU visit 8 weeks after the last dose of IP for a total of approximately 32 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Benralizumab active solution in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume
Matching placebo solution in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume
Research Site
Birmingham, Alabama, United States
Research Site
Newport Beach, California, United States
Research Site
Northridge, California, United States
Research Site
El Paso, Texas, United States
Research Site
Florida, Argentina
Research Site
Annualized Bronchiectasis Exacerbations Rate in the Double-blind Period
Annualized Non-Cystic Fibrosis Bronchiectasis (NCFB) exacerbations rate through end of double-blind treatment period.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Time to First Exacerbation in the Double-blind Treatment Period
Time to first NCFB exacerbation in the double-blind treatment period
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B-RSS Over the Double-blind Period
Change from baseline in Quality of Life-Bronchiectasis-Respiratory Symptoms Scale over the double-blind treatment period. QoL-B-RSS scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in Pre-dose Pre-BD FEV1 Over the Double-blind Treatment Period
Change from baseline in pre-dose pre-bronchodilator (BD) forced expiratory volume in one second (FEV1) over the double-blind treatment period
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in LCQ Total Score Over the Double-blind Period
Change from baseline in Leicester Cough Questionnaire (LCQ) total score over the double-blind treatment period. LCQ total scores range from 3 to 21. Higher scores indicate better quality of life.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Physical Functioning Scale
change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Physical Functioning Scale. QoL-B Physical Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Role Functioning Scale
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Role Functioning Scale. QoL-B Role Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Emotional Functioning Scale
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Emotional Functioning Scale. QoL-B Emotional Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Social Functioning Scale
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Social Functioning Scale. QoL-B Social Functioning Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Vitality Scale
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Vitality Scale. QoL-B Vitality Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Health Perceptions Scale
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Health Perceptions Scale. QoL-B Health Perceptions Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in QoL-B Scales (Excluding QoL-B-RSS) Over the Double-blind Period: Treatment Burden Scale
Change from baseline in Quality of Life-Bronchiectasis (QoL-B) scales (excluding QoL-B-RSS) over the double-blind treatment period: Treatment Burden Scale. QoL-B Treatment Burden Scale scores range from 0 to 100, with higher scores indicative of better health-related quality of life.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
Change From Baseline in SGRQ Total Score Over the Double-blind Treatment Period
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score over the double-blind treatment period. SGRQ total scores range from 0 to 100. 100 represents the worst possible health status and 0 indicates the best possible health status.
Time frame: through Double-blind period, at least 28 weeks and up to 52 weeks
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San Fernando, Argentina
Research Site
San Miguel de Tucumán, Argentina
Research Site
Melbourne, Australia
Research Site
South Brisbane, Australia
Research Site
Ajax, Ontario, Canada
...and 38 more locations