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The purpose of this study is to determine whether Benralizumab reduces the exacerbation rate in patients with a history of asthma exacerbations and uncontrolled asthma receiving ICS-LABA with or without oral corticosteroids and additional asthma controllers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benralizumab 30 mg q.4 weeks | Experimental | Benralizumab administered subcutaneously every 4 weeks |
|
| Benralizumab 30 mg q.8 weeks | Experimental | Benralizumab administered subcutaneously every 8 weeks |
|
| Placebo | Placebo Comparator | Placebo administered subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benralizumab | Biological | Benralizumab subcutaneously on study week 0 until study week 52 inclusive. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL | The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF. | Immediately following the first administration of study drug through Study Week 56. |
| Measure | Description | Time Frame |
|---|---|---|
| Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL | The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF. | Immediately following the first administration of study drug through Study Week 56. |
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Inclusion Criteria:
Exclusion criteria:
Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study
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| Name | Affiliation | Role |
|---|---|---|
| Mark Fitzgerald, MD, PhD, Professor of Medicine | The Lung Centre, Gordon and Leslie Diamond Health Care Centre, Vancouver Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Andalusia | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35287231 | Derived | Menzies-Gow A, Hoyte FL, Price DB, Cohen D, Barker P, Kreindler J, Jison M, Brooks CL, Papeleu P, Katial R. Clinical Remission in Severe Asthma: A Pooled Post Hoc Analysis of the Patient Journey with Benralizumab. Adv Ther. 2022 May;39(5):2065-2084. doi: 10.1007/s12325-022-02098-1. Epub 2022 Mar 14. | |
| 32334141 | Derived |
| Label | URL |
|---|---|
| D3250C00018CSP3redacted | View source |
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2505 participants signed informed consent, 2181 entered screening/run-in period, 1306 participants were randomised to receive treatment with benralizumab 30 mg Q4W, Q8W, or placebo. Of the 1306 patients randomised, all (100.0%) received treatment with study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 weeks |
| FG001 | Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Biological | Placebo subcutaneously on study week 0 until study week 52 inclusive. |
|
| Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL | Immediately following the first administration of study drug through Study Week 56. |
| Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL | Immediately following the first administration of study drug through Study Week 56. |
| Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL | Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better. | Immediately following the first administration of study drug through Study Week 56. |
| Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL | Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better. | Immediately following the first administration of study drug through Study Week 56. |
| Change in Asthma Rescue Medication Use | Change from Baseline to Week 56 in number of Rescue medication use (puffs/day) | Immediately following the first administration of study drug through Study Week 56. |
| Home Lung Function Assessments Based on PEF | Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow [PEF]) | Immediately following the first administration of study drug through Study Week 56. |
| Proportion of Nights With Awakening Due to Asthma | Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma | Immediately following the first administration of study drug through Study Week 56. |
| Mean Change From Baseline to Week 56 in ACQ-6 for Patients With 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. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma. | Immediately following the first administration of study drug through Study Week 56. |
| Mean Change From Baseline to Week 56 in ACQ-6 for Patients With 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. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma. | Immediately following the first administration of study drug through Study Week 56. |
| Number of Patients With >=1 Asthma Exacerbation | Immediately following the first administration of study drug through Study Week 56 |
| Time to First Asthma Exacerbation | Immediately following the first administration of study drug through Study Week 56 |
| Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations | Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated) | Immediately following the first administration of study drug through Study Week 56. |
| Pharmacokinetics of Benralizumab | Mean PK Concentration at each visit | Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60 |
| Immunogenicity of Benralizumab | Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. | Pre-treatment until end of follow-up |
| Extent of Exposure | Extent of exposure is defined as the duration of treatment in days | Immediately following the first administration of study drug through Study Week 56 |
| Mean Change From Baseline to Week 56 in AQLQ(S)+12 | AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful. | Immediately following the first administration of study drug through Study Week 56 |
| Change From Baseline to Week 56 in EQ-5D-5L VAS | EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state. | Immediately following the first administration of study drug through Study Week 56 |
| Mean Work Productivity Loss Due to Asthma | WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. This is only applicable to patients who were employed. | Immediately following the first administration of study drug through Study Week 56 |
| Mean Productivity Loss Due to Asthma in Classroom | WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable for patients who took classes. | Immediately following the first administration of study drug through Study Week 56 |
| Number of Participants That Utilized Health Care Resources | Immediately following the first administration of study drug through Study Week 56 |
| Patient and Clinician Assessment of Response to Treatment | CGIC (clinician global impression of change), and PGIC (patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse). This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed. | Immediately following the first administration of study drug through Study Week 56 |
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| Lugogo NL, Kreindler JL, Martin UJ, Cook B, Hirsch I, Trudo FJ. Blood eosinophil count group shifts and kinetics in severe eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Aug;125(2):171-176. doi: 10.1016/j.anai.2020.04.011. Epub 2020 Apr 22. |
| 31836949 | Derived | Jackson DJ, Humbert M, Hirsch I, Newbold P, Garcia Gil E. Ability of Serum IgE Concentration to Predict Exacerbation Risk and Benralizumab Efficacy for Patients with Severe Eosinophilic Asthma. Adv Ther. 2020 Feb;37(2):718-729. doi: 10.1007/s12325-019-01191-2. Epub 2019 Dec 14. |
| 31626906 | Derived | Chipps BE, Hirsch I, Trudo F, Alacqua M, Zangrilli JG. Benralizumab efficacy for patients with fixed airflow obstruction and severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Jan;124(1):79-86. doi: 10.1016/j.anai.2019.10.006. Epub 2019 Oct 15. |
| 30802500 | Derived | Chupp G, Lugogo NL, Kline JN, Ferguson GT, Hirsch I, Goldman M, Zangrilli JG, Trudo F. Rapid onset of effect of benralizumab on morning peak expiratory flow in severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2019 May;122(5):478-485. doi: 10.1016/j.anai.2019.02.016. Epub 2019 Feb 23. |
| 30139780 | Derived | Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, Goldman M, Newbold P, Zangrilli JG. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018 Oct 18;52(4):1800936. doi: 10.1183/13993003.00936-2018. Print 2018 Oct. |
| 30077185 | Derived | DuBuske L, Newbold P, Wu Y, Trudo F. Seasonal variability of exacerbations of severe, uncontrolled eosinophilic asthma and clinical benefits of benralizumab. Allergy Asthma Proc. 2018 Sep 4;39(5):345-349. doi: 10.2500/aap.2018.39.4162. Epub 2018 Aug 4. |
| 29409951 | Derived | Chipps BE, Newbold P, Hirsch I, Trudo F, Goldman M. Benralizumab efficacy by atopy status and serum immunoglobulin E for patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2018 May;120(5):504-511.e4. doi: 10.1016/j.anai.2018.01.030. Epub 2018 Feb 1. |
| 29128192 | Derived | Ohta K, Adachi M, Tohda Y, Kamei T, Kato M, Mark Fitzgerald J, Takanuma M, Kakuno T, Imai N, Wu Y, Aurivillius M, Goldman M. Efficacy and safety of benralizumab in Japanese patients with severe, uncontrolled eosinophilic asthma. Allergol Int. 2018 Apr;67(2):266-272. doi: 10.1016/j.alit.2017.10.004. Epub 2017 Nov 8. |
| 27609406 | Derived | FitzGerald JM, Bleecker ER, Nair P, Korn S, Ohta K, Lommatzsch M, Ferguson GT, Busse WW, Barker P, Sproule S, Gilmartin G, Werkstrom V, Aurivillius M, Goldman M; CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor alpha monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2128-2141. doi: 10.1016/S0140-6736(16)31322-8. Epub 2016 Sep 5. |
| FG002 | Placebo | Placebo administered subcutaneously |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 weeks |
| BG001 | Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks |
| BG002 | Placebo | Placebo administered subcutaneously |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Gender | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils >=300/uL | The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF. | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS. | Posted | Least Squares Mean | 95% Confidence Interval | Events/year | Immediately following the first administration of study drug through Study Week 56. |
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| Secondary | Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Patients With Baseline Eosinophils <300/uL | The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF. | Full analysis set, Baseline eosinophils <300/uL, High-dose ICS. | Posted | Least Squares Mean | 95% Confidence Interval | Events/year | Immediately following the first administration of study drug through Study Week 56. |
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| Secondary | Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils >=300/uL | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS | Posted | Mean | Standard Deviation | Liter | Immediately following the first administration of study drug through Study Week 56. |
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| Secondary | Mean Change From Baseline to Week 56 in Pre-bronchodilator FEV1 (L) Value for Patients With Baseline Eosinophils <300/uL | Full analysis set, Baseline eosinophils <300/uL, High-dose ICS | Posted | Mean | Standard Deviation | Liter | Immediately following the first administration of study drug through Study Week 56. |
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| Secondary | Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils >=300/uL | Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better. | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS | Posted | Mean | Standard Deviation | Scores on a scale | Immediately following the first administration of study drug through Study Week 56. |
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| Secondary | Mean Change From Baseline to Week 56 Asthma Symptoms Score for Patients With Baseline Eosinophils <300/uL | Asthma symptoms during night time and daytime are recorded by the patient each morning and evening in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma). Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each timepoint is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better. | Full analysis set, Baseline eosinophils <300/uL, High-dose ICS | Posted | Mean | Standard Deviation | Scores on a scale | Immediately following the first administration of study drug through Study Week 56. |
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| Secondary | Change in Asthma Rescue Medication Use | Change from Baseline to Week 56 in number of Rescue medication use (puffs/day) | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS | Posted | Mean | Standard Deviation | Puffs per day | Immediately following the first administration of study drug through Study Week 56. |
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| Secondary | Home Lung Function Assessments Based on PEF | Change from Baseline to Week 56 in Home lung function (morning and evening Peak expiratory flow [PEF]) | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS | Posted | Mean | Standard Deviation | L/min | Immediately following the first administration of study drug through Study Week 56. |
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| Secondary | Proportion of Nights With Awakening Due to Asthma | Change from Baseline to Week 56 on Proportion of Nights with awakening due to asthma | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS | Posted | Mean | Standard Deviation | Proportion of nights | Immediately following the first administration of study drug through Study Week 56. |
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| Secondary | Mean Change From Baseline to Week 56 in ACQ-6 for Patients With 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. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma. | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS | Posted | Mean | Standard Deviation | Scores on a scale | Immediately following the first administration of study drug through Study Week 56. |
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| Secondary | Mean Change From Baseline to Week 56 in ACQ-6 for Patients With 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. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma. | Full analysis set, Baseline eosinophils <300/uL, High-dose ICS | Posted | Mean | Standard Deviation | Scores on a scale | Immediately following the first administration of study drug through Study Week 56. |
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| Secondary | Number of Patients With >=1 Asthma Exacerbation | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS | Posted | Number | Participants | Immediately following the first administration of study drug through Study Week 56 |
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| Secondary | Time to First Asthma Exacerbation | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS | Posted | Number | Participants | Immediately following the first administration of study drug through Study Week 56 |
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| Secondary | Annual Rate of Asthma Exacerbation Resulting Emergency Room Visits and Hospitalizations | Annual rate of asthma exacerbations that are associated with an emergency room visit or a hospitalization (adjudicated) | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS | Posted | Least Squares Mean | 95% Confidence Interval | Events/year | Immediately following the first administration of study drug through Study Week 56. |
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| Secondary | Pharmacokinetics of Benralizumab | Mean PK Concentration at each visit | PK analysis set | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Baseline, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48, Week 56, Week 60 |
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| Secondary | Immunogenicity of Benralizumab | Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post-baseline assessments (with >=16 weeks between first and last positive) or positive at last post-baseline assessment. Transiently positive is defined as having at least one post-baseline ADA positive assessment and not fulfilling the conditions of persistently positive. | Safety analysis set | Posted | Number | Participants | Pre-treatment until end of follow-up |
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| Secondary | Extent of Exposure | Extent of exposure is defined as the duration of treatment in days | Safety analysis set | Posted | Mean | Standard Deviation | Days | Immediately following the first administration of study drug through Study Week 56 |
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| Secondary | Mean Change From Baseline to Week 56 in AQLQ(S)+12 | AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful. | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS | Posted | Mean | Standard Deviation | Scores on a scale | Immediately following the first administration of study drug through Study Week 56 |
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| Secondary | Change From Baseline to Week 56 in EQ-5D-5L VAS | EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state. | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS | Posted | Mean | Standard Deviation | Scores on a scale | Immediately following the first administration of study drug through Study Week 56 |
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| Secondary | Mean Work Productivity Loss Due to Asthma | WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. This is only applicable to patients who were employed. | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS, who were employed | Posted | Mean | Standard Deviation | Percent of productivity loss | Immediately following the first administration of study drug through Study Week 56 |
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| Secondary | Mean Productivity Loss Due to Asthma in Classroom | WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable for patients who took classes. | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS, who took classes | Posted | Mean | Standard Deviation | percent of productivity loss | Immediately following the first administration of study drug through Study Week 56 |
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| Secondary | Number of Participants That Utilized Health Care Resources | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS | Posted | Number | Participants | Immediately following the first administration of study drug through Study Week 56 |
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| Secondary | Patient and Clinician Assessment of Response to Treatment | CGIC (clinician global impression of change), and PGIC (patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using a 7-point rating scale, ranging from 1 (Very much Improved), to 7 (Very much Worse). This endpoint was added after the second protocol amendment, thus not all patients had data to be analyzed. | Full analysis set, Baseline eosinophils >=300/uL, High-dose ICS | Posted | Number | Participants | Immediately following the first administration of study drug through Study Week 56 |
|
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Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Benralizumab 30 mg q.4 Weeks | Benralizumab administered subcutaneously every 4 weeks | 46 | 438 | 244 | 438 | ||
| EG001 | Benralizumab 30 mg q.8 Weeks | Benralizumab administered subcutaneously every 8 weeks | 41 | 428 | 232 | 428 | ||
| EG002 | Placebo | Placebo administered subcutaneously | 61 | 440 | 264 | 440 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rectal polyp | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatitis alcoholic | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis haemophilus | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cytomegalovirus hepatitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pseudomonas bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Anastomotic ulcer | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epiphysiolysis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Jaw cyst | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Colon neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nasal turbinate hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Parakeratosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urticaria papular | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
≥ 60 days prior to submission of material for publication/presentation, Institution and PI shall jointly provide AZ with material for review. No publication/presentation may include any of AZ's Confidential Information without AZ's written approval. AZ can request Inst. and PI to withhold material from submission for publication/presentation for an additional 90 days to allow AZ to establish and preserve its proprietary rights in the material being submitted for publication or presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mitchell Goldman, Medical Science Director | AstraZeneca | +1 301 398 0323 | Mitchell.Goldman@astrazeneca.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D008173 | Lung Diseases, Obstructive |
| ID | Term |
|---|---|
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571386 | benralizumab |
Not provided
Not provided
Not provided
| Male |
|
Model includes covariates treatment group, region, number of exacerbations in the previous year, and use of maintenance oral corticosteroids. |
| 0.019 |
| Rate Ratio |
| 0.72 |
| 2-Sided |
| 95 |
| 0.54 |
| 0.95 |
| No |
| Superiority or Other |
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