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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02258542




Registration number
NCT02258542
Ethics application status
Date submitted
1/09/2014
Date registered
7/10/2014
Date last updated
21/08/2019

Titles & IDs
Public title
A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA
Scientific title
A Multicentre, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting ß2 Agonist (BORA)
Secondary ID [1] 0 0
U1111-1162-2422
Secondary ID [2] 0 0
D3250C00021
Universal Trial Number (UTN)
Trial acronym
BORA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Benralizumab
Treatment: Other - Benralizumab

Experimental: Benralizumab Arm A - Benralizumab administered subcutaneously

Experimental: Benralizumab Arm B - Benralizumab administered subcutaneously


Treatment: Other: Benralizumab
Benralizumab administered subcutaneously

Treatment: Other: Benralizumab
Benralizumab administered subcutaneously
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients
Timepoint [1] 0 0
Week 56
Primary outcome [2] 0 0
Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Timepoint [2] 0 0
Week 108
Primary outcome [3] 0 0
Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients
Timepoint [3] 0 0
Week 56
Primary outcome [4] 0 0
Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Timepoint [4] 0 0
Week 108
Primary outcome [5] 0 0
Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients
Timepoint [5] 0 0
Week 56
Primary outcome [6] 0 0
Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Timepoint [6] 0 0
Week 108
Primary outcome [7] 0 0
Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients
Timepoint [7] 0 0
Week 56
Primary outcome [8] 0 0
Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Timepoint [8] 0 0
Week 108
Primary outcome [9] 0 0
Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients
Timepoint [9] 0 0
Week 56
Primary outcome [10] 0 0
Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Timepoint [10] 0 0
Week 108
Primary outcome [11] 0 0
Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients
Timepoint [11] 0 0
Week 56
Primary outcome [12] 0 0
Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Timepoint [12] 0 0
Week 108
Primary outcome [13] 0 0
Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients
Timepoint [13] 0 0
Week 56
Primary outcome [14] 0 0
Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Timepoint [14] 0 0
Week 108
Primary outcome [15] 0 0
Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients
Timepoint [15] 0 0
Week 56
Primary outcome [16] 0 0
Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)
Timepoint [16] 0 0
Week 108
Secondary outcome [1] 0 0
Number of Overall Patients With Asthma Exacerbations During Study Period
Timepoint [1] 0 0
From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)
Secondary outcome [2] 0 0
Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA)
Timepoint [2] 0 0
From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)
Secondary outcome [3] 0 0
Change From Baseline in Pre-bronchodilator FEV1 (L)
Timepoint [3] 0 0
Week 56
Secondary outcome [4] 0 0
Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
Timepoint [4] 0 0
Week 108
Secondary outcome [5] 0 0
Change From Baseline in Post-bronchodilator FEV1 (L)
Timepoint [5] 0 0
Week 56
Secondary outcome [6] 0 0
Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)
Timepoint [6] 0 0
Week 108
Secondary outcome [7] 0 0
Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients
Timepoint [7] 0 0
Week 56
Secondary outcome [8] 0 0
Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA)
Timepoint [8] 0 0
Week 108
Secondary outcome [9] 0 0
Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12)
Timepoint [9] 0 0
Week 56
Secondary outcome [10] 0 0
Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA)
Timepoint [10] 0 0
Week 108
Secondary outcome [11] 0 0
Change of Blood Eosinophil Levels' Measurement in Overall Patients
Timepoint [11] 0 0
Week 56
Secondary outcome [12] 0 0
Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA).
Timepoint [12] 0 0
Week 108
Secondary outcome [13] 0 0
Change From Baseline in EQ-5D-5L Visual Analog Scale
Timepoint [13] 0 0
Week 56
Secondary outcome [14] 0 0
Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA)
Timepoint [14] 0 0
Week 108
Secondary outcome [15] 0 0
Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI)
Timepoint [15] 0 0
Week 68
Secondary outcome [16] 0 0
Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
Timepoint [16] 0 0
Week 108
Secondary outcome [17] 0 0
Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ)
Timepoint [17] 0 0
Week 56
Secondary outcome [18] 0 0
Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA)
Timepoint [18] 0 0
Week 108
Secondary outcome [19] 0 0
Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI)
Timepoint [19] 0 0
Week 68
Secondary outcome [20] 0 0
Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)
Timepoint [20] 0 0
Week 108
Secondary outcome [21] 0 0
Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period
Timepoint [21] 0 0
From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose)
Secondary outcome [22] 0 0
Number of Patients Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period, Adolescents Only (SIROCCO/CALIMA)
Timepoint [22] 0 0
Baseline and Week 108
Secondary outcome [23] 0 0
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study
Timepoint [23] 0 0
Week 0 and Week 56
Secondary outcome [24] 0 0
Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA)
Timepoint [24] 0 0
Baseline and Week 108
Secondary outcome [25] 0 0
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study
Timepoint [25] 0 0
From week 0 to week 56 in study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period
Secondary outcome [26] 0 0
Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA)
Timepoint [26] 0 0
From week 0 to week 108 study treatment period (adults) and plus 16 weeks the follow up period; From week 0 to week 108-week in study treatment period (adolescents) and plus 16 weeks the follow up period

Eligibility
Key inclusion criteria
Inclusion criteria

1. Informed consent (and/or assent as applicable locally) for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent(s)/guardian(s)) and according to international guidelines and/or applicable European Union guidelines.
2. Female and male patients who completed the double-blind treatment period in a predecessor study on benralizumab or matching placebo.
3. Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after last dose of Investigational Product (IP).
4. For WOCBP only: Have a negative urine pregnancy test prior to administration of Investigational Product (IP) at Visit 1.
5. All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose.
Minimum age
12 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria

1. 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:

* Affect the safety of the patient throughout the study
* Influence the findings of the studies or their interpretations
* Impede the patient's ability to complete the entire duration of study
2. A helminth parasitic infection diagnosed during a predecessor study that has either not been treated, has been incompletely treated or has failed to respond to standard of care therapy
3. Any clinically significant change in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during a predecessor study 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 interfere with the patient's ability to complete the entire duration of the study
4. Current malignancy or malignancy that developed during a predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded).
5. Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last dose of the investigational product
6. Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
7. Planned major surgical procedures during the conduct of the study
8. Previous participation in the present study
9. Concurrent enrolment in another clinical trial
10. AstraZeneca staff involved in the planning and/or conduct of the study
11. Employees of the study centre or any other individuals involved with the conduct of the study or immediate family members of such individuals
12. Patients with major protocol deviations in any of the predecessor studies at the discretion of the Sponsor

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/07/2018
Sample size
Target
Accrual to date
Final
2133
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - Box Hill
Recruitment hospital [3] 0 0
Research Site - Clayton
Recruitment hospital [4] 0 0
Research Site - Concord
Recruitment hospital [5] 0 0
Research Site - Frankston
Recruitment hospital [6] 0 0
Research Site - Nedlands
Recruitment hospital [7] 0 0
Research Site - New Lambton Heights
Recruitment hospital [8] 0 0
Research Site - Parkville
Recruitment hospital [9] 0 0
Research Site - Prahran
Recruitment hospital [10] 0 0
Research Site - Randwick
Recruitment hospital [11] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
2139 - Concord
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
3004 - Prahran
Recruitment postcode(s) [10] 0 0
2031 - Randwick
Recruitment postcode(s) [11] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
Country [18] 0 0
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New Jersey
Country [19] 0 0
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New Mexico
Country [20] 0 0
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New York
Country [21] 0 0
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North Carolina
Country [22] 0 0
United States of America
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Ohio
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Oklahoma
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Pennsylvania
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Rhode Island
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South Carolina
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South Dakota
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Texas
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Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Wisconsin
Country [32] 0 0
Argentina
State/province [32] 0 0
Buenos Aires
Country [33] 0 0
Argentina
State/province [33] 0 0
Caba
Country [34] 0 0
Argentina
State/province [34] 0 0
Ciudad Autónoma de Bs. As.
Country [35] 0 0
Argentina
State/province [35] 0 0
Concepción del Uruguay
Country [36] 0 0
Argentina
State/province [36] 0 0
Corrientes
Country [37] 0 0
Argentina
State/province [37] 0 0
Córdoba
Country [38] 0 0
Argentina
State/province [38] 0 0
Florida
Country [39] 0 0
Argentina
State/province [39] 0 0
Godoy Cruz
Country [40] 0 0
Argentina
State/province [40] 0 0
La Plata
Country [41] 0 0
Argentina
State/province [41] 0 0
Mar del Plata
Country [42] 0 0
Argentina
State/province [42] 0 0
Mendoza
Country [43] 0 0
Argentina
State/province [43] 0 0
Nueve de julio
Country [44] 0 0
Argentina
State/province [44] 0 0
Ranelagh
Country [45] 0 0
Argentina
State/province [45] 0 0
Rosario
Country [46] 0 0
Argentina
State/province [46] 0 0
San Miguel de Tucuman
Country [47] 0 0
Brazil
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Porto Alegre
Country [48] 0 0
Brazil
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Santo Andre
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Brazil
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Sao Paulo
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Brazil
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Sorocaba
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Brazil
State/province [51] 0 0
São Paulo
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Bulgaria
State/province [52] 0 0
Dupnitsa
Country [53] 0 0
Bulgaria
State/province [53] 0 0
Pazardzhik
Country [54] 0 0
Bulgaria
State/province [54] 0 0
Pernik
Country [55] 0 0
Bulgaria
State/province [55] 0 0
Petrich
Country [56] 0 0
Bulgaria
State/province [56] 0 0
Pleven
Country [57] 0 0
Bulgaria
State/province [57] 0 0
Ruse
Country [58] 0 0
Bulgaria
State/province [58] 0 0
Samokov
Country [59] 0 0
Bulgaria
State/province [59] 0 0
Sliven
Country [60] 0 0
Bulgaria
State/province [60] 0 0
Sofia
Country [61] 0 0
Bulgaria
State/province [61] 0 0
Stara Zagora
Country [62] 0 0
Bulgaria
State/province [62] 0 0
Varna
Country [63] 0 0
Bulgaria
State/province [63] 0 0
Velingrad
Country [64] 0 0
Bulgaria
State/province [64] 0 0
Vratsa
Country [65] 0 0
Bulgaria
State/province [65] 0 0
Yambol
Country [66] 0 0
Canada
State/province [66] 0 0
Alberta
Country [67] 0 0
Canada
State/province [67] 0 0
British Columbia
Country [68] 0 0
Canada
State/province [68] 0 0
Ontario
Country [69] 0 0
Canada
State/province [69] 0 0
Quebec
Country [70] 0 0
Chile
State/province [70] 0 0
Quillota
Country [71] 0 0
Chile
State/province [71] 0 0
Santiago
Country [72] 0 0
Chile
State/province [72] 0 0
Talcahuano
Country [73] 0 0
Chile
State/province [73] 0 0
Valparaiso
Country [74] 0 0
Chile
State/province [74] 0 0
Viña del Mar
Country [75] 0 0
Czechia
State/province [75] 0 0
Jindrichuv Hradec
Country [76] 0 0
Czechia
State/province [76] 0 0
Karlovy Vary
Country [77] 0 0
Czechia
State/province [77] 0 0
Ostrava
Country [78] 0 0
Czechia
State/province [78] 0 0
Plzen
Country [79] 0 0
Czechia
State/province [79] 0 0
Praha
Country [80] 0 0
Czechia
State/province [80] 0 0
Rokycany
Country [81] 0 0
Czechia
State/province [81] 0 0
Strakonice
Country [82] 0 0
Czechia
State/province [82] 0 0
Teplice
Country [83] 0 0
France
State/province [83] 0 0
Brest Cedex
Country [84] 0 0
France
State/province [84] 0 0
Dijon Cedex
Country [85] 0 0
France
State/province [85] 0 0
Le Kremlin Bicêtre
Country [86] 0 0
France
State/province [86] 0 0
Le Mans Cedex
Country [87] 0 0
France
State/province [87] 0 0
Lyon Cedex 4
Country [88] 0 0
France
State/province [88] 0 0
Marseille
Country [89] 0 0
France
State/province [89] 0 0
Montpellier
Country [90] 0 0
France
State/province [90] 0 0
Paris
Country [91] 0 0
France
State/province [91] 0 0
Pau Cedex
Country [92] 0 0
France
State/province [92] 0 0
Pringy Cedex
Country [93] 0 0
France
State/province [93] 0 0
Saint Pierre
Country [94] 0 0
France
State/province [94] 0 0
Strasbourg Cedex
Country [95] 0 0
France
State/province [95] 0 0
Toulouse CEDEX 09
Country [96] 0 0
Germany
State/province [96] 0 0
Aschaffenburg
Country [97] 0 0
Germany
State/province [97] 0 0
Bamberg
Country [98] 0 0
Germany
State/province [98] 0 0
Berlin
Country [99] 0 0
Germany
State/province [99] 0 0
Bonn
Country [100] 0 0
Germany
State/province [100] 0 0
Frankfurt am Main
Country [101] 0 0
Germany
State/province [101] 0 0
Frankfurt/Main
Country [102] 0 0
Germany
State/province [102] 0 0
Frankfurt
Country [103] 0 0
Germany
State/province [103] 0 0
Geesthacht
Country [104] 0 0
Germany
State/province [104] 0 0
Grosshansdorf
Country [105] 0 0
Germany
State/province [105] 0 0
Hamburg
Country [106] 0 0
Germany
State/province [106] 0 0
Hannover
Country [107] 0 0
Germany
State/province [107] 0 0
Herford
Country [108] 0 0
Germany
State/province [108] 0 0
Leipzig
Country [109] 0 0
Germany
State/province [109] 0 0
Mainz Am Rhein
Country [110] 0 0
Germany
State/province [110] 0 0
München
Country [111] 0 0
Germany
State/province [111] 0 0
Neu-Isenburg
Country [112] 0 0
Germany
State/province [112] 0 0
Rostock
Country [113] 0 0
Germany
State/province [113] 0 0
Rüdersdorf
Country [114] 0 0
Germany
State/province [114] 0 0
Witten
Country [115] 0 0
Japan
State/province [115] 0 0
Asahi-shi
Country [116] 0 0
Japan
State/province [116] 0 0
Chiyoda-ku
Country [117] 0 0
Japan
State/province [117] 0 0
Chuo-ku
Country [118] 0 0
Japan
State/province [118] 0 0
Fukuoka-shi
Country [119] 0 0
Japan
State/province [119] 0 0
Hiroshima-shi
Country [120] 0 0
Japan
State/province [120] 0 0
Itabashi-ku
Country [121] 0 0
Japan
State/province [121] 0 0
Kagoshima-shi
Country [122] 0 0
Japan
State/province [122] 0 0
Kishiwada-shi
Country [123] 0 0
Japan
State/province [123] 0 0
Kobe-shi
Country [124] 0 0
Japan
State/province [124] 0 0
Kokubunji-shi
Country [125] 0 0
Japan
State/province [125] 0 0
Matsue-shi
Country [126] 0 0
Japan
State/province [126] 0 0
Minato-ku
Country [127] 0 0
Japan
State/province [127] 0 0
Mizunami-shi
Country [128] 0 0
Japan
State/province [128] 0 0
Niigata-shi
Country [129] 0 0
Japan
State/province [129] 0 0
Obihiro-shi
Country [130] 0 0
Japan
State/province [130] 0 0
Oita-shi
Country [131] 0 0
Japan
State/province [131] 0 0
Ota-shi
Country [132] 0 0
Japan
State/province [132] 0 0
Sagamihara-shi
Country [133] 0 0
Japan
State/province [133] 0 0
Sakai-shi
Country [134] 0 0
Japan
State/province [134] 0 0
Sakaide-shi
Country [135] 0 0
Japan
State/province [135] 0 0
Sapporo-shi
Country [136] 0 0
Japan
State/province [136] 0 0
Sendai-shi
Country [137] 0 0
Japan
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.
Trial website
https://clinicaltrials.gov/study/NCT02258542
Trial related presentations / publications
Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Brooks L, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Benralizumab for adolescent patients with severe, eosinophilic asthma: Safety and efficacy after 3 years of treatment. J Allergy Clin Immunol. 2021 Jul;148(1):266-271.e2. doi: 10.1016/j.jaci.2021.02.009. Epub 2021 Feb 17.
Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Sproule S, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019 Jan;7(1):46-59. doi: 10.1016/S2213-2600(18)30406-5. Epub 2018 Nov 8. Erratum In: Lancet Respir Med. 2019 Jan;7(1):e1. doi: 10.1016/S2213-2600(18)30518-6.
Public notes

Contacts
Principal investigator
Name 0 0
William W. Busse, M.D., Professor of Medicine
Address 0 0
Allergy, Pulmonary, and Critical Care Medicine 600 Highland Avenue; Madison, WI
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02258542