A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA

Asthma Clinical Trial

— BORA  

Official 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 β2 Agonist (BORA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02258542
• Other study ID #: D3250C00021
• Secondary ID: U1111-1162-2422
• Status: Completed
• Phase: Phase 3
• Start date: November 19, 2014
• Est. completion date: July 2, 2018

Study information

• Verified date: July 2019
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

After a minimum of 1200 patients have been enrolled in this study, subsequent patients (up to a maximum of 2200 total for the study), who complete a minimum of 16 weeks, and no more than 40 weeks, in this study, will be given the option to transition to an open-label safety extension study, Study D3250C00037 (MELTEMI).

Adolescent patients, patients from Japan and South Korea, and any patient who chooses not to enter Study D3250C00037 will remain in this study through IPD or EOT and FU.

At the time of the first interim analysis in Japanese patients, the study regimen for all patients will become unblinded to AstraZeneca for data analysis purposes. Study conduct and blinding at the site and patient level will remain unchanged.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2133
• Est. completion date: July 2, 2018
• Est. primary completion date: October 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Asthma

Intervention

Biological:
• Benralizumab
Benralizumab administered subcutaneously
• Benralizumab
Benralizumab administered subcutaneously

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Caba
Argentina	Research Site	Caba
Argentina	Research Site	Caba
Argentina	Research Site	Ciudad Autónoma de Bs. As.
Argentina	Research Site	Concepción del Uruguay
Argentina	Research Site	Córdoba
Argentina	Research Site	Corrientes
Argentina	Research Site	Florida
Argentina	Research Site	Godoy Cruz
Argentina	Research Site	La Plata
Argentina	Research Site	Mar del Plata
Argentina	Research Site	Mendoza
Argentina	Research Site	Mendoza
Argentina	Research Site	Nueve de julio
Argentina	Research Site	Ranelagh
Argentina	Research Site	Rosario
Argentina	Research Site	San Miguel de Tucuman
Australia	Research Site	Bedford Park
Australia	Research Site	Box Hill
Australia	Research Site	Clayton
Australia	Research Site	Concord
Australia	Research Site	Frankston
Australia	Research Site	Nedlands
Australia	Research Site	New Lambton Heights
Australia	Research Site	Parkville
Australia	Research Site	Prahran
Australia	Research Site	Randwick
Australia	Research Site	Woolloongabba
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Santo Andre
Brazil	Research Site	Sao Paulo
Brazil	Research Site	São Paulo
Brazil	Research Site	Sorocaba
Bulgaria	Research Site	Dupnitsa
Bulgaria	Research Site	Pazardzhik
Bulgaria	Research Site	Pernik
Bulgaria	Research Site	Petrich
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Samokov
Bulgaria	Research Site	Sliven
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Stara Zagora
Bulgaria	Research Site	Varna
Bulgaria	Research Site	Velingrad
Bulgaria	Research Site	Vratsa
Bulgaria	Research Site	Yambol
Canada	Research Site	Burlington	Ontario
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Quebec
Canada	Research Site	Sherwood Park	Alberta
Canada	Research Site	St Charles Borromee	Quebec
Canada	Research Site	Vancouver	British Columbia
Canada	Research Site	Vancouver	British Columbia
Chile	Research Site	Quillota
Chile	Research Site	Santiago
Chile	Research Site	Talcahuano
Chile	Research Site	Valparaiso
Chile	Research Site	Viña del Mar
Czechia	Research Site	Jindrichuv Hradec
Czechia	Research Site	Karlovy Vary
Czechia	Research Site	Ostrava
Czechia	Research Site	Plzen
Czechia	Research Site	Praha
Czechia	Research Site	Rokycany
Czechia	Research Site	Strakonice
Czechia	Research Site	Teplice
France	Research Site	Brest Cedex
France	Research Site	Dijon Cedex
France	Research Site	Le Kremlin Bicêtre
France	Research Site	Le Mans Cedex
France	Research Site	Lyon Cedex 4
France	Research Site	Marseille
France	Research Site	Montpellier
France	Research Site	Paris
France	Research Site	Pau Cedex
France	Research Site	Pringy Cedex
France	Research Site	Saint Pierre
France	Research Site	Strasbourg Cedex
France	Research Site	Toulouse CEDEX 09
Germany	Research Site	Aschaffenburg
Germany	Research Site	Bamberg
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Bonn
Germany	Research Site	Frankfurt
Germany	Research Site	Frankfurt am Main
Germany	Research Site	Frankfurt/Main
Germany	Research Site	Geesthacht
Germany	Research Site	Grosshansdorf
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Hannover
Germany	Research Site	Hannover
Germany	Research Site	Herford
Germany	Research Site	Leipzig
Germany	Research Site	Leipzig
Germany	Research Site	Leipzig
Germany	Research Site	Mainz Am Rhein
Germany	Research Site	München
Germany	Research Site	München
Germany	Research Site	Neu-Isenburg
Germany	Research Site	Rostock
Germany	Research Site	Rüdersdorf
Germany	Research Site	Witten
Japan	Research Site	Asahi-shi
Japan	Research Site	Chiyoda-ku
Japan	Research Site	Chuo-ku
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Hiroshima-shi
Japan	Research Site	Itabashi-ku
Japan	Research Site	Itabashi-ku
Japan	Research Site	Kagoshima-shi
Japan	Research Site	Kishiwada-shi
Japan	Research Site	Kobe-shi
Japan	Research Site	Kokubunji-shi
Japan	Research Site	Matsue-shi
Japan	Research Site	Minato-ku
Japan	Research Site	Mizunami-shi
Japan	Research Site	Niigata-shi
Japan	Research Site	Obihiro-shi
Japan	Research Site	Oita-shi
Japan	Research Site	Ota-shi
Japan	Research Site	Sagamihara-shi
Japan	Research Site	Sakai-shi
Japan	Research Site	Sakaide-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Sendai-shi
Japan	Research Site	Setagaya-ku
Japan	Research Site	Shibuya-ku
Japan	Research Site	Shinagawa-ku
Japan	Research Site	Sumida-ku
Japan	Research Site	Takamatsu-shi
Japan	Research Site	Toshima-ku
Japan	Research Site	Tsukubo-gun
Japan	Research Site	Yokohama-shi
Japan	Research Site	Yokohama-shi
Japan	Research Site	Yokohama-shi
Korea, Republic of	Research Site	Anyang-si
Korea, Republic of	Research Site	Bucheon-si
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Cheongju-si
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Jeju-si
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon-si
Peru	Research Site	Cusco
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Philippines	Research Site	Iloilo City
Philippines	Research Site	Lipa City
Philippines	Research Site	Quezon City
Poland	Research Site	Aleksandrów Lódzki
Poland	Research Site	Bialystok
Poland	Research Site	Bialystok
Poland	Research Site	Bialystok
Poland	Research Site	Bialystok
Poland	Research Site	Bielsko Biala
Poland	Research Site	Bydgoszcz
Poland	Research Site	Bystra Slaska
Poland	Research Site	Dobre Miasto
Poland	Research Site	Gdansk
Poland	Research Site	Gdansk
Poland	Research Site	Gizycko
Poland	Research Site	Gorzów Wlkp
Poland	Research Site	Grodzisk Mazowiecki
Poland	Research Site	Karczew
Poland	Research Site	Katowice
Poland	Research Site	Koscian
Poland	Research Site	Koszalin
Poland	Research Site	Kraków
Poland	Research Site	Kraków
Poland	Research Site	Kraków
Poland	Research Site	Kraków
Poland	Research Site	Lódz
Poland	Research Site	Lódz
Poland	Research Site	Lódz
Poland	Research Site	Lubin
Poland	Research Site	Lublin
Poland	Research Site	Lublin
Poland	Research Site	Lublin
Poland	Research Site	Ostrów Wielkopolski
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Proszowice
Poland	Research Site	Ruda Slaska
Poland	Research Site	Rzeszów
Poland	Research Site	Rzeszów
Poland	Research Site	Skierniewice
Poland	Research Site	Sosnowiec
Poland	Research Site	Szczecin
Poland	Research Site	Tarnów
Poland	Research Site	Trzebnica
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Wielun
Poland	Research Site	Wolomin
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Poland	Research Site	Znin
Romania	Research Site	Bragadiru
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Constanta
Romania	Research Site	Deva
Romania	Research Site	Iasi
Russian Federation	Research Site	Chelyabinsk
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Ivanovo
Russian Federation	Research Site	Izhevsk
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhny Novgorod
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Pyatigorsk
Russian Federation	Research Site	Ryazan
Russian Federation	Research Site	Saint - Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saratov
Russian Federation	Research Site	Smolensk
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	St.Petersburg
Russian Federation	Research Site	StPetersburg
Russian Federation	Research Site	Tomsk
Russian Federation	Research Site	Vladikavkaz
Russian Federation	Research Site	Vladimir
Russian Federation	Research Site	Volgograd
Russian Federation	Research Site	Volgograd
Russian Federation	Research Site	Yekaterinburg
South Africa	Research Site	Cape Town
South Africa	Research Site	Durban
South Africa	Research Site	Mowbray
South Africa	Research Site	Stanger
Spain	Research Site	Barcelona
Spain	Research Site	Barcelona
Spain	Research Site	Lugo
Spain	Research Site	Madrid
Spain	Research Site	Málaga
Spain	Research Site	Oviedo
Spain	Research Site	Palma de Mallorca
Spain	Research Site	Sagunto(Valencia)
Spain	Research Site	Salamanca
Spain	Research Site	Valencia
Spain	Research Site	Valencia
Sweden	Research Site	Göteborg
Sweden	Research Site	Lund
Turkey	Research Site	Adana
Turkey	Research Site	Ankara
Turkey	Research Site	Bursa
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Turkey	Research Site	Mersin
Ukraine	Research Site	Chernivtsi
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Ivano-Frankivsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Lutsk
Ukraine	Research Site	Uzhgorod
Ukraine	Research Site	Vinnytsia
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Bradford
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Chertsey
United Kingdom	Research Site	Chester
United Kingdom	Research Site	Cottingham
United Kingdom	Research Site	Darlington
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Liverpool
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Plymouth
United Kingdom	Research Site	Portsmouth
United Kingdom	Research Site	Soham
United Kingdom	Research Site	Somerset
United Kingdom	Research Site	Stevenage
United Kingdom	Research Site	Stockton
United States	Research Site	Abingdon	Virginia
United States	Research Site	Albany	Georgia
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Alhambra	California
United States	Research Site	Andalusia	Alabama
United States	Research Site	Arlington	Texas
United States	Research Site	Bakersfield	California
United States	Research Site	Baltimore	Maryland
United States	Research Site	Bangor	Maine
United States	Research Site	Birmingham	Alabama
United States	Research Site	Boerne	Texas
United States	Research Site	Brandon	Florida
United States	Research Site	Bronx	New York
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clearwater	Florida
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Covington	Louisiana
United States	Research Site	Cutler Bay	Florida
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Dallas	Texas
United States	Research Site	Denver	Colorado
United States	Research Site	Doral	Florida
United States	Research Site	Durham	North Carolina
United States	Research Site	Falls Church	Virginia
United States	Research Site	Farmington Hills	Michigan
United States	Research Site	Farmington Hills	Michigan
United States	Research Site	Flint	Michigan
United States	Research Site	Fort Mitchell	Kentucky
United States	Research Site	Gainesville	Georgia
United States	Research Site	Glendale	Arizona
United States	Research Site	Greenfield	Wisconsin
United States	Research Site	Gurnee	Illinois
United States	Research Site	Hialeah	Florida
United States	Research Site	Hialeah	Florida
United States	Research Site	Hodges	South Carolina
United States	Research Site	Homestead	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Iowa City	Iowa
United States	Research Site	Jefferson Hills	Pennsylvania
United States	Research Site	Lawrenceville	Georgia
United States	Research Site	Louisville	Kentucky
United States	Research Site	Madison	Wisconsin
United States	Research Site	McAllen	Texas
United States	Research Site	McKinney	Texas
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Miami	Florida
United States	Research Site	Middleburg Heights	Ohio
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	New Haven	Connecticut
United States	Research Site	New York	New York
United States	Research Site	Newport Beach	California
United States	Research Site	Normal	Illinois
United States	Research Site	Northfield	New Jersey
United States	Research Site	Ocala	Florida
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orlando	Florida
United States	Research Site	Orlando	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Provo	Utah
United States	Research Site	Quincy	Massachusetts
United States	Research Site	Rapid City	South Dakota
United States	Research Site	Redondo Beach	California
United States	Research Site	Rochester	Minnesota
United States	Research Site	Roseville	California
United States	Research Site	Sacramento	California
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Saint Paul	Minnesota
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	San Jose	California
United States	Research Site	Scottsboro	Alabama
United States	Research Site	Splendora	Texas
United States	Research Site	Staten Island	New York
United States	Research Site	Stockton	California
United States	Research Site	Tampa	Florida
United States	Research Site	Traverse City	Michigan
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Union	New Jersey
United States	Research Site	Walnut Creek	California
United States	Research Site	Warwick	Rhode Island
United States	Research Site	Westminster	California
United States	Research Site	Wheat Ridge	Colorado
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winston-Salem	North Carolina
United States	Research Site	Winter Park	Florida
United States	Research Site	Woodland	California
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Brazil,  Bulgaria,  Canada,  Chile,  Czechia,  France,  Germany,  Japan,  Korea, Republic of,  Peru,  Philippines,  Poland,  Romania,  Russian Federation,  South Africa,  Spain,  Sweden,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients	Change from baseline in hematologic lab parameter of Basophils.	Week 56
Primary	Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Change from baseline in hematologic lab parameter of Basophils.	Week 108
Primary	Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients	Change from baseline in hematologic lab parameter of Leukocytes.	Week 56
Primary	Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Change from baseline in hematologic lab parameter of Leukocytes.	Week 108
Primary	Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients	Change from baseline in hematologic lab parameter of Lymphocytes.	Week 56
Primary	Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Change from baseline in hematologic lab parameter of Lymphocytes.	Week 108
Primary	Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients	Change from baseline in hematologic lab parameter of Neutrophils.	Week 56
Primary	Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Change from baseline in hematologic lab parameter of Neutrophils.	Week 108
Primary	Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients	Change from baseline in hematologic lab parameter of Eosinophils.	Week 56
Primary	Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Change from baseline in hematologic lab parameter of Eosinophils.	Week 108
Primary	Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients	Change from baseline in chemistry tests ALT.	Week 56
Primary	Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Change from baseline in hematologic lab parameter of ALT.	Week 108
Primary	Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients	Change from baseline in chemistry tests AST.	Week 56
Primary	Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Change from baseline in hematologic lab parameter of AST.	Week 108
Primary	Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients	Change from baseline in chemistry test Bilirubin.	Week 56
Primary	Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)	Change from baseline in hematologic lab parameter of Bilirubin.	Week 108
Secondary	Number of Overall Patients With Asthma Exacerbations During Study Period	Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit	From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)
Secondary	Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA)	Annual asthma exacerbation rate, where an asthma exacerbation is defined by a worsening of asthma requiring the use of systemic corticosteroids for at least 3 days, and/or an in patient hospitalization, and/or an emergency department or urgent care visit	From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)
Secondary	Change From Baseline in Pre-bronchodilator FEV1 (L)	Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).	Week 56
Secondary	Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)	Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).	Week 108
Secondary	Change From Baseline in Post-bronchodilator FEV1 (L)	Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).	Week 56
Secondary	Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)	Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).	Week 108
Secondary	Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients	Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses.	Week 56
Secondary	Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA)	Asthma Control Questionnaire 6 (ACQ-6) contains 1 bronchodilator use question and 5 symptom questions. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score was the mean of the responses.	Week 108
Secondary	Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12)	Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement.	Week 56
Secondary	Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA)	Standardised Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) comprises 4 separate domains (symptoms, activity limitations, emotional function, and environmental stimuli). It contains 32 questions on a 7 point scale ranging from 7 (no impairment) to 1 (severe impairment); total score is an average of all questions. An increase in score indicates improvement.	Week 108
Secondary	Change of Blood Eosinophil Levels' Measurement in Overall Patients	Change from baseline to Week 56 in Blood eosinophils	Week 56
Secondary	Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA).	Change from baseline to Week 108 in Blood eosinophils.	Week 108
Secondary	Change From Baseline in EQ-5D-5L Visual Analog Scale	The questionnaire included a visual analog scale (VAS) score, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement.	Week 56
Secondary	Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA)	The questionnaire included a VAS, where the patient was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state; thus, an increase in VAS score indicated improvement.	Week 108
Secondary	Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI)	The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage.	Week 68
Secondary	Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)	The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Work productivity loss is calculated with sum of hours missed at work due to health problem and hours that affected due to health problem at work, divided by sum of hours missed due to health problem and hours actually worked, presented by percentage.	Week 108
Secondary	Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ)	The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage.	Week 56
Secondary	Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA)	The WPAI (+CIQ) is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. Classroom productivity loss is calculated with sum of hours missed for classes due to health problem and hours that affected due to health problem in classes, divided by sum of hours missed due to health problem and hours actually attended classes, presented by percentage.	Week 108
Secondary	Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI)	The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	Week 68
Secondary	Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)	The WPAI+CIQ is a 10-item questionnaire that assesses productivity and activity impairment over the previous week. The questionnaire includes hours missed from work/school due to asthma, degree health affected productivity while at work/school, as well as the degree to which health affected regular activities other than work or school. The questionnaire related to the previous 7 days. The WPAI+CIQ outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.	Week 108
Secondary	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	Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma	From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose)
Secondary	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)	Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma	Baseline and Week 108
Secondary	Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study	Endpoint: Pharmacokinetic (PK) parameters	Week 0 and Week 56
Secondary	Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA)	Endpoint: Pharmacokinetic (PK) parameters	Baseline and Week 108
Secondary	Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study	Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study	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	Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA)	Assessments for the presence of ADA and nAb throughout study	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

External Links

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•   BORA clinical study protocol-redacted