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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Benralizumab

About this trial

This is an interventional other trial for Asthma focused on measuring Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

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.
Female and male patients who completed the double-blind treatment period in a predecessor study on benralizumab or matching placebo.
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).
For WOCBP only: Have a negative urine pregnancy test prior to administration of Investigational Product (IP) at Visit 1.
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

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
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
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
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).
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
Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
Planned major surgical procedures during the conduct of the study
Previous participation in the present study
Concurrent enrolment in another clinical trial
AstraZeneca staff involved in the planning and/or conduct of the study
Employees of the study centre or any other individuals involved with the conduct of the study or immediate family members of such individuals
Patients with major protocol deviations in any of the predecessor studies at the discretion of the Sponsor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Benralizumab Arm A

Benralizumab Arm B

Arm Description

Benralizumab administered subcutaneously

Outcomes

Primary Outcome Measures

Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients

Change from baseline in hematologic lab parameter of Basophils.

Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Change from baseline in hematologic lab parameter of Basophils.

Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients

Change from baseline in hematologic lab parameter of Leukocytes.

Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Change from baseline in hematologic lab parameter of Leukocytes.

Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients

Change from baseline in hematologic lab parameter of Lymphocytes.

Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Change from baseline in hematologic lab parameter of Lymphocytes.

Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients

Change from baseline in hematologic lab parameter of Neutrophils.

Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Change from baseline in hematologic lab parameter of Neutrophils.

Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients

Change from baseline in hematologic lab parameter of Eosinophils.

Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Change from baseline in hematologic lab parameter of Eosinophils.

Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients

Change from baseline in chemistry tests ALT.

Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Change from baseline in hematologic lab parameter of ALT.

Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients

Change from baseline in chemistry tests AST.

Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Change from baseline in hematologic lab parameter of AST.

Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients

Change from baseline in chemistry test Bilirubin.

Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Change from baseline in hematologic lab parameter of Bilirubin.

Secondary Outcome Measures

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

Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA)

Change From Baseline in Pre-bronchodilator FEV1 (L)

Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).

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).

Change From Baseline in Post-bronchodilator FEV1 (L)

Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).

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).

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.

Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA)

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.

Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA)

Change of Blood Eosinophil Levels' Measurement in Overall Patients

Change from baseline to Week 56 in Blood eosinophils

Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA).

Change from baseline to Week 108 in Blood eosinophils.

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.

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.

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.

Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)

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.

Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA)

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.

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.

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

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

Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study

Endpoint: Pharmacokinetic (PK) parameters

Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA)

Endpoint: Pharmacokinetic (PK) parameters

Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study

Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study

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

Full Information

NCT ID

NCT02258542

First Posted

September 1, 2014

Last Updated

August 5, 2019

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT02258542

Brief 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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

November 19, 2014 (Actual)

Primary Completion Date

October 18, 2017 (Actual)

Study Completion Date

July 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases

7. Study Design

Primary Purpose

Other

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2133 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Benralizumab Arm A

Arm Type

Experimental

Arm Description

Benralizumab administered subcutaneously

Arm Title

Benralizumab Arm B

Arm Type

Experimental

Arm Description

Benralizumab administered subcutaneously

Intervention Type

Biological

Intervention Name(s)

Benralizumab

Intervention Description

Benralizumab administered subcutaneously

Intervention Type

Biological

Intervention Name(s)

Benralizumab

Intervention Description

Benralizumab administered subcutaneously

Primary Outcome Measure Information:

Title

Change From Baseline in Basophils, Full Analysis Set, Excluding MELTEMI Patients

Description

Change from baseline in hematologic lab parameter of Basophils.

Time Frame

Week 56

Title

Change From Baseline in Basophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Description

Change from baseline in hematologic lab parameter of Basophils.

Time Frame

Week 108

Title

Change From Baseline in Leukocytes, Full Analysis Set, Excluding MELTEMI Patients

Description

Change from baseline in hematologic lab parameter of Leukocytes.

Time Frame

Week 56

Title

Change From Baseline in Leukocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Description

Change from baseline in hematologic lab parameter of Leukocytes.

Time Frame

Week 108

Title

Change From Baseline in Lymphocytes, Full Analysis Set, Excluding MELTEMI Patients

Description

Change from baseline in hematologic lab parameter of Lymphocytes.

Time Frame

Week 56

Title

Change From Baseline in Lymphocytes, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Description

Change from baseline in hematologic lab parameter of Lymphocytes.

Time Frame

Week 108

Title

Change From Baseline in Neutrophils, Full Analysis Set, Excluding MELTEMI Patients

Description

Change from baseline in hematologic lab parameter of Neutrophils.

Time Frame

Week 56

Title

Change From Baseline in Neutrophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Description

Change from baseline in hematologic lab parameter of Neutrophils.

Time Frame

Week 108

Title

Change From Baseline in Eosinophils, Full Analysis Set, Excluding MELTEMI Patients

Description

Change from baseline in hematologic lab parameter of Eosinophils.

Time Frame

Week 56

Title

Change From Baseline in Eosinophils, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Description

Change from baseline in hematologic lab parameter of Eosinophils.

Time Frame

Week 108

Title

Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set, Excluding MELTEMI Patients

Description

Change from baseline in chemistry tests ALT.

Time Frame

Week 56

Title

Change From Baseline in ALT, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Description

Change from baseline in hematologic lab parameter of ALT.

Time Frame

Week 108

Title

Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set, Excluding MELTEMI Patients

Description

Change from baseline in chemistry tests AST.

Time Frame

Week 56

Title

Change From Baseline in AST, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Description

Change from baseline in hematologic lab parameter of AST.

Time Frame

Week 108

Title

Change From Baseline in Bilirubin, Full Analysis Set, Excluding MELTEMI Patients

Description

Change from baseline in chemistry test Bilirubin.

Time Frame

Week 56

Title

Change From Baseline in Bilirubin, Full Analysis Set, Adolescents Only (SIROCCO/CALIMA)

Description

Change from baseline in hematologic lab parameter of Bilirubin.

Time Frame

Week 108

Secondary Outcome Measure Information:

Title

Number of Overall Patients With Asthma Exacerbations During Study Period

Description

Time Frame

From week 0 to week 56 in study treatment period and through the follow up period (16 weeks from day of last dose)

Title

Number of Overall Patients With Asthma Exacerbations During Study Period, Adolescents Only (SIROCCO/CALIMA)

Description

Time Frame

From week 0 to week 108 in study treatment period and through the follow up period (16 weeks from day of last dose)

Title

Change From Baseline in Pre-bronchodilator FEV1 (L)

Description

Change from baseline to Week 56 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).

Time Frame

Week 56

Title

Change From Baseline in Pre-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)

Description

Change from baseline to Week 108 in Pre-bronchodilator Forced expiratory volume in 1 second (FEV1).

Time Frame

Week 108

Title

Change From Baseline in Post-bronchodilator FEV1 (L)

Description

Change from baseline to Week 56 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).

Time Frame

Week 56

Title

Change From Baseline in Post-bronchodilator FEV1 (L), Adolescents Only (SIROCCO/CALIMA)

Description

Change from baseline to Week 108 in Post-bronchodilator Forced expiratory volume in 1 second (FEV1).

Time Frame

Week 108

Title

Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients

Description

Time Frame

Week 56

Title

Change From Baseline in Asthma Control Questionnaire (ACQ) as a Measure of Asthma Control in Overall Patients, Adolescents Only (SIROCCO/CALIMA)

Description

Time Frame

Week 108

Title

Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12)

Description

Time Frame

Week 56

Title

Change From Baseline in Total Score of Asthma Related and General Health-related Quality of Life Questionnaire (AQLQ(S)+12), Adolescents Only (SIROCCO/CALIMA)

Description

Time Frame

Week 108

Title

Change of Blood Eosinophil Levels' Measurement in Overall Patients

Description

Change from baseline to Week 56 in Blood eosinophils

Time Frame

Week 56

Title

Change of Blood Eosinophil Levels' Measurement in Adolescents Patients (SIROCCO/CALIMA).

Description

Change from baseline to Week 108 in Blood eosinophils.

Time Frame

Week 108

Title

Change From Baseline in EQ-5D-5L Visual Analog Scale

Description

Time Frame

Week 56

Title

Change From Baseline in EQ-5D-5L Visual Analog Scale, Adolescents Only (SIROCCO/CALIMA)

Description

Time Frame

Week 108

Title

Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI)

Description

Time Frame

Week 68

Title

Work Productivity Loss in Adults, Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)

Description

Time Frame

Week 108

Title

Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ)

Description

Time Frame

Week 56

Title

Classroom Productivity Loss Using Classroom Impairment Questionnaire (CIQ), Adolescents Only (SIROCCO/CALIMA)

Description

Time Frame

Week 108

Title

Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI)

Description

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.

Time Frame

Week 68

Title

Activity Impairment (%), Using Work Productivity and Activity Impairment Questionnaire (WPAI), Adolescents Only (SIROCCO/CALIMA)

Description

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.

Time Frame

Week 108

Title

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

Description

Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma

Time Frame

From week 0 to week 68 in study treatment period and through the follow up period (16 weeks from day of last dose)

Title

Description

Hospitalizations, ED visits, urgent care visits and all other outpatient visits due to asthma

Time Frame

Baseline and Week 108

Title

Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study

Description

Endpoint: Pharmacokinetic (PK) parameters

Time Frame

Week 0 and Week 56

Title

Pre-dose Benralizumab Concentration in Serum During the Treatment Phase of the Safety Study, Adolescents Only (SIROCCO/CALIMA)

Description

Endpoint: Pharmacokinetic (PK) parameters

Time Frame

Baseline and Week 108

Title

Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study

Description

Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study

Time Frame

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

Title

Number of Patients With Anti-drug Antibodies (ADA) Responses During the Study, Adolescents Only (SIROCCO/CALIMA)

Description

Assessments for the presence of ADA and nAb throughout study

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria 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. Female and male patients who completed the double-blind treatment period in a predecessor study on benralizumab or matching placebo. 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). For WOCBP only: Have a negative urine pregnancy test prior to administration of Investigational Product (IP) at Visit 1. 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 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 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 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 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). 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 Receipt of immunoglobulin or blood products within 30 days prior to Visit 1 Planned major surgical procedures during the conduct of the study Previous participation in the present study Concurrent enrolment in another clinical trial AstraZeneca staff involved in the planning and/or conduct of the study Employees of the study centre or any other individuals involved with the conduct of the study or immediate family members of such individuals Patients with major protocol deviations in any of the predecessor studies at the discretion of the Sponsor

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William W. Busse, M.D., Professor of Medicine

Organizational Affiliation

Allergy, Pulmonary, and Critical Care Medicine 600 Highland Avenue; Madison, WI

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Andalusia

State/Province

Alabama

ZIP/Postal Code

36420

Country

United States

Facility Name

Research Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Research Site

City

Scottsboro

State/Province

Alabama

ZIP/Postal Code

35768

Country

United States

Facility Name

Research Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85012

Country

United States

Facility Name

Research Site

City

Alhambra

State/Province

California

ZIP/Postal Code

91801

Country

United States

Facility Name

Research Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Research Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Research Site

City

Redondo Beach

State/Province

California

ZIP/Postal Code

90277

Country

United States

Facility Name

Research Site

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

Research Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95825

Country

United States

Facility Name

Research Site

City

San Jose

State/Province

California

ZIP/Postal Code

95117

Country

United States

Facility Name

Research Site

City

Stockton

State/Province

California

ZIP/Postal Code

95204

Country

United States

Facility Name

Research Site

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Research Site

City

Westminster

State/Province

California

ZIP/Postal Code

92683

Country

United States

Facility Name

Research Site

City

Woodland

State/Province

California

ZIP/Postal Code

95695

Country

United States

Facility Name

Research Site

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Research Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Facility Name

Research Site

City

Wheat Ridge

State/Province

Colorado

ZIP/Postal Code

80033

Country

United States

Facility Name

Research Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

Research Site

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Research Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Research Site

City

Cutler Bay

State/Province

Florida

ZIP/Postal Code

33189

Country

United States

Facility Name

Research Site

City

Doral

State/Province

Florida

ZIP/Postal Code

33172

Country

United States

Facility Name

Research Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Research Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33013

Country

United States

Facility Name

Research Site

City

Homestead

State/Province

Florida

ZIP/Postal Code

33030

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33015

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Research Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471-4463

Country

United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32819

Country

United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32825

Country

United States

Facility Name

Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

Country

United States

Facility Name

Research Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Research Site

City

Albany

State/Province

Georgia

ZIP/Postal Code

31707

Country

United States

Facility Name

Research Site

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

Research Site

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Research Site

City

Gurnee

State/Province

Illinois

ZIP/Postal Code

60031

Country

United States

Facility Name

Research Site

City

Normal

State/Province

Illinois

ZIP/Postal Code

61761

Country

United States

Facility Name

Research Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Research Site

City

Fort Mitchell

State/Province

Kentucky

ZIP/Postal Code

41017

Country

United States

Facility Name

Research Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40215

Country

United States

Facility Name

Research Site

City

Covington

State/Province

Louisiana

ZIP/Postal Code

70433

Country

United States

Facility Name

Research Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21236

Country

United States

Facility Name

Research Site

City

Quincy

State/Province

Massachusetts

ZIP/Postal Code

02169

Country

United States

Facility Name

Research Site

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48334

Country

United States

Facility Name

Research Site

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48336

Country

United States

Facility Name

Research Site

City

Flint

State/Province

Michigan

ZIP/Postal Code

48504

Country

United States

Facility Name

Research Site

City

Traverse City

State/Province

Michigan

ZIP/Postal Code

49684

Country

United States

Facility Name

Research Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Research Site

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55130

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63143

Country

United States

Facility Name

Research Site

City

Northfield

State/Province

New Jersey

ZIP/Postal Code

08225

Country

United States

Facility Name

Research Site

City

Union

State/Province

New Jersey

ZIP/Postal Code

07083

Country

United States

Facility Name

Research Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131

Country

United States

Facility Name

Research Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Research Site

City

Staten Island

State/Province

New York

ZIP/Postal Code

10305

Country

United States

Facility Name

Research Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

Research Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Research Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27104

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

Country

United States

Facility Name

Research Site

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73131

Country

United States

Facility Name

Research Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Research Site

City

Jefferson Hills

State/Province

Pennsylvania

ZIP/Postal Code

15025

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

Research Site

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

Facility Name

Research Site

City

Hodges

State/Province

South Carolina

ZIP/Postal Code

29653

Country

United States

Facility Name

Research Site

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57702

Country

United States

Facility Name

Research Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76018

Country

United States

Facility Name

Research Site

City

Boerne

State/Province

Texas

ZIP/Postal Code

78006

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75225

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77081

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77083

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77099

Country

United States

Facility Name

Research Site

City

McAllen

State/Province

Texas

ZIP/Postal Code

78504

Country

United States

Facility Name

Research Site

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Research Site

City

Splendora

State/Province

Texas

ZIP/Postal Code

77372

Country

United States

Facility Name

Research Site

City

Provo

State/Province

Utah

ZIP/Postal Code

84604

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Facility Name

Research Site

City

Abingdon

State/Province

Virginia

ZIP/Postal Code

24210

Country

United States

Facility Name

Research Site

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22044

Country

United States

Facility Name

Research Site

City

Greenfield

State/Province

Wisconsin

ZIP/Postal Code

53228

Country

United States

Facility Name

Research Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

Research Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Research Site

City

Buenos Aires

ZIP/Postal Code

1121

Country

Argentina

Facility Name

Research Site

City

Buenos Aires

ZIP/Postal Code

C1414AIF

Country

Argentina

Facility Name

Research Site

City

Caba

ZIP/Postal Code

C1056ABJ

Country

Argentina

Facility Name

Research Site

City

Caba

ZIP/Postal Code

C1425BEN

Country

Argentina

Facility Name

Research Site

City

Caba

ZIP/Postal Code

C1431FWO

Country

Argentina

Facility Name

Research Site

City

Ciudad Autónoma de Bs. As.

ZIP/Postal Code

1426

Country

Argentina

Facility Name

Research Site

City

Concepción del Uruguay

ZIP/Postal Code

3260

Country

Argentina

Facility Name

Research Site

City

Corrientes

ZIP/Postal Code

3400

Country

Argentina

Facility Name

Research Site

City

Córdoba

ZIP/Postal Code

X5003DCE

Country

Argentina

Facility Name

Research Site

City

Florida

ZIP/Postal Code

1138

Country

Argentina

Facility Name

Research Site

City

Godoy Cruz

Country

Argentina

Facility Name

Research Site

City

La Plata

ZIP/Postal Code

B1902COS

Country

Argentina

Facility Name

Research Site

City

Mar del Plata

ZIP/Postal Code

B7600GNY

Country

Argentina

Facility Name

Research Site

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Facility Name

Research Site

City

Mendoza

ZIP/Postal Code

M5500GIP

Country

Argentina

Facility Name

Research Site

City

Nueve de julio

ZIP/Postal Code

B6500EZL

Country

Argentina

Facility Name

Research Site

City

Ranelagh

ZIP/Postal Code

1886

Country

Argentina

Facility Name

Research Site

City

Rosario

ZIP/Postal Code

S2000DEJ

Country

Argentina

Facility Name

Research Site

City

San Miguel de Tucuman

ZIP/Postal Code

4000

Country

Argentina

Facility Name

Research Site

City

Bedford Park

ZIP/Postal Code

5042

Country

Australia

Facility Name

Research Site

City

Box Hill

ZIP/Postal Code

3128

Country

Australia

Facility Name

Research Site

City

Clayton

ZIP/Postal Code

3168

Country

Australia

Facility Name

Research Site

City

Concord

ZIP/Postal Code

2139

Country

Australia

Facility Name

Research Site

City

Frankston

ZIP/Postal Code

3199

Country

Australia

Facility Name

Research Site

City

Nedlands

ZIP/Postal Code

6009

Country

Australia

Facility Name

Research Site

City

New Lambton Heights

ZIP/Postal Code

2305

Country

Australia

Facility Name

Research Site

City

Parkville

ZIP/Postal Code

3050

Country

Australia

Facility Name

Research Site

City

Prahran

ZIP/Postal Code

3004

Country

Australia

Facility Name

Research Site

City

Randwick

ZIP/Postal Code

2031

Country

Australia

Facility Name

Research Site

City

Woolloongabba

ZIP/Postal Code

4102

Country

Australia

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90035074

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

91350-200

Country

Brazil

Facility Name

Research Site

City

Santo Andre

ZIP/Postal Code

09080-110

Country

Brazil

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

Research Site

City

Sorocaba

ZIP/Postal Code

18040-425

Country

Brazil

Facility Name

Research Site

City

São Paulo

ZIP/Postal Code

04323-062

Country

Brazil

Facility Name

Research Site

City

Dupnitsa

ZIP/Postal Code

2600

Country

Bulgaria

Facility Name

Research Site

City

Pazardzhik

ZIP/Postal Code

4400

Country

Bulgaria

Facility Name

Research Site

City

Pernik

ZIP/Postal Code

2300

Country

Bulgaria

Facility Name

Research Site

City

Petrich

ZIP/Postal Code

2850

Country

Bulgaria

Facility Name

Research Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Research Site

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Research Site

City

Samokov

ZIP/Postal Code

2000

Country

Bulgaria

Facility Name

Research Site

City

Sliven

ZIP/Postal Code

8800

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1002

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1152

Country

Bulgaria

Facility Name

Research Site

City

Stara Zagora

ZIP/Postal Code

6003

Country

Bulgaria

Facility Name

Research Site

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Research Site

City

Velingrad

ZIP/Postal Code

4600

Country

Bulgaria

Facility Name

Research Site

City

Vratsa

ZIP/Postal Code

3000

Country

Bulgaria

Facility Name

Research Site

City

Yambol

ZIP/Postal Code

8600

Country

Bulgaria

Facility Name

Research Site

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

Research Site

City

Sherwood Park

State/Province

Alberta

ZIP/Postal Code

T8L 0N2

Country

Canada

Facility Name

Research Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Research Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 1Y6

Country

Canada

Facility Name

Research Site

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7N 3V2

Country

Canada

Facility Name

Research Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 4A6

Country

Canada

Facility Name

Research Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1G 6C6

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1T8

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

Research Site

City

St Charles Borromee

State/Province

Quebec

ZIP/Postal Code

J6E 2B4

Country

Canada

Facility Name

Research Site

City

Quebec

ZIP/Postal Code

G1G 3Y8

Country

Canada

Facility Name

Research Site

City

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Facility Name

Research Site

City

Quillota

ZIP/Postal Code

2260000

Country

Chile

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

8207257

Country

Chile

Facility Name

Research Site

City

Talcahuano

ZIP/Postal Code

4270918

Country

Chile

Facility Name

Research Site

City

Valparaiso

ZIP/Postal Code

2341131

Country

Chile

Facility Name

Research Site

City

Viña del Mar

ZIP/Postal Code

2520594

Country

Chile

Facility Name

Research Site

City

Jindrichuv Hradec

ZIP/Postal Code

377 01

Country

Czechia

Facility Name

Research Site

City

Karlovy Vary

ZIP/Postal Code

360 17

Country

Czechia

Facility Name

Research Site

City

Ostrava

ZIP/Postal Code

728 80

Country

Czechia

Facility Name

Research Site

City

Plzen

ZIP/Postal Code

30460

Country

Czechia

Facility Name

Research Site

City

Praha

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Research Site

City

Rokycany

ZIP/Postal Code

337 22

Country

Czechia

Facility Name

Research Site

City

Strakonice

ZIP/Postal Code

38601

Country

Czechia

Facility Name

Research Site

City

Teplice

ZIP/Postal Code

415 01

Country

Czechia

Facility Name

Research Site

City

Brest Cedex

ZIP/Postal Code

29609

Country

France

Facility Name

Research Site

City

Dijon Cedex

ZIP/Postal Code

21079

Country

France

Facility Name

Research Site

City

Le Kremlin Bicêtre

ZIP/Postal Code

94275

Country

France

Facility Name

Research Site

City

Le Mans Cedex

ZIP/Postal Code

72037

Country

France

Facility Name

Research Site

City

Lyon Cedex 4

ZIP/Postal Code

69317

Country

France

Facility Name

Research Site

City

Marseille

ZIP/Postal Code

13015

Country

France

Facility Name

Research Site

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Research Site

City

Paris

ZIP/Postal Code

75018

Country

France

Facility Name

Research Site

City

Pau Cedex

ZIP/Postal Code

64046

Country

France

Facility Name

Research Site

City

Pringy Cedex

ZIP/Postal Code

74374

Country

France

Facility Name

Research Site

City

Saint Pierre

ZIP/Postal Code

97448

Country

France

Facility Name

Research Site

City

Strasbourg Cedex

ZIP/Postal Code

67091

Country

France

Facility Name

Research Site

City

Toulouse CEDEX 09

ZIP/Postal Code

31059

Country

France

Facility Name

Research Site

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Research Site

City

Bamberg

ZIP/Postal Code

96049

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10367

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Research Site

City

Bonn

ZIP/Postal Code

53123

Country

Germany

Facility Name

Research Site

City

Frankfurt am Main

ZIP/Postal Code

60596

Country

Germany

Facility Name

Research Site

City

Frankfurt/Main

ZIP/Postal Code

60389

Country

Germany

Facility Name

Research Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Research Site

City

Geesthacht

ZIP/Postal Code

21502

Country

Germany

Facility Name

Research Site

City

Grosshansdorf

ZIP/Postal Code

22927

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

22299

Country

Germany

Facility Name

Research Site

City

Hannover

ZIP/Postal Code

30167

Country

Germany

Facility Name

Research Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Research Site

City

Hannover

ZIP/Postal Code

D-30173

Country

Germany

Facility Name

Research Site

City

Herford

ZIP/Postal Code

32049

Country

Germany

Facility Name

Research Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Research Site

City

Leipzig

ZIP/Postal Code

04207

Country

Germany

Facility Name

Research Site

City

Leipzig

ZIP/Postal Code

04275

Country

Germany

Facility Name

Research Site

City

Mainz Am Rhein

ZIP/Postal Code

55131

Country

Germany

Facility Name

Research Site

City

München

ZIP/Postal Code

80539

Country

Germany

Facility Name

Research Site

City

München

ZIP/Postal Code

80639

Country

Germany

Facility Name

Research Site

City

Neu-Isenburg

ZIP/Postal Code

63263

Country

Germany

Facility Name

Research Site

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Research Site

City

Rüdersdorf

ZIP/Postal Code

15562

Country

Germany

Facility Name

Research Site

City

Witten

ZIP/Postal Code

58452

Country

Germany

Facility Name

Research Site

City

Asahi-shi

ZIP/Postal Code

289-2511

Country

Japan

Facility Name

Research Site

City

Chiyoda-ku

ZIP/Postal Code

102-0083

Country

Japan

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

103-0022

Country

Japan

Facility Name

Research Site

City

Fukuoka-shi

ZIP/Postal Code

811-1394

Country

Japan

Facility Name

Research Site

City

Hiroshima-shi

ZIP/Postal Code

732-0052

Country

Japan

Facility Name

Research Site

City

Itabashi-ku

ZIP/Postal Code

173-8610

Country

Japan

Facility Name

Research Site

City

Itabashi-ku

ZIP/Postal Code

174-0065

Country

Japan

Facility Name

Research Site

City

Kagoshima-shi

ZIP/Postal Code

890-0064

Country

Japan

Facility Name

Research Site

City

Kishiwada-shi

ZIP/Postal Code

596-8501

Country

Japan

Facility Name

Research Site

City

Kobe-shi

ZIP/Postal Code

653-0013

Country

Japan

Facility Name

Research Site

City

Kokubunji-shi

ZIP/Postal Code

185-0014

Country

Japan

Facility Name

Research Site

City

Matsue-shi

ZIP/Postal Code

690-8556

Country

Japan

Facility Name

Research Site

City

Minato-ku

ZIP/Postal Code

105-0003

Country

Japan

Facility Name

Research Site

City

Mizunami-shi

ZIP/Postal Code

509-6134

Country

Japan

Facility Name

Research Site

City

Niigata-shi

ZIP/Postal Code

950-2085

Country

Japan

Facility Name

Research Site

City

Obihiro-shi

ZIP/Postal Code

080-0013

Country

Japan

Facility Name

Research Site

City

Oita-shi

ZIP/Postal Code

870-0021

Country

Japan

Facility Name

Research Site

City

Ota-shi

ZIP/Postal Code

373-0807

Country

Japan

Facility Name

Research Site

City

Sagamihara-shi

ZIP/Postal Code

252-0315

Country

Japan

Facility Name

Research Site

City

Sakai-shi

ZIP/Postal Code

591-8037

Country

Japan

Facility Name

Research Site

City

Sakaide-shi

ZIP/Postal Code

762-8550

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

060-0033

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

064-0807

Country

Japan

Facility Name

Research Site

City

Sendai-shi

ZIP/Postal Code

983-8520

Country

Japan

Facility Name

Research Site

City

Setagaya-ku

ZIP/Postal Code

158-0097

Country

Japan

Facility Name

Research Site

City

Shibuya-ku

ZIP/Postal Code

150-0013

Country

Japan

Facility Name

Research Site

City

Shinagawa-ku

ZIP/Postal Code

142-8666

Country

Japan

Facility Name

Research Site

City

Sumida-ku

ZIP/Postal Code

130-8587

Country

Japan

Facility Name

Research Site

City

Takamatsu-shi

ZIP/Postal Code

761-7073

Country

Japan

Facility Name

Research Site

City

Toshima-ku

ZIP/Postal Code

170-0003

Country

Japan

Facility Name

Research Site

City

Tsukubo-gun

ZIP/Postal Code

701-0304

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

231-8682

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

234-0054

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

236-0024

Country

Japan

Facility Name

Research Site

City

Anyang-si

ZIP/Postal Code

14068

Country

Korea, Republic of

Facility Name

Research Site

City

Bucheon-si

ZIP/Postal Code

14584

Country

Korea, Republic of

Facility Name

Research Site

City

Busan

ZIP/Postal Code

49201

Country

Korea, Republic of

Facility Name

Research Site

City

Busan

ZIP/Postal Code

602-702

Country

Korea, Republic of

Facility Name

Research Site

City

Cheongju-si

ZIP/Postal Code

362-804

Country

Korea, Republic of

Facility Name

Research Site

City

Gwangju

ZIP/Postal Code

61469

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

21431

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

405-760

Country

Korea, Republic of

Facility Name

Research Site

City

Jeju-si

ZIP/Postal Code

690-767

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03312

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

05030

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

07985

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

150-713

Country

Korea, Republic of

Facility Name

Research Site

City

Suwon-si

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Research Site

City

Cusco

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

15102

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

L41

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

Lima 18

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 1

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 21

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 27

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 33

Country

Peru

Facility Name

Research Site

City

Iloilo City

ZIP/Postal Code

5000

Country

Philippines

Facility Name

Research Site

City

Lipa City

ZIP/Postal Code

4217

Country

Philippines

Facility Name

Research Site

City

Quezon City

ZIP/Postal Code

1101

Country

Philippines

Facility Name

Research Site

City

Aleksandrów Łódzki

ZIP/Postal Code

95-070

Country

Poland

Facility Name

Research Site

City

Białystok

ZIP/Postal Code

15-044

Country

Poland

Facility Name

Research Site

City

Białystok

ZIP/Postal Code

15-276

Country

Poland

Facility Name

Research Site

City

Białystok

ZIP/Postal Code

15-430

Country

Poland

Facility Name

Research Site

City

Białystok

ZIP/Postal Code

15-879

Country

Poland

Facility Name

Research Site

City

Bielsko Biala

ZIP/Postal Code

43-316

Country

Poland

Facility Name

Research Site

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Research Site

City

Bystra Śląska

ZIP/Postal Code

43-360

Country

Poland

Facility Name

Research Site

City

Dobre Miasto

ZIP/Postal Code

11-040

Country

Poland

Facility Name

Research Site

City

Gdańsk

ZIP/Postal Code

80-433

Country

Poland

Facility Name

Research Site

City

Gdańsk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Research Site

City

Giżycko

ZIP/Postal Code

11-500

Country

Poland

Facility Name

Research Site

City

Gorzów Wlkp

ZIP/Postal Code

66-400

Country

Poland

Facility Name

Research Site

City

Grodzisk Mazowiecki

ZIP/Postal Code

05-825

Country

Poland

Facility Name

Research Site

City

Karczew

ZIP/Postal Code

05-480

Country

Poland

Facility Name

Research Site

City

Katowice

ZIP/Postal Code

40-081

Country

Poland

Facility Name

Research Site

City

Koszalin

ZIP/Postal Code

75-679

Country

Poland

Facility Name

Research Site

City

Kościan

ZIP/Postal Code

64-000

Country

Poland

Facility Name

Research Site

City

Kraków

ZIP/Postal Code

31-011

Country

Poland

Facility Name

Research Site

City

Kraków

ZIP/Postal Code

31-033

Country

Poland

Facility Name

Research Site

City

Kraków

ZIP/Postal Code

31-159

Country

Poland

Facility Name

Research Site

City

Kraków

ZIP/Postal Code

31-455

Country

Poland

Facility Name

Research Site

City

Lubin

ZIP/Postal Code

59-300

Country

Poland

Facility Name

Research Site

City

Lublin

ZIP/Postal Code

20-089

Country

Poland

Facility Name

Research Site

City

Lublin

ZIP/Postal Code

20-552

Country

Poland

Facility Name

Research Site

City

Lublin

ZIP/Postal Code

20-718

Country

Poland

Facility Name

Research Site

City

Ostrów Wielkopolski

ZIP/Postal Code

63-400

Country

Poland

Facility Name

Research Site

City

Poznań

ZIP/Postal Code

60-214

Country

Poland

Facility Name

Research Site

City

Poznań

ZIP/Postal Code

60-685

Country

Poland

Facility Name

Research Site

City

Poznań

ZIP/Postal Code

60-693

Country

Poland

Facility Name

Research Site

City

Poznań

ZIP/Postal Code

60-823

Country

Poland

Facility Name

Research Site

City

Proszowice

ZIP/Postal Code

32-100

Country

Poland

Facility Name

Research Site

City

Ruda Slaska

ZIP/Postal Code

41-709

Country

Poland

Facility Name

Research Site

City

Rzeszów

ZIP/Postal Code

35-205

Country

Poland

Facility Name

Research Site

City

Rzeszów

ZIP/Postal Code

35-612

Country

Poland

Facility Name

Research Site

City

Skierniewice

ZIP/Postal Code

96-100

Country

Poland

Facility Name

Research Site

City

Sosnowiec

ZIP/Postal Code

41-200

Country

Poland

Facility Name

Research Site

City

Szczecin

ZIP/Postal Code

70-111

Country

Poland

Facility Name

Research Site

City

Tarnów

ZIP/Postal Code

33-100

Country

Poland

Facility Name

Research Site

City

Trzebnica

ZIP/Postal Code

55-100

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

01-138

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

01-868

Country

Poland

Facility Name

Research Site

City

Wieluń

ZIP/Postal Code

98-300

Country

Poland

Facility Name

Research Site

City

Wołomin

ZIP/Postal Code

05-200

Country

Poland

Facility Name

Research Site

City

Wroclaw

ZIP/Postal Code

53-201

Country

Poland

Facility Name

Research Site

City

Wrocław

ZIP/Postal Code

50-220

Country

Poland

Facility Name

Research Site

City

Wrocław

ZIP/Postal Code

51-162

Country

Poland

Facility Name

Research Site

City

Wrocław

ZIP/Postal Code

53-301

Country

Poland

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

90-141

Country

Poland

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

90-242

Country

Poland

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

91-103

Country

Poland

Facility Name

Research Site

City

Żnin

ZIP/Postal Code

88-400

Country

Poland

Facility Name

Research Site

City

Bragadiru

ZIP/Postal Code

077025

Country

Romania

Facility Name

Research Site

City

Bucharest

ZIP/Postal Code

030303

Country

Romania

Facility Name

Research Site

City

Bucharest

ZIP/Postal Code

71593

Country

Romania

Facility Name

Research Site

City

Constanta

ZIP/Postal Code

900002

Country

Romania

Facility Name

Research Site

City

Deva

ZIP/Postal Code

330061

Country

Romania

Facility Name

Research Site

City

Iasi

ZIP/Postal Code

700115

Country

Romania

Facility Name

Research Site

City

Chelyabinsk

ZIP/Postal Code

454106

Country

Russian Federation

Facility Name

Research Site

City

Ekaterinburg

ZIP/Postal Code

620039

Country

Russian Federation

Facility Name

Research Site

City

Ekaterinburg

ZIP/Postal Code

620109

Country

Russian Federation

Facility Name

Research Site

City

Ivanovo

ZIP/Postal Code

153005

Country

Russian Federation

Facility Name

Research Site

City

Izhevsk

ZIP/Postal Code

426063

Country

Russian Federation

Facility Name

Research Site

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

109240

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115682

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

121309

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

123995

Country

Russian Federation

Facility Name

Research Site

City

Nizhny Novgorod

ZIP/Postal Code

603126

Country

Russian Federation

Facility Name

Research Site

City

Novosibirsk

ZIP/Postal Code

630008

Country

Russian Federation

Facility Name

Research Site

City

Novosibirsk

ZIP/Postal Code

630084

Country

Russian Federation

Facility Name

Research Site

City

Pyatigorsk

ZIP/Postal Code

357500

Country

Russian Federation

Facility Name

Research Site

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

Research Site

City

Saint - Petersburg

ZIP/Postal Code

196657

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

196084

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

196084

Country

Russian Federation

Facility Name

Research Site

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Research Site

City

Smolensk

ZIP/Postal Code

214019

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

ZIP/Postal Code

194356

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

ZIP/Postal Code

196247

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Research Site

City

St.Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Research Site

City

StPetersburg

ZIP/Postal Code

193312

Country

Russian Federation

Facility Name

Research Site

City

Tomsk

ZIP/Postal Code

634063

Country

Russian Federation

Facility Name

Research Site

City

Vladikavkaz

ZIP/Postal Code

362007

Country

Russian Federation

Facility Name

Research Site

City

Vladimir

ZIP/Postal Code

600023

Country

Russian Federation

Facility Name

Research Site

City

Volgograd

ZIP/Postal Code

400001

Country

Russian Federation

Facility Name

Research Site

City

Volgograd

ZIP/Postal Code

400131

Country

Russian Federation

Facility Name

Research Site

City

Yekaterinburg

ZIP/Postal Code

620149

Country

Russian Federation

Facility Name

Research Site

City

Cape Town

ZIP/Postal Code

7764

Country

South Africa

Facility Name

Research Site

City

Durban

ZIP/Postal Code

4092

Country

South Africa

Facility Name

Research Site

City

Mowbray

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Research Site

City

Stanger

ZIP/Postal Code

4450

Country

South Africa

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Research Site

City

Lugo

ZIP/Postal Code

27004

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Research Site

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Research Site

City

Oviedo

ZIP/Postal Code

33011

Country

Spain

Facility Name

Research Site

City

Palma de Mallorca

ZIP/Postal Code

07010

Country

Spain

Facility Name

Research Site

City

Sagunto(Valencia)

ZIP/Postal Code

46520

Country

Spain

Facility Name

Research Site

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46015

Country

Spain

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46017

Country

Spain

Facility Name

Research Site

City

Göteborg

Country

Sweden

Facility Name

Research Site

City

Lund

ZIP/Postal Code

22185

Country

Sweden

Facility Name

Research Site

City

Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Research Site

City

Bursa

ZIP/Postal Code

16059

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Research Site

City

İstanbul

ZIP/Postal Code

34844

Country

Turkey

Facility Name

Research Site

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Research Site

City

Mersin

ZIP/Postal Code

33343

Country

Turkey

Facility Name

Research Site

City

Chernivtsi

ZIP/Postal Code

58000

Country

Ukraine

Facility Name

Research Site

City

Dnipropetrovsk

ZIP/Postal Code

49007

Country

Ukraine

Facility Name

Research Site

City

Ivano-Frankivsk

ZIP/Postal Code

76012

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61022

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61035

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61058

Country

Ukraine

Facility Name

Research Site

City

Kharkiv

ZIP/Postal Code

61106

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

04201

Country

Ukraine

Facility Name

Research Site

City

Lutsk

ZIP/Postal Code

43000

Country

Ukraine

Facility Name

Research Site

City

Uzhgorod

ZIP/Postal Code

88000

Country

Ukraine

Facility Name

Research Site

City

Vinnytsia

ZIP/Postal Code

21029

Country

Ukraine

Facility Name

Research Site

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

Research Site

City

Bradford

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Research Site

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Research Site

City

Chertsey

ZIP/Postal Code

KT16 0PZ

Country

United Kingdom

Facility Name

Research Site

City

Chester

ZIP/Postal Code

CH2 1UL

Country

United Kingdom

Facility Name

Research Site

City

Cottingham

ZIP/Postal Code

HU16 5JQ

Country

United Kingdom

Facility Name

Research Site

City

Darlington

ZIP/Postal Code

DL3 6HX

Country

United Kingdom

Facility Name

Research Site

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Facility Name

Research Site

City

Liverpool

ZIP/Postal Code

L7 8XP

Country

United Kingdom

Facility Name

Research Site

City

Manchester

ZIP/Postal Code

M23 9LT

Country

United Kingdom

Facility Name

Research Site

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

Research Site

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

Research Site

City

Portsmouth

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

Facility Name

Research Site

City

Soham

ZIP/Postal Code

CB7 5JD

Country

United Kingdom

Facility Name

Research Site

City

Somerset

ZIP/Postal Code

BS26 2BJ

Country

United Kingdom

Facility Name

Research Site

City

Stevenage

ZIP/Postal Code

SG1 4AB

Country

United Kingdom

Facility Name

Research Site

City

Stockton

ZIP/Postal Code

TS19 8PE

Country

United Kingdom

Facility Name

Research Site

City

Hanoi

ZIP/Postal Code

100000

Country

Vietnam

Facility Name

Research Site

City

Ho Chi Minh

ZIP/Postal Code

700000

Country

Vietnam

12. IPD Sharing Statement

Citations:

PubMed Identifier

33609624

Citation

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.

Results Reference

derived

PubMed Identifier

30416083

Citation

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.

Results Reference

derived

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2560&filename=D3250C00021_Revised_CSP_3_16Dec2016_Redacted.pdf

Description

Related Info

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2560&filename=D3250C00021_SAP_Edition_3_11_Dec2017_Redacted.pdf

Description

Related Info

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2560&filename=BORA_clinical_study_protocol-redacted.pdf

Description

BORA clinical study protocol-redacted

Learn more about this trial

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

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

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial