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Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Benralizumab

Placebo

About this trial

This is an interventional treatment 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:

Written informed consent 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 aged 12 to 75 years inclusively, at the time of visit 1. For those patients, who are 17 on the day of Visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial.
History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1
Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers.
- For subjects 18 years of age and older, the ICS dose must be >500 mcg/day fluticasone propionate dry powder formulation or equivalent daily.
- For subjects ages 12-17, the ICS dose must be ≥500 mcg /day fluticasone propionate dry powder formulation or equivalent daily.

Exclusion criteria:

Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome)
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
- 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
Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Benralizumab 30 mg q.4 weeks

Benralizumab 30 mg q.8 weeks

Placebo

Arm Description

Benralizumab administered subcutaneously every 4 weeks

Benralizumab administered subcutaneously every 8 weeks

Placebo administered subcutaneously

Outcomes

Primary Outcome Measures

Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL

The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF

Secondary Outcome Measures

Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL

The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF

Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations

The annual exacerbation rate associated with an emergency room visit or a hospitalization (adjudicated)

Number of Patients With >=1 Asthma Exacerbations

Time to First Asthma Exacerbation

Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL

Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL

Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL

Asthma symptoms during night time and daytime are recorded by the patient in the asthma daily diary. Symptom score values are from 0 (No asthma symptom) to 3 (unable to sleep because of asthma, or unable to do normal activities due to asthma), and total asthma symptom score is the sum of the daytime and night time score (0 to 6). Lower score (0) is indicating better asthma symptom, while higher score (6) is indicating worse asthma symptom. Baseline is defined as the average of data collected from the evening of study day -10 to the morning of study day 1. Each time point is calculated as bi-weekly means based on daily diary data. If more than 50% of scores are missing in a 14 day period then this is considered as missing. Symptom score lower is better.

Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL

Change in Asthma Rescue Medication

Change from baseline to week 48 in number of rescue medication use (puffs/day)

Home Lung Function Assessment Based on Morning PEF

Change from baseline to week 48 in home lung function morning peak expiratory flow [PEF]

Home Lung Function Assessment Based on Evening PEF

Change from baseline to week 48 in home lung function evening peak expiratory flow [PEF]

Proportion of Night Awakening Due to Asthma

Change from baseline to Week 48 on proportion of night awakening due to asthma

Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL

ACQ-6 contains one bronchodilator question and 5 symptom questions. Questions are rated from 0 (totally controlled) to 6 (severely uncontrolled). Mean ACQ-6 score is the average of the responses. Mean scores of <=0.75 indicates well-controlled asthma, scores between 0.75 to <=1.5 indicate partly controlled asthma, and >1.5 indicates not well controlled asthma.

Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL

Pharmacokinetics of Benralizumab

Mean PK concentrations at each visit

Immunogenicity of Benralizumab

Anti-drug antibodies (ADA) responses at baseline and post baseline. Persistently positive is defined as positive at >=2 post baseline assessments (with >=16 weeks between the first and the last positive) or positive at last post baseline assessment. Transiently positive is defined as having at least one post baseline ADA positive assessment and not fulfilling the conditions of persistently positive.

Extend of Exposure

Extend of exposure is defined as duration of treatment in days

Mean Change From Baseline to Week 48 in AQLQ(S)+12

AQLQ(S)+12 overall score is defined as the average of all 32 questions in the AQLQ(S)+12 questionnaire. AQLQ(S)+12 is a 7-point scale questionnaire, ranging from 7 (no impairment) to 1 (severe impairment). Total or domain score change of >=0.5 are considered clinically meaningful.

Mean Change From Baseline to Week 48 in EQ-5D-5L VAS

EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.

Mean Work Productivity Loss Due to Asthma

WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Work productivity loss is derived by sum of percentage of missed work due to asthma and product of percentage of actual working hours times degree of asthma affecting work productivity while working. Percentage of missed work due to asthma is calculated by number of hours missed work due to asthma divided by total number of hours missed work plus number of hours actually worked. The work productivity loss is only applicable to patients who employed, which is only subset of the study population.

Mean Productivity Loss Due to Asthma in Classroom

WPAI+CIQ (Work Productivity and Activity Impairment plus Classroom Impairment Questionnaire) contains 10 questions. Classroom productivity loss is derived by sum of percentage of missed classes due to asthma and product of percentage of actual hours attending classes times degree of asthma affecting classroom productivity. Percentage of missed classes due to asthma is calculated by number of hours missed classes due to asthma divided by total number of hours missed classes plus number of hours actually attending classes. This is only applicable to patients who attending classes

Number of Participants That Utilized Health Care Resources

Patient and Clinician's Responder Assessment to Treatment

CGIC (Clinical global impression of change), and PGIC (Patient global impression of change) are overall evaluation of response to treatment, conducted separately by investigator and patient using 7-point rating scale, ranging from 1 (very much improved), to 7 (very much worse). This is additional measures collected after second Amendment, thus not all patients had data to be analyzed.

Full Information

NCT ID

NCT01928771

First Posted

August 16, 2013

Last Updated

March 23, 2017

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01928771

Brief Title

Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

Official Title

A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

September 19, 2013 (undefined)

Primary Completion Date

April 5, 2016 (Actual)

Study Completion Date

April 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.

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

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

2681 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Benralizumab 30 mg q.4 weeks

Arm Type

Experimental

Arm Description

Benralizumab administered subcutaneously every 4 weeks

Arm Title

Benralizumab 30 mg q.8 weeks

Arm Type

Experimental

Arm Description

Benralizumab administered subcutaneously every 8 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered subcutaneously

Intervention Type

Biological

Intervention Name(s)

Benralizumab

Intervention Description

Benralizumab subcutaneously on study week 0 until study week 44 inclusive.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Placebo subcutaneously on study week 0 until study week 44 inclusive.

Primary Outcome Measure Information:

Title

Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL

Description

The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Secondary Outcome Measure Information:

Title

Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL

Description

The annual exacerbation rate is based on unadjudicated annual exacerbation rate reported by the investigator in the eCRF

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations

Description

The annual exacerbation rate associated with an emergency room visit or a hospitalization (adjudicated)

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Number of Patients With >=1 Asthma Exacerbations

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Time to First Asthma Exacerbation

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL

Description

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL

Description

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Change in Asthma Rescue Medication

Description

Change from baseline to week 48 in number of rescue medication use (puffs/day)

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Home Lung Function Assessment Based on Morning PEF

Description

Change from baseline to week 48 in home lung function morning peak expiratory flow [PEF]

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Home Lung Function Assessment Based on Evening PEF

Description

Change from baseline to week 48 in home lung function evening peak expiratory flow [PEF]

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Proportion of Night Awakening Due to Asthma

Description

Change from baseline to Week 48 on proportion of night awakening due to asthma

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL

Description

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL

Description

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Pharmacokinetics of Benralizumab

Description

Mean PK concentrations at each visit

Time Frame

Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56

Title

Immunogenicity of Benralizumab

Description

Time Frame

Pre-treatment until end of follow-up

Title

Extend of Exposure

Description

Extend of exposure is defined as duration of treatment in days

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Mean Change From Baseline to Week 48 in AQLQ(S)+12

Description

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Mean Change From Baseline to Week 48 in EQ-5D-5L VAS

Description

EQ-5D-5L VAS is to rate current health status on a scale of 0-100, with 0 being the worst imaginable health state.

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Mean Work Productivity Loss Due to Asthma

Description

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Mean Productivity Loss Due to Asthma in Classroom

Description

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Number of Participants That Utilized Health Care Resources

Time Frame

Immediately following the first administration of study drug through Study Week 48.

Title

Patient and Clinician's Responder Assessment to Treatment

Description

Time Frame

Immediately following the first administration of study drug through Study Week 48

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: Written informed consent 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 aged 12 to 75 years inclusively, at the time of visit 1. For those patients, who are 17 on the day of Visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial. History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1 Documented treatment with ICS and LABA for at least 3 months prior to Visit 1 with or without oral corticosteroids and additional asthma controllers. For subjects 18 years of age and older, the ICS dose must be >500 mcg/day fluticasone propionate dry powder formulation or equivalent daily. For subjects ages 12-17, the ICS dose must be ≥500 mcg /day fluticasone propionate dry powder formulation or equivalent daily. Exclusion criteria: Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome) Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could: 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 Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eugene R. Bleecker, MD, Professor of Medicine

Organizational Affiliation

Center for Genomics and Personalized Medicine Research, Medical Center Boulevard, Winston-Salem, North Carolina 27157

Official's Role

Principal Investigator

Facility Information:

Facility Name

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Foley

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Alabama

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United States

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Huntsville

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Alabama

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Mobile

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Scottsboro

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Sheffield

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Phoenix

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Tucson

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Bakersfield

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Beverly Hills

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Costa Mesa

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Huntington Beach

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Huntington Park

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Los Angles

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Newport Beach

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Orange

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Riverside

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San Jose

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Santa Ana

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Hartford

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New Haven

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Brandon

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Clearwater

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Cutler Bay

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DeLand

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Gainesville

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Hialeah

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Hollywood

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Homestead

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Jackonsville

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Lynn Haven

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Miami

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Orlando

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Pembroke Pines

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Port Charlotte

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Sebring

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St Petersburg

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Tampa

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Vero Beach

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Winter Park

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Albany

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Gainesville

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Lawrenceville

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Gurnee

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Normal

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Iowa City

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Fort Mitchell

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Hazard

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Louisville

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Opelousas

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Gardner

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North Dartmouth

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Quincy

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Rochester

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Bellevue

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Las Vegas

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Sparks

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Marlton

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Northfield

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Union

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Albuquerque

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Bronx

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Hopewell Jct

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New York City

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New York

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New York

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Staten Island

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Shelby

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Grand Forks

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Oregon

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Toledo

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Wooster

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Oklahoma City

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Oklahoma

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Tulsa

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Erie

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Feasterville

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Philadelphia

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Phoenixville

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Pittsburgh

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Warwick

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Charleston

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Easley

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Hodges

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Mt Pleasant

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Rock Hill

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Chattanooga

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Germantown

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Allen

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Dallas

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Dickinson

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Duncanville

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Georgetown

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Houston

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McAllen

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McKinney

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Research Site

City

Pharr

State/Province

Texas

Country

United States

Facility Name

Research Site

City

Plano

State/Province

Texas

Country

United States

Facility Name

Research Site

City

Sealy

State/Province

Texas

Country

United States

Facility Name

Research Site

City

Splendora

State/Province

Texas

Country

United States

Facility Name

Research Site

City

Orem

State/Province

Utah

Country

United States

Facility Name

Research Site

City

Provo

State/Province

Utah

Country

United States

Facility Name

Research Site

City

Salt Lake City

State/Province

Utah

Country

United States

Facility Name

Research Site

City

Abingdon

State/Province

Virginia

Country

United States

Facility Name

Research Site

City

Hopewell

State/Province

Virginia

Country

United States

Facility Name

Research Site

City

Morgantown

State/Province

West Virginia

Country

United States

Facility Name

Research Site

City

Greenfield

State/Province

Wisconsin

Country

United States

Facility Name

Research Site

City

Bedford Park

Country

Australia

Facility Name

Research Site

City

Box Hill

Country

Australia

Facility Name

Research Site

City

Clayton

Country

Australia

Facility Name

Research Site

City

Concord

Country

Australia

Facility Name

Research Site

City

Frankston

Country

Australia

Facility Name

Research Site

City

Nedlands

Country

Australia

Facility Name

Research Site

City

New Lambton Heights

Country

Australia

Facility Name

Research Site

City

Parkville

Country

Australia

Facility Name

Research Site

City

Prahran

Country

Australia

Facility Name

Research Site

City

Randwick

Country

Australia

Facility Name

Research Site

City

Woolloongabba

Country

Australia

Facility Name

Research Site

City

Porto Alegre

Country

Brazil

Facility Name

Research Site

City

Rio de Janeiro

Country

Brazil

Facility Name

Research Site

City

Santo André

Country

Brazil

Facility Name

Research Site

City

Sao Paulo

Country

Brazil

Facility Name

Research Site

City

Sorocaba

Country

Brazil

Facility Name

Research Site

City

São Paulo

Country

Brazil

Facility Name

Research Site

City

Dupnitsa

Country

Bulgaria

Facility Name

Research Site

City

Pernik

Country

Bulgaria

Facility Name

Research Site

City

Pleven

Country

Bulgaria

Facility Name

Research Site

City

Ruse

Country

Bulgaria

Facility Name

Research Site

City

Samokov

Country

Bulgaria

Facility Name

Research Site

City

Sliven

Country

Bulgaria

Facility Name

Research Site

City

Sofia

Country

Bulgaria

Facility Name

Research Site

City

Stara Zagora

Country

Bulgaria

Facility Name

Research Site

City

Varna

Country

Bulgaria

Facility Name

Research Site

City

Velingrad

Country

Bulgaria

Facility Name

Research Site

City

Yambol

Country

Bulgaria

Facility Name

Research Site

City

Brno

Country

Czech Republic

Facility Name

Research Site

City

Jindrichuv Hradec

Country

Czech Republic

Facility Name

Research Site

City

Karlovy Vary

Country

Czech Republic

Facility Name

Research Site

City

Ostrava

Country

Czech Republic

Facility Name

Research Site

City

Pardubice

Country

Czech Republic

Facility Name

Research Site

City

Plzen

Country

Czech Republic

Facility Name

Research Site

City

Praha

Country

Czech Republic

Facility Name

Research Site

City

Rokycany

Country

Czech Republic

Facility Name

Research Site

City

Strakonice

Country

Czech Republic

Facility Name

Research Site

City

Teplice

Country

Czech Republic

Facility Name

Research Site

City

Brest Cedex

Country

France

Facility Name

Research Site

City

Clermont Ferrand

Country

France

Facility Name

Research Site

City

Dijon Cedex

Country

France

Facility Name

Research Site

City

Le Kremlin Bicêtre

Country

France

Facility Name

Research Site

City

Le Mans Cedex

Country

France

Facility Name

Research Site

City

Lyon Cedex 4

Country

France

Facility Name

Research Site

City

Marseille

Country

France

Facility Name

Research Site

City

Montpellier

Country

France

Facility Name

Research Site

City

Paris

Country

France

Facility Name

Research Site

City

Pau Cedex

Country

France

Facility Name

Research Site

City

Pringy Cedex

Country

France

Facility Name

Research Site

City

Saint Pierre

Country

France

Facility Name

Research Site

City

Strasbourg Cedex

Country

France

Facility Name

Research Site

City

Toulouse

Country

France

Facility Name

Research Site

City

Bari

Country

Italy

Facility Name

Research Site

City

Bologna

Country

Italy

Facility Name

Research Site

City

Catania

Country

Italy

Facility Name

Research Site

City

Cona

Country

Italy

Facility Name

Research Site

City

Firenze

Country

Italy

Facility Name

Research Site

City

Foggia

Country

Italy

Facility Name

Research Site

City

Legnago

Country

Italy

Facility Name

Research Site

City

Milano

Country

Italy

Facility Name

Research Site

City

Napoli

Country

Italy

Facility Name

Research Site

City

Palermo

Country

Italy

Facility Name

Research Site

City

Pavia

Country

Italy

Facility Name

Research Site

City

Perugia

Country

Italy

Facility Name

Research Site

City

Pisa

Country

Italy

Facility Name

Research Site

City

Roma

Country

Italy

Facility Name

Research Site

City

San Pietro Vernotico

Country

Italy

Facility Name

Research Site

City

Torino

Country

Italy

Facility Name

Research Site

City

Verona

Country

Italy

Facility Name

Research Site

City

Anyang-si

Country

Korea, Republic of

Facility Name

Research Site

City

Bucheon-si

Country

Korea, Republic of

Facility Name

Research Site

City

Busan

Country

Korea, Republic of

Facility Name

Research Site

City

Cheongju-si

Country

Korea, Republic of

Facility Name

Research Site

City

Gwangju

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

Country

Korea, Republic of

Facility Name

Research Site

City

Jeju-si

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

Country

Korea, Republic of

Facility Name

Research Site

City

Suwon-si

Country

Korea, Republic of

Facility Name

Research Site

City

Guadalajara

Country

Mexico

Facility Name

Research Site

City

Monterrey

Country

Mexico

Facility Name

Research Site

City

Morelia

Country

Mexico

Facility Name

Research Site

City

Cusco

Country

Peru

Facility Name

Research Site

City

Lima

Country

Peru

Facility Name

Research Site

City

Surco

Country

Peru

Facility Name

Research Site

City

Białystok

Country

Poland

Facility Name

Research Site

City

Dobre Miasto

Country

Poland

Facility Name

Research Site

City

Gdańsk

Country

Poland

Facility Name

Research Site

City

Giżycko

Country

Poland

Facility Name

Research Site

City

Grodzisk Mazowiecki

Country

Poland

Facility Name

Research Site

City

Kościan

Country

Poland

Facility Name

Research Site

City

Legnica

Country

Poland

Facility Name

Research Site

City

Lublin

Country

Poland

Facility Name

Research Site

City

Poznań

Country

Poland

Facility Name

Research Site

City

Proszowice

Country

Poland

Facility Name

Research Site

City

Rzeszów

Country

Poland

Facility Name

Research Site

City

Sosnowiec

Country

Poland

Facility Name

Research Site

City

Wołomin

Country

Poland

Facility Name

Research Site

City

Wrocław

Country

Poland

Facility Name

Research Site

City

Zgierz

Country

Poland

Facility Name

Research Site

City

Łódź

Country

Poland

Facility Name

Research Site

City

Chelyabinsk

Country

Russian Federation

Facility Name

Research Site

City

Ekaterinburg

Country

Russian Federation

Facility Name

Research Site

City

Ivanovo

Country

Russian Federation

Facility Name

Research Site

City

Izhevsk

Country

Russian Federation

Facility Name

Research Site

City

Kazan

Country

Russian Federation

Facility Name

Research Site

City

Moscow

Country

Russian Federation

Facility Name

Research Site

City

Nizhny Novgorod

Country

Russian Federation

Facility Name

Research Site

City

Novosibirsk

Country

Russian Federation

Facility Name

Research Site

City

Pyatigorsk

Country

Russian Federation

Facility Name

Research Site

City

Rostov-on-Don

Country

Russian Federation

Facility Name

Research Site

City

Ryazan

Country

Russian Federation

Facility Name

Research Site

City

Saint - Petersburg

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

Country

Russian Federation

Facility Name

Research Site

City

Saratov

Country

Russian Federation

Facility Name

Research Site

City

Smolensk

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

Country

Russian Federation

Facility Name

Research Site

City

StPetersburg

Country

Russian Federation

Facility Name

Research Site

City

Tomsk

Country

Russian Federation

Facility Name

Research Site

City

Vladikavkaz

Country

Russian Federation

Facility Name

Research Site

City

Vladimir

Country

Russian Federation

Facility Name

Research Site

City

Volgograd

Country

Russian Federation

Facility Name

Research Site

City

Yaroslavl

Country

Russian Federation

Facility Name

Research Site

City

Yekaterinburg

Country

Russian Federation

Facility Name

Research Site

City

Benoni

Country

South Africa

Facility Name

Research Site

City

Cape Town

Country

South Africa

Facility Name

Research Site

City

Durban

Country

South Africa

Facility Name

Research Site

City

Mowbray

Country

South Africa

Facility Name

Research Site

City

Stanger

Country

South Africa

Facility Name

Research Site

City

Barcelona

Country

Spain

Facility Name

Research Site

City

Lugo

Country

Spain

Facility Name

Research Site

City

Madrid

Country

Spain

Facility Name

Research Site

City

Málaga

Country

Spain

Facility Name

Research Site

City

Oviedo

Country

Spain

Facility Name

Research Site

City

Palma de Mallorca

Country

Spain

Facility Name

Research Site

City

Sagunto(Valencia)

Country

Spain

Facility Name

Research Site

City

Salamanca

Country

Spain

Facility Name

Research Site

City

Valencia

Country

Spain

Facility Name

Research Site

City

Adana

Country

Turkey

Facility Name

Research Site

City

Ankara

Country

Turkey

Facility Name

Research Site

City

Antalya

Country

Turkey

Facility Name

Research Site

City

Bursa

Country

Turkey

Facility Name

Research Site

City

Istanbul

Country

Turkey

Facility Name

Research Site

City

Izmir

Country

Turkey

Facility Name

Research Site

City

Kocaeli

Country

Turkey

Facility Name

Research Site

City

Mersin

Country

Turkey

Facility Name

Research Site

City

Birmingham

Country

United Kingdom

Facility Name

Research Site

City

Bradford

Country

United Kingdom

Facility Name

Research Site

City

Cambridge

Country

United Kingdom

Facility Name

Research Site

City

Chertsey

Country

United Kingdom

Facility Name

Research Site

City

Chester

Country

United Kingdom

Facility Name

Research Site

City

Chippenham

Country

United Kingdom

Facility Name

Research Site

City

Cottingham

Country

United Kingdom

Facility Name

Research Site

City

Darlington

Country

United Kingdom

Facility Name

Research Site

City

Glasgow

Country

United Kingdom

Facility Name

Research Site

City

High Heaton/Newcastle upon Tyn

Country

United Kingdom

Facility Name

Research Site

City

Leeds

Country

United Kingdom

Facility Name

Research Site

City

Liverpool

Country

United Kingdom

Facility Name

Research Site

City

London

Country

United Kingdom

Facility Name

Research Site

City

Maidstone

Country

United Kingdom

Facility Name

Research Site

City

Manchester

Country

United Kingdom

Facility Name

Research Site

City

Nottingham

Country

United Kingdom

Facility Name

Research Site

City

Plymouth

Country

United Kingdom

Facility Name

Research Site

City

Portsmouth

Country

United Kingdom

Facility Name

Research Site

City

Soham

Country

United Kingdom

Facility Name

Research Site

City

Somerset

Country

United Kingdom

Facility Name

Research Site

City

Stevenage

Country

United Kingdom

Facility Name

Research Site

City

Stockton

Country

United Kingdom

Facility Name

Research Site

City

Hanoi

Country

Vietnam

Facility Name

Research Site

City

Ho Chi Minh

Country

Vietnam

12. IPD Sharing Statement

Citations:

PubMed Identifier

35287231

Citation

Menzies-Gow A, Hoyte FL, Price DB, Cohen D, Barker P, Kreindler J, Jison M, Brooks CL, Papeleu P, Katial R. Clinical Remission in Severe Asthma: A Pooled Post Hoc Analysis of the Patient Journey with Benralizumab. Adv Ther. 2022 May;39(5):2065-2084. doi: 10.1007/s12325-022-02098-1. Epub 2022 Mar 14.

Results Reference

derived

PubMed Identifier

32334141

Citation

Lugogo NL, Kreindler JL, Martin UJ, Cook B, Hirsch I, Trudo FJ. Blood eosinophil count group shifts and kinetics in severe eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Aug;125(2):171-176. doi: 10.1016/j.anai.2020.04.011. Epub 2020 Apr 22.

Results Reference

derived

PubMed Identifier

31836949

Citation

Jackson DJ, Humbert M, Hirsch I, Newbold P, Garcia Gil E. Ability of Serum IgE Concentration to Predict Exacerbation Risk and Benralizumab Efficacy for Patients with Severe Eosinophilic Asthma. Adv Ther. 2020 Feb;37(2):718-729. doi: 10.1007/s12325-019-01191-2. Epub 2019 Dec 14.

Results Reference

derived

PubMed Identifier

31626906

Citation

Chipps BE, Hirsch I, Trudo F, Alacqua M, Zangrilli JG. Benralizumab efficacy for patients with fixed airflow obstruction and severe, uncontrolled eosinophilic asthma. Ann Allergy Asthma Immunol. 2020 Jan;124(1):79-86. doi: 10.1016/j.anai.2019.10.006. Epub 2019 Oct 15.

Results Reference

derived

PubMed Identifier

30802500

Citation

Chupp G, Lugogo NL, Kline JN, Ferguson GT, Hirsch I, Goldman M, Zangrilli JG, Trudo F. Rapid onset of effect of benralizumab on morning peak expiratory flow in severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2019 May;122(5):478-485. doi: 10.1016/j.anai.2019.02.016. Epub 2019 Feb 23.

Results Reference

derived

PubMed Identifier

30139780

Citation

Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, Goldman M, Newbold P, Zangrilli JG. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018 Oct 18;52(4):1800936. doi: 10.1183/13993003.00936-2018. Print 2018 Oct.

Results Reference

derived

PubMed Identifier

30077185

Citation

DuBuske L, Newbold P, Wu Y, Trudo F. Seasonal variability of exacerbations of severe, uncontrolled eosinophilic asthma and clinical benefits of benralizumab. Allergy Asthma Proc. 2018 Sep 4;39(5):345-349. doi: 10.2500/aap.2018.39.4162. Epub 2018 Aug 4.

Results Reference

derived

PubMed Identifier

29409951

Citation

Chipps BE, Newbold P, Hirsch I, Trudo F, Goldman M. Benralizumab efficacy by atopy status and serum immunoglobulin E for patients with severe, uncontrolled asthma. Ann Allergy Asthma Immunol. 2018 May;120(5):504-511.e4. doi: 10.1016/j.anai.2018.01.030. Epub 2018 Feb 1.

Results Reference

derived

PubMed Identifier

27609408

Citation

Bleecker ER, FitzGerald JM, Chanez P, Papi A, Weinstein SF, Barker P, Sproule S, Gilmartin G, Aurivillius M, Werkstrom V, Goldman M; SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet. 2016 Oct 29;388(10056):2115-2127. doi: 10.1016/S0140-6736(16)31324-1. Epub 2016 Sep 5.

Results Reference

derived

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1845&filename=D3250C00017_Revised_CSP_SIROCCO.pdf

Description

D3250C00017CSP3redacted

Learn more about this trial

Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

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Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

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