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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01928771




Registration number
NCT01928771
Ethics application status
Date submitted
16/08/2013
Date registered
27/08/2013
Date last updated
3/05/2017

Titles & IDs
Public title
Efficacy and Safety Study of Benralizumab Added to High-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma
Scientific 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 ß2 Agonist in Patients With Uncontrolled Asthma
Secondary ID [1] 0 0
D3250C00017
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Benralizumab
Other interventions - Placebo

Experimental: Benralizumab 30 mg q.4 weeks - Benralizumab administered subcutaneously every 4 weeks

Experimental: Benralizumab 30 mg q.8 weeks - Benralizumab administered subcutaneously every 8 weeks

Placebo Comparator: Placebo - Placebo administered subcutaneously


Other interventions: Benralizumab
Benralizumab subcutaneously on study week 0 until study week 44 inclusive.

Other interventions: Placebo
Placebo subcutaneously on study week 0 until study week 44 inclusive.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL
Timepoint [1] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [1] 0 0
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils < 300/uL
Timepoint [1] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [2] 0 0
Annual Asthma Exacerbation Rate Resulting Emergency Room Visits and Hospitalizations
Timepoint [2] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [3] 0 0
Number of Patients With >=1 Asthma Exacerbations
Timepoint [3] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [4] 0 0
Time to First Asthma Exacerbation
Timepoint [4] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [5] 0 0
Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils >=300/uL
Timepoint [5] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [6] 0 0
Mean Change From Baseline to Week 48 in Pre-bronchodilator FEV1 (L) Value for Baseline Eosinophils <300/uL
Timepoint [6] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [7] 0 0
Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils >=300/uL
Timepoint [7] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [8] 0 0
Mean Change From Baseline to Week 48 in Asthma Symptom Score for Baseline Eosinophils <300/uL
Timepoint [8] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [9] 0 0
Change in Asthma Rescue Medication
Timepoint [9] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [10] 0 0
Home Lung Function Assessment Based on Morning PEF
Timepoint [10] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [11] 0 0
Home Lung Function Assessment Based on Evening PEF
Timepoint [11] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [12] 0 0
Proportion of Night Awakening Due to Asthma
Timepoint [12] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [13] 0 0
Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils >=300/uL
Timepoint [13] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [14] 0 0
Mean Change From Baseline to Week 48 in ACQ-6 for Baseline Eosinophils <300/uL
Timepoint [14] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [15] 0 0
Pharmacokinetics of Benralizumab
Timepoint [15] 0 0
Baseline, week 4, week 4 day 6, week 8, week 16, week 24, week 32, week 40, week 48, week 56
Secondary outcome [16] 0 0
Immunogenicity of Benralizumab
Timepoint [16] 0 0
Pre-treatment until end of follow-up
Secondary outcome [17] 0 0
Extend of Exposure
Timepoint [17] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [18] 0 0
Mean Change From Baseline to Week 48 in AQLQ(S)+12
Timepoint [18] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [19] 0 0
Mean Change From Baseline to Week 48 in EQ-5D-5L VAS
Timepoint [19] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [20] 0 0
Mean Work Productivity Loss Due to Asthma
Timepoint [20] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [21] 0 0
Mean Productivity Loss Due to Asthma in Classroom
Timepoint [21] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [22] 0 0
Number of Participants That Utilized Health Care Resources
Timepoint [22] 0 0
Immediately following the first administration of study drug through Study Week 48.
Secondary outcome [23] 0 0
Patient and Clinician's Responder Assessment to Treatment
Timepoint [23] 0 0
Immediately following the first administration of study drug through Study Week 48

Eligibility
Key inclusion criteria
1. 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.

2. 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.

3. 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

4. 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.
Minimum age
12 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

1. 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)

2. 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

3. 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

4. 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

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

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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/04/2016
Sample size
Target
Accrual to date
Final
2681
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - Box Hill
Recruitment hospital [3] 0 0
Research Site - Clayton
Recruitment hospital [4] 0 0
Research Site - Concord
Recruitment hospital [5] 0 0
Research Site - Frankston
Recruitment hospital [6] 0 0
Research Site - Nedlands
Recruitment hospital [7] 0 0
Research Site - New Lambton Heights
Recruitment hospital [8] 0 0
Research Site - Parkville
Recruitment hospital [9] 0 0
Research Site - Prahran
Recruitment hospital [10] 0 0
Research Site - Randwick
Recruitment hospital [11] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Clayton
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- Concord
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- Frankston
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- Nedlands
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- New Lambton Heights
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- Parkville
Recruitment postcode(s) [9] 0 0
- Prahran
Recruitment postcode(s) [10] 0 0
- Randwick
Recruitment postcode(s) [11] 0 0
- Woolloongabba
Recruitment outside Australia
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Chertsey
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Chester
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Chippenham
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Cottingham
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Darlington
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Glasgow
Country [179] 0 0
United Kingdom
State/province [179] 0 0
High Heaton/Newcastle upon Tyn
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Leeds
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Liverpool
Country [182] 0 0
United Kingdom
State/province [182] 0 0
London
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Maidstone
Country [184] 0 0
United Kingdom
State/province [184] 0 0
Manchester
Country [185] 0 0
United Kingdom
State/province [185] 0 0
Nottingham
Country [186] 0 0
United Kingdom
State/province [186] 0 0
Plymouth
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Portsmouth
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Soham
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Somerset
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Stevenage
Country [191] 0 0
United Kingdom
State/province [191] 0 0
Stockton
Country [192] 0 0
Vietnam
State/province [192] 0 0
Hanoi
Country [193] 0 0
Vietnam
State/province [193] 0 0
Ho Chi Minh

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether Benralizumab reduces the number of asthma
exacerbations in patients who remain uncontrolled on high doses of ICS-LABA.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01928771
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eugene R. Bleecker, MD, Professor of Medicine
Address 0 0
Center for Genomics and Personalized Medicine Research, Medical Center Boulevard, Winston-Salem, North Carolina 27157
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries