A Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES)  (NATRON)

Recruitment Status:
Recruiting

Sponsor:
AstraZeneca

Information Provided by (Responsible Party):
AstraZeneca

ClinicalTrials.gov Identifier:
NCT04191304

Verification:
Verified 01 November 2022   by AstraZeneca

History of Changes:
ClinicalTrials.gov

Purpose

This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase 3 study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This study comprises 2 distinct periods (together defined as the ‘main study’): A 24-week, DB treatment period, during which patients will be randomised to receive either benralizumab or placebo, in addition to prior stable HES background therapy, and an open-label (OLE) treatment period, during which all patients will receive benralizumab. Patients will not continue to be recruited after 47 patients have had their first HES worsening/flare.The primary database lock (DBL) will occur when at least 47 patients have had their first HES worsening/flare event and all randomised patients have been followed up for the 24-week DB treatment period. The target patient population is male and female patients 12 years of age and older with symptomatic active HES. Approximately 120 eligible patients will be randomised at a 1:1 ratio to receive either benralizumab or matching placebo

Official Title:A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES)
Study Type:Interventional
Overall Recruitment Status:Recruiting
Study Start Date:22 July 2020
Study Start Date Type:Actual
Primary Completion Date:02 November 2023
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking Description: All eligible patients will be centrally randomly assigned in a 1:1 ratio to receive either benralizumab or placebo. Randomisation will be done using an IWRS/IVRS. Benralizumab and placebo will not be visually distinct from each other. All packaging and labelling of the IP will be done in such a way as to ensure blinding for all Sponsor and investigational site staff. Neither the patient nor any of the Investigators or Sponsor staff who are involved in the treatment, clinical evaluation, and monitoring of the patients will be aware of the treatment received. Since benralizumab and placebo are not visually distinct, IP will be handled by an appropriately qualified member of the study team (e.g., pharmacist, Investigator, or designee) at the site.
ConditionInterventionPhase
Hypereosinophilic Syndrome
Biological/Vaccine: Benralizumab
Biological/Vaccine: Placebo
Phase 3
Ages Eligible for Study: 12 Years  to 130 Years
Genders Eligible for Study: Both
Gender Based: No
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:
1 Provision of the signed and dated written informed consent of the patient or the patient’s
legally authorised representative, and informed assent from the patient (per local
regulations) prior to any mandatory study-specific procedures, sampling, and analyses.
2 Males and females 12 years of age and older at the time of signing the ICF.
3 Documented diagnosis of HES (history of persistent eosinophilia >1500 cells/μL without
secondary cause on 2 examinations [interval ≥1 month; Valent et al 2012] and evidence of
end organ manifestations attributable to the eosinophilia).
4 Documented negative testing for the FIP1L1-PDGFRA fusion tyrosine kinase gene
translocation.
5 Stable HES treatment dose(s) and regimen for ≥4 weeks at the time of Visit 1
6 Signs or symptoms of HES worsening/flare and/or laboratory abnormalities indicative of
HES worsening/flare (other than isolated eosinophilia) at Visit 1.
7 AEC ≥1000 cells/μL at Visit 1 (assessed by local laboratory).
8 Corticosteroid responsiveness defined as an AEC <1000 cells/μL after a 2-day course of
OCS 1 mg/kg/day at Visit 2 (assessed by local laboratory).
9 Women of childbearing potential (WOCBP) must agree to use a highly effective method
of birth control (confirmed by the Investigator) from enrolment, throughout the study
duration, and within 12 weeks after last dose of IP and have a negative urine
dipstick pregnancy test result on Visit 1

Exclusion Criteria:
1 Life-threatening HES and/or HES complication(s) as judged by the Investigator:
(a) Medical intervention for HES-related life-threatening event(s) within 12 weeks prior
to randomisation OR
(b) History of thrombotic complications, stroke, or significant cardiac damage related to
HES, if the respective events were life threatening and currently represent a risk of life-threatening disease complications. Events that occurred in the past but considered resolved or stable, can be accepted if, as per Investigator's judgment
participation in the study will not put the patient at risk
(c) Disease severity that, in the opinion of the Investigator, makes the patient
inappropriate for inclusion in the study.
2 Presence of FIP1L1-PDGFRA fusion tyrosine kinase gene translocation or other known
imatinib-sensitive mutation.
3 Definitive diagnosis of eosinophilic granulomatosis with polyangiitis.
4 Known, pre-existing, clinically significant endocrine, autoimmune, metabolic,
neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any other
system abnormalities that are not associated with HES and are uncontrolled with standard
treatment 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 the entire duration of the study.
5 Hypereosinophilia of unknown significance.
6 Cardiovascular: Documented history of any clinically significant cardiac damage, clinically significant echocardiography (if available) or ECG findings within 12 months
prior to Visit 1 or clinically significant ECG findings at screening that, in the opinion of the Investigator, may put the patients at risk.
7 Known currently active liver disease.
(a) Chronic stable hepatitis B and C (including positive testing for hepatitis B surface
antigen or hepatitis C antibody) or other stable chronic liver disease are acceptable if patient otherwise meets eligibility criteria. Stable chronic liver disease should
generally be defined by the absence of ascites, encephalopathy, coagulopathy,
hypoalbuminemia, oesophageal or gastric varices, or persistent jaundice, or cirrhosis.
(b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3× the
upper limit of normal (ULN) during the screening period (AST or ALT >5×ULN if
documented HES with liver manifestations). Transient increase of AST/ALT level
that resolves by the time of randomisation is acceptable if, in the Investigator’s
opinion, the patient does not have an active liver disease and meets other eligibility
criteria.
8 Current malignancy, or history of malignancy, except:
(a) Patients who have had basal cell carcinoma, localised squamous cell carcinoma of the
skin, or in situ carcinoma of the cervix are eligible provided the patient is in
remission and curative therapy was completed at least 12 months prior to the date that
informed consent, and assent when applicable, was obtained.
(b) Patients who have had other malignancies are eligible provided the patient is in
remission and curative therapy was completed at least 5 years prior to the date
informed consent, and assent when applicable, was obtained.
9 Diagnosis of systemic mastocytosis.
10 Chronic or ongoing active infections requiring systemic treatment, as well as clinically
significant viral, bacterial, or fungal infection within 4 weeks prior to Visit 1.


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    [email protected]  

Sponsors and Collaborators

AstraZeneca


Locations

CountryLocationFacilityContactStatus
JPResearch Site Bunkyo-ku, JP, 113-8431Recruiting
JPResearch Site Chiba-shi, JP, 260-0852Recruiting
JPResearch Site Hamamatsu-shi, JP, 431-3192Recruiting
JPResearch Site Ichikawa-shi, JP, 272-8516Recruiting
JPResearch Site Kawasaki-shi, JP, 211-8510Recruiting
JPResearch Site Nishinomiya-shi, JP, 663-8501Recruiting
JPResearch Site Osaka-shi, JP, 530-8480Recruiting
JPResearch Site Sendai-shi, JP, 980-8574Recruiting
US , OHResearch Site Cleveland, OH, US, 44106Recruiting
US , OHResearch Site Columbus, OH, US, 43212Recruiting
BEResearch Site Brussels, BE, 1070Recruiting
BEResearch Site Edegem, BE, 2650Recruiting
BEResearch Site Leuven, BE, 3000Recruiting
DEResearch Site Hannover, DE, 30625Recruiting
DEResearch Site Kirchheim, DE, 73230Recruiting
DEResearch Site Mannheim, DE, 68167Recruiting
CHResearch Site Bern, CH, 3010Recruiting
CHResearch Site Zürich, CH, 8091Withdrawn
US , GAResearch Site Atlanta, GA, US, 30324Recruiting
US , CAResearch Site La Jolla, CA, US, 92037Recruiting
US , MIResearch Site Ann Arbor, MI, US, 48105Recruiting
ITResearch Site Bologna, IT, 40138Recruiting
ITResearch Site Milano, IT, 20132Recruiting
FRResearch Site LILLE CEDEX, FR, 59037Recruiting
FRResearch Site PESSAC, FR, 33604Recruiting
FRResearch Site Strasbourg, FR, 67091Recruiting
FRResearch Site Suresnes, FR, 92150Recruiting
FRResearch Site Toulouse Cedex 9, FR, 31059Recruiting
ILResearch Site Haifa, IL, 34362Recruiting
ILResearch Site Holon, IL, 58100Recruiting
ILResearch Site Jerusalem, IL, 91120Recruiting
ILResearch Site Kfar Saba, IL, 44218Recruiting
ILResearch Site Petah Tiqva, IL, 49100Recruiting
ILResearch Site Ramat Gan, IL, 5265601Recruiting
ILResearch Site Rehovot, IL, 76100Recruiting
ILResearch Site Tel-Aviv, IL, 64239Recruiting
PLResearch Site Gdańsk, PL, 80-214Recruiting
PLResearch Site Łódź, PL, 90-153Recruiting
US , NCResearch Site Durham, NC, US, 27705Recruiting
US , WIResearch Site Milwaukee, WI, US, 53226Recruiting
ATResearch Site Innsbruck, AT, 6020Recruiting
US , MNResearch Site Rochester, MN, US, 55905-0001Recruiting
US , MDResearch Site Bethesda, MD, US, 20892Recruiting
US , UTResearch Site Salt Lake City, UT, US, 84112Recruiting
DKResearch Site København Ø, DK, 2100Recruiting
NLResearch Site Rotterdam, NL, 3015 GDRecruiting

 File nameDescription
The study website.The study website.
This is a one-page brochure on Natron study.This is a one-page brochure on Natron study.
.

Purpose

This is a multicentre, randomised, double-blind (DB), parallel-group, placebo-controlled, 24-week Phase 3 study to compare the efficacy and safety of benralizumab versus placebo administered by SC injection Q4W in patients with hypereosinophilic syndrome (HES). This study comprises 2 distinct periods (together defined as the ‘main study’): A 24-week, DB treatment period, during which patients will be randomised to receive either benralizumab or placebo, in addition to prior stable HES background therapy, and an open-label (OLE) treatment period, during which all patients will receive benralizumab. Patients will not continue to be recruited after 47 patients have had their first HES worsening/flare.The primary database lock (DBL) will occur when at least 47 patients have had their first HES worsening/flare event and all randomised patients have been followed up for the 24-week DB treatment period. The target patient population is male and female patients 12 years of age and older with symptomatic active HES. Approximately 120 eligible patients will be randomised at a 1:1 ratio to receive either benralizumab or matching placebo

Official Title:A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 24-week Phase 3 Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients with Hypereosinophilic Syndrome (HES)
Study Type:Interventional
Overall Recruitment Status:Recruiting
Study Start Date:22 July 2020
Study Start Date Type:Actual
Primary Completion Date:02 November 2023
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking Description: All eligible patients will be centrally randomly assigned in a 1:1 ratio to receive either benralizumab or placebo. Randomisation will be done using an IWRS/IVRS. Benralizumab and placebo will not be visually distinct from each other. All packaging and labelling of the IP will be done in such a way as to ensure blinding for all Sponsor and investigational site staff. Neither the patient nor any of the Investigators or Sponsor staff who are involved in the treatment, clinical evaluation, and monitoring of the patients will be aware of the treatment received. Since benralizumab and placebo are not visually distinct, IP will be handled by an appropriately qualified member of the study team (e.g., pharmacist, Investigator, or designee) at the site.
ConditionInterventionPhase
Hypereosinophilic Syndrome
Biological/Vaccine: Benralizumab
Biological/Vaccine: Placebo
Phase 3
Ages Eligible for Study: 12 Years  to 130 Years
Genders Eligible for Study: Both
Gender Based: No
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:
1 Provision of the signed and dated written informed consent of the patient or the patient’s
legally authorised representative, and informed assent from the patient (per local
regulations) prior to any mandatory study-specific procedures, sampling, and analyses.
2 Males and females 12 years of age and older at the time of signing the ICF.
3 Documented diagnosis of HES (history of persistent eosinophilia >1500 cells/μL without
secondary cause on 2 examinations [interval ≥1 month; Valent et al 2012] and evidence of
end organ manifestations attributable to the eosinophilia).
4 Documented negative testing for the FIP1L1-PDGFRA fusion tyrosine kinase gene
translocation.
5 Stable HES treatment dose(s) and regimen for ≥4 weeks at the time of Visit 1
6 Signs or symptoms of HES worsening/flare and/or laboratory abnormalities indicative of
HES worsening/flare (other than isolated eosinophilia) at Visit 1.
7 AEC ≥1000 cells/μL at Visit 1 (assessed by local laboratory).
8 Corticosteroid responsiveness defined as an AEC <1000 cells/μL after a 2-day course of
OCS 1 mg/kg/day at Visit 2 (assessed by local laboratory).
9 Women of childbearing potential (WOCBP) must agree to use a highly effective method
of birth control (confirmed by the Investigator) from enrolment, throughout the study
duration, and within 12 weeks after last dose of IP and have a negative urine
dipstick pregnancy test result on Visit 1

Exclusion Criteria:
1 Life-threatening HES and/or HES complication(s) as judged by the Investigator:
(a) Medical intervention for HES-related life-threatening event(s) within 12 weeks prior
to randomisation OR
(b) History of thrombotic complications, stroke, or significant cardiac damage related to
HES, if the respective events were life threatening and currently represent a risk of life-threatening disease complications. Events that occurred in the past but considered resolved or stable, can be accepted if, as per Investigator's judgment
participation in the study will not put the patient at risk
(c) Disease severity that, in the opinion of the Investigator, makes the patient
inappropriate for inclusion in the study.
2 Presence of FIP1L1-PDGFRA fusion tyrosine kinase gene translocation or other known
imatinib-sensitive mutation.
3 Definitive diagnosis of eosinophilic granulomatosis with polyangiitis.
4 Known, pre-existing, clinically significant endocrine, autoimmune, metabolic,
neurological, renal, gastrointestinal, hepatic, haematological, respiratory, or any other
system abnormalities that are not associated with HES and are uncontrolled with standard
treatment 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 the entire duration of the study.
5 Hypereosinophilia of unknown significance.
6 Cardiovascular: Documented history of any clinically significant cardiac damage, clinically significant echocardiography (if available) or ECG findings within 12 months
prior to Visit 1 or clinically significant ECG findings at screening that, in the opinion of the Investigator, may put the patients at risk.
7 Known currently active liver disease.
(a) Chronic stable hepatitis B and C (including positive testing for hepatitis B surface
antigen or hepatitis C antibody) or other stable chronic liver disease are acceptable if patient otherwise meets eligibility criteria. Stable chronic liver disease should
generally be defined by the absence of ascites, encephalopathy, coagulopathy,
hypoalbuminemia, oesophageal or gastric varices, or persistent jaundice, or cirrhosis.
(b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3× the
upper limit of normal (ULN) during the screening period (AST or ALT >5×ULN if
documented HES with liver manifestations). Transient increase of AST/ALT level
that resolves by the time of randomisation is acceptable if, in the Investigator’s
opinion, the patient does not have an active liver disease and meets other eligibility
criteria.
8 Current malignancy, or history of malignancy, except:
(a) Patients who have had basal cell carcinoma, localised squamous cell carcinoma of the
skin, or in situ carcinoma of the cervix are eligible provided the patient is in
remission and curative therapy was completed at least 12 months prior to the date that
informed consent, and assent when applicable, was obtained.
(b) Patients who have had other malignancies are eligible provided the patient is in
remission and curative therapy was completed at least 5 years prior to the date
informed consent, and assent when applicable, was obtained.
9 Diagnosis of systemic mastocytosis.
10 Chronic or ongoing active infections requiring systemic treatment, as well as clinically
significant viral, bacterial, or fungal infection within 4 weeks prior to Visit 1.


Contacts

Contact: AstraZeneca Clinical  Study Information Center   1-877-240-9479    [email protected]  

Sponsors and Collaborators

AstraZeneca


Locations

CountryLocationFacilityContactStatus
JPResearch Site Bunkyo-ku, JP, 113-8431Recruiting
JPResearch Site Chiba-shi, JP, 260-0852Recruiting
JPResearch Site Hamamatsu-shi, JP, 431-3192Recruiting
JPResearch Site Ichikawa-shi, JP, 272-8516Recruiting
JPResearch Site Kawasaki-shi, JP, 211-8510Recruiting
JPResearch Site Nishinomiya-shi, JP, 663-8501Recruiting
JPResearch Site Osaka-shi, JP, 530-8480Recruiting
JPResearch Site Sendai-shi, JP, 980-8574Recruiting
US , OHResearch Site Cleveland, OH, US, 44106Recruiting
US , OHResearch Site Columbus, OH, US, 43212Recruiting
BEResearch Site Brussels, BE, 1070Recruiting
BEResearch Site Edegem, BE, 2650Recruiting
BEResearch Site Leuven, BE, 3000Recruiting
DEResearch Site Hannover, DE, 30625Recruiting
DEResearch Site Kirchheim, DE, 73230Recruiting
DEResearch Site Mannheim, DE, 68167Recruiting
CHResearch Site Bern, CH, 3010Recruiting
CHResearch Site Zürich, CH, 8091Withdrawn
US , GAResearch Site Atlanta, GA, US, 30324Recruiting
US , CAResearch Site La Jolla, CA, US, 92037Recruiting
US , MIResearch Site Ann Arbor, MI, US, 48105Recruiting
ITResearch Site Bologna, IT, 40138Recruiting
ITResearch Site Milano, IT, 20132Recruiting
FRResearch Site LILLE CEDEX, FR, 59037Recruiting
FRResearch Site PESSAC, FR, 33604Recruiting
FRResearch Site Strasbourg, FR, 67091Recruiting
FRResearch Site Suresnes, FR, 92150Recruiting
FRResearch Site Toulouse Cedex 9, FR, 31059Recruiting
ILResearch Site Haifa, IL, 34362Recruiting
ILResearch Site Holon, IL, 58100Recruiting
ILResearch Site Jerusalem, IL, 91120Recruiting
ILResearch Site Kfar Saba, IL, 44218Recruiting
ILResearch Site Petah Tiqva, IL, 49100Recruiting
ILResearch Site Ramat Gan, IL, 5265601Recruiting
ILResearch Site Rehovot, IL, 76100Recruiting
ILResearch Site Tel-Aviv, IL, 64239Recruiting
PLResearch Site Gdańsk, PL, 80-214Recruiting
PLResearch Site Łódź, PL, 90-153Recruiting
US , NCResearch Site Durham, NC, US, 27705Recruiting
US , WIResearch Site Milwaukee, WI, US, 53226Recruiting
ATResearch Site Innsbruck, AT, 6020Recruiting
US , MNResearch Site Rochester, MN, US, 55905-0001Recruiting
US , MDResearch Site Bethesda, MD, US, 20892Recruiting
US , UTResearch Site Salt Lake City, UT, US, 84112Recruiting
DKResearch Site København Ø, DK, 2100Recruiting
NLResearch Site Rotterdam, NL, 3015 GDRecruiting

Oversight


Is IND/IDE protocol: Yes 
IND/IDE Grantor: CDER 
IND/IDE Number: 141110 
Has Expanded Access: No 
U.S. FDA-regulated Drug: Yes 
U.S. FDA-regulated Device: No 

More Information


The study website.

This is a one-page brochure on Natron study.

No publications provided

Responsible Party:AstraZeneca
ClinicalTrials.gov Identifier:NCT04191304
Other Study ID Numbers:D3254C00001, 2019-002039-27

Keywords provided by AstraZeneca
benralizumab
Hypereosinophilic Syndrome (HES)

Additional Relevant MeSH terms:
Hypereosinophilic Syndrome

Primary Outcome Measures:

  • Time to first HES worsening/flare [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]
    An HES worsening or flare is defined as HES clinical manifestations or lab abnormalities that result in an increase/burst of OCS ≥10 mg/day for at least 2 days, OR in increase or addition of new cytotoxic and/or immunosuppressive therapy, OR hospitalisation

Secondary Outcome Measures:

  • Time to first haematologic relapse [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]
    A haematologic relapse is defined as AEC ≥1000 cells/μL

  • Proportion of patients who experience HES worsening/flare [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]

  • Proportion of patients who have haematologic relapse [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]

  • Proportion of patients who have AEC<500 cells/µL for 24 weeks [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]

  • Proportion of patients who require an increase in corticosteroid dose [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]

  • Change from baseline in fatigue [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]
    The PROMIS Fatigue Short Form 7a will be used which contains 7 questions assessing a range of patient-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one’s ability to execute daily activities and function normally in family or social roles

  • Change from baseline in HRQoL [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]
    Derived from the SF-36v2 questionnaires which contains 36 questions measuring patients’ general functional health and well-being, both physically and mentally

  • PGIS [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]
    The PGIS is a single question evaluating patients’ perception of overall symptom severity

  • PGIC [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]
    The PGIC is a single question evaluating whether there has been an improvement or decline in patients’ overall health status after start of treatment.

  • Serum benralizumab concentration as a measure of pharmacokinetics [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]

  • Anti-drug antibodies (ADA) titers and neutralizing antibodies (nAb) testing for all ADA-positive samples as measure of immunogenicity [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]

  • Percentage of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]

  • Change from baseline in systolic and diastolic blood pressure [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]

  • Change from baseline in pulse rate [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]

  • Change from baseline in respiratory rate [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]

  • Change from baseline in hematology parameters of hemoglobin, leukocytes, lymphocytes, monocytes, basophils, eosinophils, neutrophils, and platelets [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]

  • Change from baseline in clinical chemistry parameters of Alanine Aminotransferase (ALT), alkaline phosphatase, Aspartate Aminotransferase (AST), creatinine kinase, direct, indirect and total bilirubin, uric acid, albumin, creatinine and glucose [ Time Frame: Up to 24 weeks ] [ Designated as safety issue:  ]

Other Pre-specified Outcome Measures:

  • [ Time Frame:  ] [ Designated as safety issue:  ]

ArmsAssigned Interventions
Experimental: Benralizumab arm
1x Benralizumab SC injection
Biological/Vaccine: Benralizumab
Benralizumab solution for
injection in an accessorised prefilled
syringe (APFS) will be administered subcutaneously (SC) every 4 weeks
 
Placebo Comparator: Placebo arm
1x Benralizumab matching placebo SC injection
Biological/Vaccine: Placebo
Matching placebo solution for injection in an APFS will be administered SC every 4 weeks