Brief Summary
The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA, NCT02258542).
Brief Title
A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist
Detailed Description
This is an open-label safety extension study designed to evaluate the safety and tolerability of a fixed 30 mg dose of benralizumab administered subcutaneously (SC) in severe asthma patients on inhaled corticosteroid and long-acting β2 agonist (ICS-LABA) therapy with or without chronic oral corticosteroids (OCS) and/or other asthma controllers. All patients will receive active drug on the same dosing regimen they received in BORA (NCT02258542). In order to protect the blind of BORA, patients will remain blinded to treatment regimen allocation until they have completed all end of treatment (EOT) assessments in BORA and signed informed consent for participation in this study, after which treatment allocation will be unblinded to both the investigator and the patient.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Asthma
Eligibility Criteria
Inclusion Criteria:
* Informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union guidelines.
* Female and male patients who have completed at least 16 and not more than 40 weeks in Study D3250C00021.
* Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after the last dose of Investigational Product (IP)
* For WOCBP only: Have a negative urine pregnancy test prior to administration of 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, hematological, 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 study 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 required hospitalization, has 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, ECG, hematology, clinical chemistry, or urinalysis during the 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 the 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 IP
* 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 drug-related interventional clinical trial
* AstraZeneca staff involved in the planning and/or conduct of the study
* Employees of the study center or any other individuals involved with the conduct of the study or immediate family members of such individuals
* Patients with important protocol deviations in the predecessor study at the discretion of the Sponsor
* Patients with ongoing serious adverse events (SAEs) from the prior study should not be enrolled into the this extension study until the SAE has resolved
* Informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union guidelines.
* Female and male patients who have completed at least 16 and not more than 40 weeks in Study D3250C00021.
* Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after the last dose of Investigational Product (IP)
* For WOCBP only: Have a negative urine pregnancy test prior to administration of 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, hematological, 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 study 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 required hospitalization, has 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, ECG, hematology, clinical chemistry, or urinalysis during the 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 the 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 IP
* 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 drug-related interventional clinical trial
* AstraZeneca staff involved in the planning and/or conduct of the study
* Employees of the study center or any other individuals involved with the conduct of the study or immediate family members of such individuals
* Patients with important protocol deviations in the predecessor study at the discretion of the Sponsor
* Patients with ongoing serious adverse events (SAEs) from the prior study should not be enrolled into the this extension study until the SAE has resolved
Inclusion Criteria
Inclusion Criteria:
* Informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union guidelines.
* Female and male patients who have completed at least 16 and not more than 40 weeks in Study D3250C00021.
* Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after the last dose of Investigational Product (IP)
* For WOCBP only: Have a negative urine pregnancy test prior to administration of 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.
* Informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union guidelines.
* Female and male patients who have completed at least 16 and not more than 40 weeks in Study D3250C00021.
* Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after the last dose of Investigational Product (IP)
* For WOCBP only: Have a negative urine pregnancy test prior to administration of 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.
Gender
All
Gender Based
false
Keywords
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases
Obstructive Lung Diseases
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
130 Years
Minimum Age
18 Years
NCT Id
NCT02808819
Org Class
Industry
Org Full Name
AstraZeneca
Org Study Id
D3250C00037
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Multicenter, Open-label, Safety Extension Study With Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)
Primary Outcomes
Outcome Description
Change from baseline in hematologic lab parameter of Basophils.
Outcome Measure
Change From Baseline in Basophils, Full Analysis Set
Outcome Time Frame
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Outcome Description
Change from baseline in hematologic lab parameter of Leukocytes.
Outcome Measure
Change From Baseline in Leukocytes, Full Analysis Set
Outcome Time Frame
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Outcome Description
Change from baseline in hematologic lab parameter of Lymphocytes.
Outcome Measure
Change From Baseline in Lymphocytes, Full Analysis Set
Outcome Time Frame
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Outcome Description
Change from baseline in hematologic lab parameter of Neutrophils.
Outcome Measure
Change From Baseline in Neutrophils, Full Analysis Set
Outcome Time Frame
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Outcome Description
Change from baseline in hematologic lab parameter of Monocytes.
Outcome Measure
Change From Baseline in Monocytes, Full Analysis Set
Outcome Time Frame
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Outcome Description
Change from baseline in hematologic lab parameter of Platelets.
Outcome Measure
Change From Baseline in Platelets, Full Analysis Set
Outcome Time Frame
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Outcome Description
Change from baseline in hematologic lab parameter of Hematocrit.
Outcome Measure
Change From Baseline in Hematocrit, Full Analysis Set
Outcome Time Frame
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Outcome Description
Change from baseline in hematologic lab parameter of Erythrocytes.
Outcome Measure
Change From Baseline in Erythrocytes, Full Analysis Set
Outcome Time Frame
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Outcome Description
Change from baseline in hematologic lab parameter of Hemoglobin.
Outcome Measure
Change From Baseline in Hemoglobin, Full Analysis Set
Outcome Time Frame
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Outcome Description
Change from baseline in chemistry test ALT.
Outcome Measure
Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set
Outcome Time Frame
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Outcome Description
Change from baseline in chemistry test AST.
Outcome Measure
Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set
Outcome Time Frame
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Outcome Description
Change from baseline in chemistry test Bilirubin.
Outcome Measure
Change From Baseline in Bilirubin, Full Analysis Set
Outcome Time Frame
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Secondary Outcomes
Outcome Description
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
Outcome Time Frame
From week 0 to week 184 in study treatment period and through the follow up period (12 weeks from day of last dose). Number and percentage of participants with asthma exacerbation during this period is presented.
Outcome Measure
Number of Participants With Asthma Exacerbations During Study Period
Outcome Description
Hospitalizations, Emergency department (ED) visits, urgent care visits and all other outpatient visits due to asthma
Outcome Time Frame
From week 0 to week 184 in study treatment period and through the follow up period (12 weeks from day of last dose). Number and percentage of participants with health care encounters during this period is presented.
Outcome Measure
Number of Participants Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period
Outcome Description
Change from Baseline to End of Treatment in blood eosinophils count.
Outcome Time Frame
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Outcome Measure
Change of Blood Eosinophils Count
Outcome Description
Assessments for the presence of ADA and neutralizing antibody (nAb) throughout study
Outcome Time Frame
From week 0 to week 184 in study treatment period and plus 12 weeks follow up period
Outcome Measure
Number of Participants With Anti-drug Antibodies (ADA) Responses During the Study
Outcome Description
Duration of exposure
Outcome Time Frame
From week 0 to week 184 in study treatment period
Outcome Measure
Duration of Exposure
See Also Links
Url
Url
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
130
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Golda Hudes
Investigator Email
ghudes@montefiore.org
Investigator Phone
646-229-9509
Categories Mesh Debug
Asthma and Other Respiratory Diseases --- BRONCHIAL DISEASES
Lung --- BRONCHIAL DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Lung --- LUNG DISEASES, OBSTRUCTIVE
Asthma and Other Respiratory Diseases --- RESPIRATORY HYPERSENSITIVITY
Lung --- RESPIRATORY HYPERSENSITIVITY
Lung --- HYPERSENSITIVITY, IMMEDIATE
Lung --- HYPERSENSITIVITY
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
ASTHMA
BRONCHIAL DISEASES
RESPIRATORY TRACT DISEASES
LUNG DISEASES
LUNG DISEASES, OBSTRUCTIVE
RESPIRATORY HYPERSENSITIVITY
HYPERSENSITIVITY, IMMEDIATE
HYPERSENSITIVITY
IMMUNE SYSTEM DISEASES
BENRALIZUMAB