Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.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.2. Female and male patients who have completed at least 16 and not more than 40 weeks in Study D3250C00021.3.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 IP. 4.For WOCBP only: Have a negative urine pregnancy test prior to administration of IP at Visit 1. 5.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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1050 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. 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. 2. 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. 3. 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. 4. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of 2 dosing regimens of benralizumab for adult patients ;Secondary Objective: • To evaluate the effect of 2 dosing regimens of benralizumab on asthma exacerbations, and asthma-related hospitalizations and emergency room visits • To evaluate the pharmacodynamics and immunogenicity of 2 dosing regimens of benralizumab for adult patients ;Primary end point(s): Number of Adverse Events/Serious Adverse Events (AEs/SAEs);Timepoint(s) of evaluation of this end point: around 108 weeks, around 108 weeks, duration will differ based on time of local BLA approval | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Asthma exacerbations • Asthma-related hospitalizations and emergency room visits. • Eosinophil levels • Anti-drug antibodies (ADA) ;Timepoint(s) of evaluation of this end point: around 108 weeks, around 108 weeks, duration will differ based on time of local BLA approval | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Czech Republic, France, Germany, Peru, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States, Vietnam
Contacts
Public ContactClinical Trial Transparency
AstraZeneca AB
Outcome results
None listed