None listed
Conditions
Interventions
Benralizumab 30 mg/mL solution for injection in an accessorized pre-filled syringe (PFS) will be administered at the study centre subcutaneously every 4 weeks for the first 3 doses and then every 4 or
Sponsors
ASTRAZENECA - PERU,
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 3.1 Inclusion criteria For inclusion in the study patients must fulfil all of the following criteria: 1. Provision of informed consent prior to any study specific procedures 2. Female and male aged from 18 to 75 years, inclusively 3. Women of childbearing potential (WOCBP) must use a highly effective form of birth control (confirmed by the Investigator). Highly effective forms of birth control includes: true sexual abstinence, a vasectomised sexual partner, Implanon, female sterilization by tubal occlusion, any effective IUD Intrauterine device/IUS Ievonorgestrel Intrauterine system, Depo-Provera™ injections, oral contraceptive, and Evra Patch ™ or Nuvaring™. WOCBP must agree to use highly effective method of birth control, as defined above, from enrolment, throughout the study duration and within 16 weeks after last dose of IP, and have negative serum pregnancy test result on Visit 1. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postemenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply:  Women 250μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1. Equivalents for fluticasone dry powder can be found in Appendix E 7. Documented treatment with medium-dose ICS (>250μg and 12% and >200 mL in FEV1 within 12 months prior to planned date of randomization 13. A peripheral blood eosinophil count ≥300/µl during screening (Visit 3, Week -1) Inclusion
Exclusion criteria
Exclusion criteria: 3.2 Exclusion criteria Patients must not enter the study if any of the following exclusion criteria are fulfilled: 1. Clinically important pulmonary disease other than asthma (eg, 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 (eg, 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. Known history of allergy or reaction to the investigational product formulation 4. History of anaphylaxis to any biologic therapy 5. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy 6. 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 7. 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 8. Any clinically significant cardiac disease or any ECG abnormality obtained during the screening/run-in period, which in the opinion of the Investigator may put the patient at risk or interfere with study assessments 9. History of alcohol or drug abuse within 12 months prior to the date informed consent is obtained 10. Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Patients with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol 11. A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test 12. Current smokers or former smokers with a smoking history of > 10 pack-years 13. History of cancer:  Patients who have had basal cell carcinoma, or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained  Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained 14. Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, intramuscular long-a
Countries
Argentina, Brazil, Bulgaria, Germany, Mexico, Poland, Russian Federation, South Africa, Sweden, Turkey, Ukraine, United States
Contacts
Public ContactUrsula Rodriguez-Frias
ASTRAZENECA PERU S.A.
Outcome results
None listed