Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis - MAHALE

Exclusion Criteria

• - Pulmonary disease other than bronchiectasis. Patients with a history of NTM disease may be enrolled if they have completed treatment prior to the Screening visit, if at least 3 months have elapsed since the last day of antibiotic treatment for NTM at the Screening visit, and if they have had a negative sputum culture prior to the screening visit.
• - Another diagnosed or suspected pulmonary or systemic disease associated with elevated peripheral eosinophil counts
• - Respiratory infection or bronchiectasis exacerbation during the screening period.
• - Any other clinical condition that is not stable in the opinion of the Investigator and could:
• a. Affect the safety of the patient during the study.
• b. Influence the findings of the study or their interpretation.
• c. Impede the patient’s ability to complete the entire duration of the study.
• - Radiological findings suggestive of a respiratory disease other than bronchiectasis, suggestive of acute infection, or of solitary pulmonary nodules without appropriate follow up and demonstration of stability as per standard of care. Pulmonary nodules > 6 mm in size should have at least 2 years of follow up with no change on CT imaging.
• - Current active liver disease
• - Current malignancy, or history of malignancy, except for:
• 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 Visit 1
• b. Patients who have had other malignancies are eligible provided that the participant is in remission and curative therapy was completed at least 5 years prior to Visit 1.
• - History of known immunodeficiency disorder including a positive test for human immunodeficiency virus, HIV-1 or HIV-2.
• - History of alcohol or drug abuse within the past year
• - Current smokers with a tobacco history of ≥ 10 pack-years or ex-smoker with a tobacco history of ≥ 10 pack-years.
• - Patients receiving long-term oxygen treatment
• - Patients participating in, or scheduled for, an intensive (active) pulmonary rehabilitation programme. Patients who are in the maintenance phase of a rehabilitation programme are eligible.
• - Use of non-invasive positive-pressure ventilation for conditions other than obstructive sleep apnoea
• - Use of immunosuppressive medication within 3 months of the screening visit or expected need for chronic use (≥ 4 weeks) during study
• - Receipt of any marketed or investigational biologic products (monoclonal or polyclonal antibody) within one year of the screening visit
• - Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to randomisation
• - Receipt of immunoglobulin and blood products within 30 days of the date of the screening visit
• - Receipt of live attenuated vaccines within 30 days of the date of randomisation
• - Concurrent enrolment in another clinical drug interventional trial
• - History of anaphylaxis to any biologic therapy or vaccine
• - Known history of allergy or reaction to any component of the IP formulation.
• - Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
• - Judgement by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements
• - Previous randomisation in the present study
• - Currently pregnant (confirmed with positive pregnancy test) or breast-feeding.