study to evaluate the efficacy and safety of medi-563 in adults with uncontrolled asthma

Conditions: Asthma

Summary: the primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of medi-563 on adults with uncontrolled asthma.

this is a phase 2b, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of multiple-dose (7 doses) subcutaneous administration of benralizumab (medi-563) in adult subjects with uncontrolled asthma.

Eligibility criteria:
inclusion criteria: * age 18 through 75 years at the time of screening * adequate contraception from screening through end of trial * weight of more than (\>) 45 kilogram (kg) but less than or equal to (\ 100 pound \[lb\] but \<=330 lb) * history of physician-diagnosed asthma for at least 12 months prior to screening * physician prescribed daily use of medium-dose or high-dose inhaled corticosteroid(s) (ics) plus long-acting beta 2 agonist (laba) for at least 12 months prior to screening * willingness to switch to an ics/laba combination product * dose of other asthma controller medications must be stable for at least 30 days prior to screening * at least 2 documented asthma exacerbations in the 12 months prior to screening that required use of a systemic corticosteroid burst * for subjects 65 years of age or older, a chest x-ray (cxr) or chest computed tomography (ct) that is normal for an asthmatic population * ability and willingness to complete the study to week 66, and if needed to week 92. exclusion criteria: * known history of allergy or reaction to any component of the investigational product formulation * history of anaphylaxis to any biologic therapy * unexplained diarrhea within 30 days prior to screening or diagnosis of helminth parasitic infestation within 6 months prior to screening * use of immunosuppressive medication within 3 months prior to screening. chronic oral prednisone or equivalent up to 10 milligram (mg) daily or 20 mg every other day for asthma is allowed * oral corticosteroid burst or short-acting systemic corticosteroid within 30 days prior to screening or during the screening/run-in period * acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to the screening or during the screening/run-in period * receipt of immunoglobulin or blood products within 30 days prior to screening * receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to screening, whichever is longer * receipt of any investigational nonbiologic within 30 days or 5 half-lives prior to screening, whichever is longer * previously received medi-563 * any clinically relevant abnormal findings in physical examination * past history of clinically significant cardiac disease or any electrocardiogram (ecg) abnormality * breastfeeding or lactating women * history of alcohol or drug abuse within 12 months prior to screening * history of any known primary immunodeficiency disorder * positive medical history for hepatitis b or c. subjects with a history of hepatitis b vaccination without history of hepatitis b are allowed to enrol * a positive human immunodeficiency virus (hiv) test or subject taking antiretroviral medications * history of cigarette smoking more than or equal to (\>=) 10 pack-years or smoking within 12 months prior to screening. * known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma * history of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy \>=12 months prior to screening or other malignancies treated with apparent success with curative therapy \>=5 years prior to screening * stable dose of allergy vaccination regimen for less than 30 days prior to screening * subjects unable to demonstrate acceptable inhaler and peak flow meter techniques.

Keywords: asthma benralizumab medi-563