Resumen

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

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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 (\<=) 150 kg (\>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.

Criterios de exclusión

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.

Intervenciones

biological

Benralizumab 2 mg

EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.

biological

Benralizumab 20 mg

EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.

biological

Benralizumab 100 mg

EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.

other

Placebo

EOS+ and EOS- participants received two placebo injections subcutaneously.

A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Benralizumab 2 mg

Benralizumab 20 mg

Benralizumab 100 mg

Placebo

Ubicaciones

Research Site

Research Site

Research Site

Research Site

Patrocinadores