Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Benralizumab 2 mg; Benralizumab 20 mg; Benralizumab 100 mg; Placebo
Intervention description: EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.; EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.; EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.; EOS+ and EOS- participants received two placebo injections subcutaneously.
Intervention MeSH terms: Benralizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 964.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma; Benralizumab; MEDI-563

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.
    

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 (<=) 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.

        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.