A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease
Intervention: Placebo; Benralizumab 100 mg
Intervention description: Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).; Benralizumab (MEDI-563) 100 mg injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Intervention MeSH terms: Benralizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 421.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Benralizumab; MEDI-563; Pulmonary Disease, Chronic Obstructive

Summary:

      To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary
      Disease (COPD) in Adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 40-85 years at the time of Screening

          -  Written informed consent obtained from the subject prior to performing any protocol
             related procedures

          -  Documented history of 1 or more Annualized Incidence Rate of Moderate or Severe Acute
             Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)

          -  Current smoker or ex-smoker with a tobacco history of greater than or equal to (>=) 10
             pack-years

          -  Adequate contraception from screening through end of trial

          -  Able to read and write.

        Exclusion Criteria:

          -  Any condition that, in the opinion of the investigator, would interfere with
             evaluation of the investigational product or interpretation of subject safety or study
             results

          -  Pregnant, breastfeeding, or lactating women

          -  Known history of allergy or reaction to any component of the investigational product
             formulation

          -  History of anaphylaxis to any other biologic therapy

          -  Donation or transfusion of blood, plasma or platelets within the past 3 months prior
             to Screening

          -  Other significant pulmonary disease which in the opinion of the investigator or
             medical monitor, might compromise the interpretation of the study

          -  Fever greater than (>) 37.0 degree Centigrade (98.6 degree Fahrenheit) at Screening

          -  Receipt of any novel investigational medicinal product within 3 months before the
             first dose of investigational product in this study and through the end of the study

          -  Seropositive for hepatitis A, hepatitis B surface antigen, hepatitis C, or human
             immunodeficiency virus 1or 2 (HIV-1 or HIV 2)

          -  History of alcohol or drug abuse within the past year that required treatment that the
             investigator felt or medical monitor felt would compromise the study data
             interpretation

          -  Past or current malignancy within the past 5 years except adequately treated
             non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma
             in situ treated with apparent success more than 1 year prior to Screening

          -  Subjects participating in, or scheduled for, an intensive COPD rehabilitation program
             (subjects who are in the maintenance phase of a rehabilitation program are eligible to
             take part)

          -  Current diagnosis of asthma according to Global Initiative for Asthma guidelines

          -  Previous treatment with MEDI-563.