A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or
 severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult
 subjects with symptomatic, moderate to very severe COPD (Global Initiative for Chronic
 Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the
 underlying disease condition.
A Phase 2 double-blind, placebo-controlled study to evaluate the efficacy of MEDI8968 in
 Chronic Obstructive Pulmonary Disease. The study will have a screening phase of 23 days,
 treatment phase from Week 1 to 53 and follow-up phase from Week 53 to 69. Participants will
 receive either MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by
 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53 or matching placebo in the
 same fashion. Participants will primarily be assessed for incidence rate of moderate or
 severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Safety will be
 monitored throughout the study.
Inclusion Criteria:

 -  Age 45 through 75 years

 -  Predicted (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II,
 III, and IV) at Screening

 -  History of previous acute exacerbations of chronic obstructive pulmonary disease
 (AECOPD) 12 months prior to Screening

 -  Clinically stable and free from an AECOPD for 8 weeks prior to Day 1

 -  Current smoker or ex-smoker with a tobacco history of more than or equal to (>=) 10
 pack-years.

 Exclusion Criteria:

 -  Past or present disease or disorder,

 -  Significant or unstable ischemic heart disease etc

 -  Known history of allergy or reaction to any component of the investigational
 manufacturing product (IMP)

 -  Past or current malignancy within the past 5 years

 -  Subjects have had a chest x-ray or Computed Tomography (CT) scan suggestive of
 malignancy or tuberculosis (TB).

 -  Use of immunosuppressive medication receipt of any biologic agent.