A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

MedImmune

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: Placebo; Biological: Benralizumab 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01227278

MI-CP196

2010-020127-52 (EudraCT Number)

Details and patient eligibility

About

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

Full description

To evaluate the effect of multiple subcutaneous (SC) doses of benralizumab (MEDI 563) on the rate of moderate-to-severe annualized incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with moderate-to-severe COPD who exhibit eosinophilia (greater than or equal to [>=] 3.0 percent [%] sputum eosinophilia in the previous 12 months or at Screening) in sputum compared to placebo.

Enrollment: 421 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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421 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

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).

Treatment:

Other: Placebo

Benralizumab 100 mg

Experimental group

Description:

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).

Treatment:

Biological: Benralizumab 100 mg