Clinical trial NCT01227278: A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI-563 in Subjects With Moderate-to-severe Chronic Obstructive Pulmonary Disease and Sputum Eosinophilia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Benralizumab
MEDI-563
Pulmonary Disease, Chronic Obstructive
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2010-10-25
Enrollment: 421
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

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.

Primary outcomes:
measure: Annualized Incidence Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
timeFrame: Day 1 up to 393
Secondary outcomes:
measure: Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 up to 561
measure: Number of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
timeFrame: Day 1 up to 393
measure: Percentage of Participants Hospitalized Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
timeFrame: Day 1 up to 393
measure: Annual Incidence Rate of Hospitalization Due to Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
timeFrame: Day 1 up to 393
measure: Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Domain Scores at Day 393
timeFrame: Baseline, Day 393
measure: Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score
timeFrame: Day 393
measure: Change From Baseline in Chronic Respiratory Questionnaire Self-Administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
timeFrame: Baseline, Day 393
measure: Percentage of Participants With a 0.5-Point Improvement in Chronic Respiratory Questionnaire Self-administered Standardized Format (CRQ-SAS) Domain Scores at Day 393
timeFrame: Day 393
measure: Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Scores at Day 393
timeFrame: Baseline, Day 393
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Marietta
country: United States
facility: Research Site
state: Georgia
city: Normal
country: United States
facility: Research Site
state: Illinois
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Greenville
country: United States
facility: Research Site
state: South Carolina
city: Boerne
country: United States
facility: Research Site
state: Texas
city: Tyler
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Saskatoon
country: Canada
facility: Research Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Research Site
city: Hellerup
country: Denmark
facility: Research Site
city: København NV
country: Denmark
facility: Research Site
city: Odense C
country: Denmark
facility: Research Site
city: Århus C
country: Denmark
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Gdańsk
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Lérida
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: MedImmune Ltd
name: Rene van der Merwe, MBChB
role: STUDY_DIRECTOR
References:
citation: Sridhar S, Liu H, Pham TH, Damera G, Newbold P. Modulation of blood inflammatory markers by benralizumab in patients with eosinophilic airway diseases. Respir Res. 2019 Jan 18;20(1):14. doi: 10.1186/s12931-018-0968-8.
citation: Brightling CE, Bleecker ER, Panettieri RA Jr, Bafadhel M, She D, Ward CK, Xu X, Birrell C, van der Merwe R. Benralizumab for chronic obstructive pulmonary disease and sputum eosinophilia: a randomised, double-blind, placebo-controlled, phase 2a study. Lancet Respir Med. 2014 Nov;2(11):891-901. doi: 10.1016/S2213-2600(14)70187-0. Epub 2014 Sep 7.