A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01227278
Last Updated: 2016-10-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
421 participants
INTERVENTIONAL
2010-11-30
2013-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History
NCT02138916
Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History
NCT02155660
Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of Frequent Exacerbations
NCT04053634
A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
NCT01448850
Immunological Basis for Benralizumab Activity in Chronic Obstructive Pulmonary Disease (COPD)
NCT05273359
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
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).
Placebo
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 100 mg
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).
Benralizumab 100 mg
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
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 100 mg
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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
40 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
MedImmune LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Rene van der Merwe, MBChB
Role: STUDY_DIRECTOR
MedImmune Ltd
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Los Angeles, California, United States
Research Site
Marietta, Georgia, United States
Research Site
Normal, Illinois, United States
Research Site
Brooklyn, New York, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Greenville, South Carolina, United States
Research Site
Boerne, Texas, United States
Research Site
Tyler, Texas, United States
Research Site
Richmond, Virginia, United States
Research Site
Calgary, Alberta, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Saskatoon, Saskatchewan, Canada
Research Site
Århus C, , Denmark
Research Site
Hellerup, , Denmark
Research Site
København NV, , Denmark
Research Site
Odense C, , Denmark
Research Site
Frankfurt, , Germany
Research Site
Mainz, , Germany
Research Site
Gdansk, , Poland
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Warsaw, , Poland
Research Site
Barcelona, , Spain
Research Site
Lleida, , Spain
Research Site
Málaga, , Spain
Research Site
Oviedo, , Spain
Research Site
Cambridge, , United Kingdom
Research Site
Edinburgh, , United Kingdom
Research Site
Leicester, , United Kingdom
Research Site
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-020127-52
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MI-CP196
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.