Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
NCT ID: NCT01238861
Last Updated: 2016-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
964 participants
INTERVENTIONAL
2010-12-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Eosinophilic phenotype (EOS+) Placebo
EOS+ (defined as ELEN Index \[proprietary mathematical algorithm to predict sputum eosinophil's greater than or equal to 2 percent\] positive and/or FeNO \[fraction of exhaled nitric oxide\] greater than or equal to \[\>=\] 50 parts per billion \[ppb\]) participants received matching placebo injections subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Placebo
EOS+ and EOS- participants received two placebo injections subcutaneously.
EOS+ Benralizumab (2 mg)
EOS+ participants received single benralizumab 2 milligram (mg) injection subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Benralizumab 2 mg
EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.
EOS+ Benralizumab (20 mg)
EOS+ participants received single benralizumab 20 mg injection subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Benralizumab 20 mg
EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.
EOS+ Benralizumab (100 mg)
EOS+ participants received benralizumab 50 mg as two injections subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Benralizumab 100 mg
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
Non-eosinophil phenotype (EOS-) Placebo
EOS- (defined as ELEN Index negative and FeNO \<50 ppb) participants received matching placebo subcutaneous every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Placebo
EOS+ and EOS- participants received two placebo injections subcutaneously.
EOS- Benralizumab (100 mg)
EOS- participants received benralizumab 50 mg as two injections subcutaneously every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
Benralizumab 100 mg
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
Interventions
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Benralizumab 2 mg
EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.
Benralizumab 20 mg
EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.
Benralizumab 100 mg
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
Placebo
EOS+ and EOS- participants received two placebo injections subcutaneously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adequate contraception from screening through end of trial
* Weight of more than (\>) 45 kilogram (kg) but less than or equal to (\<=) 150 kg (\>100 pound \[lb\] but \<=330 lb)
* History of physician-diagnosed asthma for at least 12 months prior to screening
* Physician prescribed daily use of medium-dose or high-dose inhaled corticosteroid(s) (ICS) plus long-acting beta 2 agonist (LABA) for at least 12 months prior to screening
* Willingness to switch to an ICS/LABA combination product
* Dose of other asthma controller medications must be stable for at least 30 days prior to screening
* At least 2 documented asthma exacerbations in the 12 months prior to screening that required use of a systemic corticosteroid burst
* For subjects 65 years of age or older, a chest x-ray (CXR) or chest computed tomography (CT) that is normal for an asthmatic population
* Ability and willingness to complete the study to Week 66, and if needed to Week 92.
Exclusion Criteria
* History of anaphylaxis to any biologic therapy
* Unexplained diarrhea within 30 days prior to screening or diagnosis of helminth parasitic infestation within 6 months prior to screening
* Use of immunosuppressive medication within 3 months prior to screening. Chronic oral prednisone or equivalent up to 10 milligram (mg) daily or 20 mg every other day for asthma is allowed
* Oral corticosteroid burst or short-acting systemic corticosteroid within 30 days prior to screening or during the screening/run-in period
* Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 30 days prior to the screening or during the screening/run-in period
* Receipt of immunoglobulin or blood products within 30 days prior to screening
* Receipt of any marketed or investigational biologic within 4 months or 5 half-lives prior to screening, whichever is longer
* Receipt of any investigational nonbiologic within 30 days or 5 half-lives prior to screening, whichever is longer
* Previously received MEDI-563
* Any clinically relevant abnormal findings in physical examination
* Past history of clinically significant cardiac disease or any electrocardiogram (ECG) abnormality
* Breastfeeding or lactating women
* History of alcohol or drug abuse within 12 months prior to screening
* History of any known primary immunodeficiency disorder
* Positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without history of hepatitis B are allowed to enrol
* A positive human immunodeficiency virus (HIV) test or subject taking antiretroviral medications
* History of cigarette smoking more than or equal to (\>=) 10 pack-years or smoking within 12 months prior to screening.
* Known exposure to inhaled occupational agents or fumes with an established diagnosis of occupational asthma
* History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy \>=12 months prior to screening or other malignancies treated with apparent success with curative therapy \>=5 years prior to screening
* Stable dose of allergy vaccination regimen for less than 30 days prior to screening
* Subjects unable to demonstrate acceptable inhaler and peak flow meter techniques.
18 Years
75 Years
ALL
No
Sponsors
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MedImmune Ltd
INDUSTRY
MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Donald Raible, MD
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Los Angeles, California, United States
Research Site
Orange, California, United States
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San Diego, California, United States
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Stockton, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Waterbury, Connecticut, United States
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Kissimmee, Florida, United States
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Tampa, Florida, United States
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Stockbridge, Georgia, United States
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Normal, Illinois, United States
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Baltimore, Maryland, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Bellevue, Nebraska, United States
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Summit, New Jersey, United States
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Rochester, New York, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Blue Bell, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Boerne, Texas, United States
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San Antonio, Texas, United States
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Seattle, Washington, United States
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Caba, , Argentina
Research Site
Ciudad de Buenos Aires, , Argentina
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San Miguel de Tucumán, , Argentina
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Santa Fe, , Argentina
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Curitiba, , Brazil
Research Site
Florianópolis, , Brazil
Research Site
Juiz de Fora, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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Salvador, , Brazil
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Santo André, , Brazil
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São Paulo, , Brazil
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Pleven, , Bulgaria
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Rousse, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Troyan Municipality, , Bulgaria
Research Site
Brampton, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
La Malbaie, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Bogotá, , Colombia
Research Site
Guadalajara, , Mexico
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México, , Mexico
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Monterrey, , Mexico
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Morelia, , Mexico
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Villahermosa, , Mexico
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Zapopan, , Mexico
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Lima, , Peru
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San Borja, , Peru
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San Isidro, , Peru
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Surco, , Peru
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Bialystok, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Lodz, , Poland
Research Site
Lublin, , Poland
Research Site
Ostrów Wielkopolski, , Poland
Research Site
Piła, , Poland
Research Site
Poznan, , Poland
Research Site
Tarnów, , Poland
Research Site
Warsaw, , Poland
Research Site
Barnaul, , Russia
Research Site
Chelyabinsk, , Russia
Research Site
Kazan', , Russia
Research Site
Moscow, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Yekaterinburg, , Russia
Countries
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References
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Castro M, Wenzel SE, Bleecker ER, Pizzichini E, Kuna P, Busse WW, Gossage DL, Ward CK, Wu Y, Wang B, Khatry DB, van der Merwe R, Kolbeck R, Molfino NA, Raible DG. Benralizumab, an anti-interleukin 5 receptor alpha monoclonal antibody, versus placebo for uncontrolled eosinophilic asthma: a phase 2b randomised dose-ranging study. Lancet Respir Med. 2014 Nov;2(11):879-890. doi: 10.1016/S2213-2600(14)70201-2. Epub 2014 Oct 8.
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.
Other Identifiers
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2010-020126-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MI-CP220
Identifier Type: -
Identifier Source: org_study_id