Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
A Phase 2b, Dose-ranging Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
2 other identifiers
interventional
964
10 countries
74
Brief Summary
The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Dec 2010
Longer than P75 for phase_2 asthma
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2010
CompletedFirst Posted
Study publicly available on registry
November 11, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
November 17, 2016
CompletedNovember 17, 2016
September 1, 2016
2.2 years
November 9, 2010
May 31, 2016
September 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annual Asthma Exacerbation Rate (AER) for Eosinophilic Phenotype (EOS+) Participants
The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroids or increase of a stable systemic maintenance dose for a duration of at least 3 days as prescribed or administered by the investigator or healthcare provider; or 2) participant initiation of systemic corticosteroids (tablets, suspension or injection) for a duration of at least 3 days as outlined in the Asthma Action Plan provided to the participant by the investigator on Day 1.
Week 1 up to Week 52
Secondary Outcomes (16)
Dose Response in EOS+ Participants
Baseline up to Week 66
Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ss)
Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52
Dose-Normalized Minimum Observed Serum Trough Concentration for Benralizumab at Steady-State (Ctrough, ssD)
Pre-dose (0 hour), Post-dose on Day 1, 6, Week 4, 16, 24, 32, 40, and 52
Percentage of Participants With Anti-Drug Antibodies (ADA) to Benralizumab in Eosinophilic Phenotype (EOS+) Participants
Baseline up to Week 92
Change From Baseline in Asthma Control Questionnaire (6-items) (ACQ-6) Score at Week 52
Baseline up to Week 52
- +11 more secondary outcomes
Study Arms (6)
Eosinophilic phenotype (EOS+) Placebo
PLACEBO COMPARATOREOS+ (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.
EOS+ Benralizumab (2 mg)
EXPERIMENTALEOS+ 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.
EOS+ Benralizumab (20 mg)
EXPERIMENTALEOS+ 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.
EOS+ Benralizumab (100 mg)
EXPERIMENTALEOS+ 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.
Non-eosinophil phenotype (EOS-) Placebo
PLACEBO COMPARATOREOS- (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.
EOS- Benralizumab (100 mg)
EXPERIMENTALEOS- 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.
Interventions
EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.
EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.
EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
EOS+ and EOS- participants received two placebo injections subcutaneously.
Eligibility Criteria
You may qualify if:
- Age 18 through 75 years at the time of screening
- 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.
You may not qualify if:
- Known history of allergy or reaction to any component of the investigational product formulation
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
- MedImmune Ltdcollaborator
Study Sites (74)
Research Site
Birmingham, Alabama, United States
Research Site
Los Angeles, California, United States
Research Site
Orange, California, United States
Research Site
San Diego, California, United States
Research Site
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
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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
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Florianópolis, Brazil
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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
Research Site
Rousse, Bulgaria
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Sofia, Bulgaria
Research Site
Troyan Municipality, Bulgaria
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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
Research Site
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
Research Site
San Borja, Peru
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San Isidro, Peru
Research Site
Surco, Peru
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Bialystok, Poland
Research Site
Bydgoszcz, Poland
Research Site
Lodz, Poland
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Lublin, Poland
Research Site
Ostrów Wielkopolski, Poland
Research Site
Piła, Poland
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Poznan, Poland
Research Site
Tarnów, Poland
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Warsaw, Poland
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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
Related Publications (2)
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.
PMID: 25306557RESULTSridhar 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.
PMID: 30658649DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rene van der Merwe, MBChB, MFPM, Medical Officer
- Organization
- MedImmune, LLC
Study Officials
- STUDY DIRECTOR
Donald Raible, MD
MedImmune LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2010
First Posted
November 11, 2010
Study Start
December 1, 2010
Primary Completion
March 1, 2013
Study Completion
August 1, 2013
Last Updated
November 17, 2016
Results First Posted
November 17, 2016
Record last verified: 2016-09