Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients With Mild to Moderate Persistent Asthma
NCT ID: NCT02322775
Last Updated: 2017-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
211 participants
INTERVENTIONAL
2015-02-02
2015-10-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A
Benralizumab administered subcutaneously every 4 weeks
Benralizumab
Benralizumab administered subcutaneously every 4 weeks
Arm B
Placebo administered subcutaneously every 4 weeks
Placebo
Placebo administered subcutaneously every 4 weeks
Interventions
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Benralizumab
Benralizumab administered subcutaneously every 4 weeks
Placebo
Placebo administered subcutaneously every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Female and male aged 18 to 75 years, inclusively, at the time of Visit 1.
* Weight of ≥40 kg.
* Evidence of asthma as documented by post-bronchodilator (post-BD) reversibility in FEV1 of ≥ 12% demonstrated at Visit 2.
* Documented use of 1 of the following types of asthma therapy at time of informed consent: Low- to medium-dose ICS (ie, 100 to 500 μg fluticasone dry powder formulation equivalents total daily dose) with or without other controller medications, eg, an LTRA and/or theophylline or Low-dose ICS/LABA fixed combination therapy (eg, the lowest regular maintenance dose approved in the local country will meet this criterion)
* Morning pre-bronchodilator (pre-BD) FEV1 of \> 50% to ≤ 90% predicted at Visit 2.
Exclusion Criteria
* Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could:
* Affect the safety of the patient throughout the study
* nfluence the findings of the studies or their interpretations,- Impede the patient's ability to complete the entire duration of study.
* Known history of allergy or reaction to the investigational product formulation.
* History of anaphylaxis to any biologic therapy.- History of Guillain-Barré syndrome.
* A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to standard of care therapy.- Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period.
* Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening period, which in the opinion of the Investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete entire duration of the study.
* Positive hepatitis B surface antigen, or hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Patients with a history of hepatitis B vaccination without history of hepatitis B are allowed to enroll.
* A history of known immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test.
* History of cancer:
* Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed consent was obtained.
* Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained
18 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Gary T. Ferguson, M.D.,P.C.
Role: PRINCIPAL_INVESTIGATOR
Pulmonary Research Institute of Southeast Michigan
Locations
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Research Site
Los Angeles, California, United States
Research Site
Rolling Hills Estates, California, United States
Research Site
Clearwater, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Blue Island, Illinois, United States
Research Site
Skillman, New Jersey, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Monroe, North Carolina, United States
Research Site
Raleigh, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Grove City, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Medford, Oregon, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
El Paso, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Vancouver, British Columbia, Canada
Research Site
Ajax, Ontario, Canada
Research Site
Burlington, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Québec, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Saint-Charles-Borromée, Quebec, Canada
Research Site
Trois-Rivières, Quebec, Canada
Research Site
Bamberg, , Germany
Research Site
Berlin, , Germany
Research Site
Frankfurt, , Germany
Research Site
Frankfurt am Main, , Germany
Research Site
Hanover, , Germany
Research Site
Neu-Isenburg, , Germany
Research Site
Balassagyarmat, , Hungary
Research Site
Komárom, , Hungary
Research Site
Miskolc, , Hungary
Research Site
Pécs, , Hungary
Research Site
Pécs, , Hungary
Research Site
Százhalombatta, , Hungary
Research Site
Katowice, , Poland
Research Site
Mrągowo, , Poland
Research Site
Ostrów Wielkopolski, , Poland
Research Site
Pabianice, , Poland
Research Site
Poznan, , Poland
Research Site
Poznan, , Poland
Research Site
Tarnów, , Poland
Research Site
Wroclaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Bratislava, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Humenné, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Levice, , Slovakia
Research Site
Poprad, , Slovakia
Research Site
Prešov, , Slovakia
Research Site
Vráble, , Slovakia
Research Site
Žilina, , Slovakia
Countries
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References
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Ferguson GT, FitzGerald JM, Bleecker ER, Laviolette M, Bernstein D, LaForce C, Mansfield L, Barker P, Wu Y, Jison M, Goldman M; BISE Study Investigators. Benralizumab for patients with mild to moderate, persistent asthma (BISE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Respir Med. 2017 Jul;5(7):568-576. doi: 10.1016/S2213-2600(17)30190-X. Epub 2017 May 22.
Related Links
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Other Identifiers
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2014-004427-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D3250C00032
Identifier Type: -
Identifier Source: org_study_id
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