Benralizumab Efficacy in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) With Exacerbation History
NCT ID: NCT02138916
Last Updated: 2019-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1656 participants
INTERVENTIONAL
2014-06-13
2018-04-10
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
TRIPLE
Study Groups
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Benralizumab Arm A
Benralizumab administered subcutaneously
Benralizumab Arm A
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Benralizumab Arm B
Benralizumab administered subcutaneously
Benralizumab Arm B
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Placebo
Placebo administered subcutaneously
Placebo
Placebo subcutaneously on study week 0 until study week 48 inclusive
Interventions
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Benralizumab Arm A
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Benralizumab Arm B
Benralizumab subcutaneously on study week 0 until study week 48 inclusive
Placebo
Placebo subcutaneously on study week 0 until study week 48 inclusive
Eligibility Criteria
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Inclusion Criteria
3\. Unstable ischemic heart disease, arrhythmia, cardiomyopathy, or other relevant cardiovascular disorder that in Investigator's judgment may put the patient at risk or negatively affect the study outcome.
4\. Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to Visit1 or during the enrolment and run-in period.
5\. Acute upper or lower respiratory infection requiring antibiotics or antiviral medication within 2 weeks prior to Visit1or during the enrolment and run-in period.
6\. Pneumonia within 8 weeks prior to Visit1 or during the enrolment and run-in period.
7\. Pregnant, breastfeeding, or lactating women. 8. Risk factors for pneumonia 9. History of anaphylaxis to any other biologic therapy. 10. Long term oxygen therapy with signs and/or symptoms of cor pulmonale, right ventricular failure.
11\. Use of immunosuppressive medication within 2 weeks prior to Visit1 and/or during the enrolment and run-in period.
12\. Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1.
13\. Evidence of active tuberculosis (TB) without an appropriate course of treatment.
14\. Lung volume reduction surgery within the 6 months prior to Visit 1. History of partial or total lung resection (single lobe or segmentectomy is acceptable).
15\. Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
16\. Previous treatment with benralizumab. 17. Helminth parasitic infection diagnosed within 24 weeks prior to Visit 1.
40 Years
85 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Gerard Criner, MD
Role: PRINCIPAL_INVESTIGATOR
Temple University School of Medicine, 3401 North Broad Street, Suite 745 PP, Philadelphia, PA 19140
Locations
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Andalusia, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Little Rock, Arkansas, United States
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Lomita, California, United States
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Thousand Oaks, California, United States
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New Haven, Connecticut, United States
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Boynton Beach, Florida, United States
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Brandon, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Kissimmee, Florida, United States
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Loxahatchee Groves, Florida, United States
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Miami Springs, Florida, United States
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Eindhoven, , Netherlands
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Horn, , Netherlands
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Nijmegen, , Netherlands
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Zwolle, , Netherlands
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Bydgoszcz, , Poland
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Bragadiru, , Romania
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Constanța, , Romania
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Bloemfontein, , South Africa
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Gauteng, , South Africa
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Middelburg, , South Africa
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Wolverhampton, , United Kingdom
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References
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Criner GJ, Celli BR, Singh D, Agusti A, Papi A, Jison M, Makulova N, Shih VH, Brooks L, Barker P, Martin UJ, Newbold P. Predicting response to benralizumab in chronic obstructive pulmonary disease: analyses of GALATHEA and TERRANOVA studies. Lancet Respir Med. 2020 Feb;8(2):158-170. doi: 10.1016/S2213-2600(19)30338-8. Epub 2019 Sep 28.
Criner GJ, Celli BR, Brightling CE, Agusti A, Papi A, Singh D, Sin DD, Vogelmeier CF, Sciurba FC, Bafadhel M, Backer V, Kato M, Ramirez-Venegas A, Wei YF, Bjermer L, Shih VH, Jison M, O'Quinn S, Makulova N, Newbold P, Goldman M, Martin UJ; GALATHEA Study Investigators; TERRANOVA Study Investigators. Benralizumab for the Prevention of COPD Exacerbations. N Engl J Med. 2019 Sep 12;381(11):1023-1034. doi: 10.1056/NEJMoa1905248. Epub 2019 May 20.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Other Identifiers
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D3251C00003
Identifier Type: -
Identifier Source: org_study_id
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