A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist
MELTEMI
A Multicenter, Open-label, Safety Extension Study With Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)
1 other identifier
interventional
447
15 countries
178
Brief Summary
The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA, NCT02258542).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 asthma
Started Jun 2016
Longer than P75 for phase_3 asthma
178 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
June 7, 2016
CompletedFirst Posted
Study publicly available on registry
June 22, 2016
CompletedStudy Start
First participant enrolled
June 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2020
CompletedResults Posted
Study results publicly available
April 13, 2021
CompletedApril 13, 2021
March 1, 2021
4 years
June 7, 2016
February 12, 2021
March 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Change From Baseline in Basophils, Full Analysis Set
Change from baseline in hematologic lab parameter of Basophils.
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Leukocytes, Full Analysis Set
Change from baseline in hematologic lab parameter of Leukocytes.
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Lymphocytes, Full Analysis Set
Change from baseline in hematologic lab parameter of Lymphocytes.
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Neutrophils, Full Analysis Set
Change from baseline in hematologic lab parameter of Neutrophils.
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Monocytes, Full Analysis Set
Change from baseline in hematologic lab parameter of Monocytes.
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Platelets, Full Analysis Set
Change from baseline in hematologic lab parameter of Platelets.
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Hematocrit, Full Analysis Set
Change from baseline in hematologic lab parameter of Hematocrit.
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Erythrocytes, Full Analysis Set
Change from baseline in hematologic lab parameter of Erythrocytes.
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Hemoglobin, Full Analysis Set
Change from baseline in hematologic lab parameter of Hemoglobin.
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set
Change from baseline in chemistry test ALT.
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set
Change from baseline in chemistry test AST.
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Change From Baseline in Bilirubin, Full Analysis Set
Change from baseline in chemistry test Bilirubin.
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Secondary Outcomes (5)
Number of Participants With Asthma Exacerbations During Study Period
From week 0 to week 184 in study treatment period and through the follow up period (12 weeks from day of last dose). Number and percentage of participants with asthma exacerbation during this period is presented.
Number of Participants Who Had Health Care Encounter (ie, Hospitalization, Emergency Department Visits, Urgent Care Visits, and All Other Outpatient Visits Due to Asthma) During Study Period
From week 0 to week 184 in study treatment period and through the follow up period (12 weeks from day of last dose). Number and percentage of participants with health care encounters during this period is presented.
Change of Blood Eosinophils Count
From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.
Number of Participants With Anti-drug Antibodies (ADA) Responses During the Study
From week 0 to week 184 in study treatment period and plus 12 weeks follow up period
Duration of Exposure
From week 0 to week 184 in study treatment period
Study Arms (2)
Benralizumab Arm A
OTHERBenralizumab administered subcutaneously every 4 weeks
Benralizumab Arm B
OTHERBenralizumab administered subcutaneously every 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Informed consent for study participation must be obtained prior to any study related procedures being performed and according to international guidelines and/or applicable European Union guidelines.
- Female and male patients who have completed at least 16 and not more than 40 weeks in Study D3250C00021.
- Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after the last dose of Investigational Product (IP)
- For WOCBP only: Have a negative urine pregnancy test prior to administration of IP at Visit 1.
- All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose.
You may not qualify if:
- 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
- Influence the findings of the study or their interpretations
- Impede the patient's ability to complete the entire duration of study
- A helminth parasitic infection diagnosed during a predecessor study that has either required hospitalization, has not been treated, has been incompletely treated or has failed to respond to standard of care therapy
- Any clinically significant change in physical examination, vital signs, ECG, hematology, clinical chemistry, or urinalysis during the predecessor study 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 interfere with the patient's ability to complete the entire duration of the study
- Current malignancy or malignancy that developed during the predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded).
- Receipt of live attenuated vaccines within 30 days prior to initiation of treatment in this study, during the treatment period, and for 16 weeks (5 half-lives) after the last dose of the IP
- Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
- Planned major surgical procedures during the conduct of the study
- Previous participation in the present study
- Concurrent enrolment in another drug-related interventional clinical trial
- AstraZeneca staff involved in the planning and/or conduct of the study
- Employees of the study center or any other individuals involved with the conduct of the study or immediate family members of such individuals
- Patients with important protocol deviations in the predecessor study at the discretion of the Sponsor
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (178)
Research Site
Scottsboro, Alabama, 35768, United States
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Glendale, Arizona, 85306, United States
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Phoenix, Arizona, 85012, United States
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Bakersfield, California, 93301, United States
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Newport Beach, California, 92663, United States
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Redondo Beach, California, 90277, United States
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Roseville, California, 95661, United States
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Sacramento, California, 95825, United States
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San Jose, California, 95117, United States
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Stockton, California, 95204, United States
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Westminster, California, 92683, United States
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Woodland, California, 95695, United States
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Colorado Springs, Colorado, 80907, United States
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Denver, Colorado, 80206, United States
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Wheat Ridge, Colorado, 80033, United States
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New Haven, Connecticut, 06520, United States
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Clearwater, Florida, 33765, United States
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Doral, Florida, 33172, United States
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Hialeah, Florida, 33012, United States
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Miami, Florida, 33134, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33176, United States
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Orlando, Florida, 32819, United States
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Orlando, Florida, 32825, United States
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Winter Park, Florida, 32789, United States
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Iowa City, Iowa, 52242, United States
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Bangor, Maine, 04401, United States
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Quincy, Massachusetts, 02169, United States
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Farmington Hills, Michigan, 48334, United States
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Flint, Michigan, 48504, United States
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Traverse City, Michigan, 49686, United States
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New York, New York, 10016, United States
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The Bronx, New York, 10461, United States
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Durham, North Carolina, 27705, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45231, United States
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Middleburg Heights, Ohio, 44130, United States
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Oklahoma City, Oklahoma, 73103, United States
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Oklahoma City, Oklahoma, 73120, United States
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Jefferson Hills, Pennsylvania, 15025, United States
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Philadelphia, Pennsylvania, 19140, United States
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Hodges, South Carolina, 29653, United States
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Rapid City, South Dakota, 57702, United States
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Dallas, Texas, 75225, United States
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Dallas, Texas, 75235, United States
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Houston, Texas, 77058, United States
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Houston, Texas, 77081, United States
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Houston, Texas, 77083, United States
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McKinney, Texas, 75069, United States
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Abingdon, Virginia, 24210, United States
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Falls Church, Virginia, 22044, United States
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Madison, Wisconsin, 53792, United States
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Buenos Aires, C1414AIF, Argentina
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Ciudad de Buenos Aire, C1121 ABE, Argentina
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La Plata, B1902COS, Argentina
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Mendoza, 5500, Argentina
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Mendoza, M5500GIP, Argentina
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Frankston, 3199, Australia
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Nedlands, 6009, Australia
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Parkville, 3050, Australia
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Randwick, 2031, Australia
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Woolloongabba, 4102, Australia
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Pazardzhik, 4400, Bulgaria
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Pernik, 2300, Bulgaria
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Petrich, 2850, Bulgaria
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Rousse, 7002, Bulgaria
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Sliven, 8800, Bulgaria
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Vratsa, 3000, Bulgaria
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Calgary, Alberta, T2N 4Z6, Canada
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Sherwood Park, Alberta, T8L 0N2, Canada
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Vancouver, British Columbia, V5Z 1M9, Canada
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Hamilton, Ontario, L8N 4A6, Canada
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Ottawa, Ontario, K1G 6C6, Canada
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Montreal, Quebec, H2W 1T8, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, Quebec, G1G 3Y8, Canada
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Québec, Quebec, G1V 4G5, Canada
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Quillota, 2260000, Chile
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Talcahuano, 4270918, Chile
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Valparaíso, 2341131, Chile
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Karlovy Vary, 360 17, Czechia
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Pilsen, 304 60, Czechia
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Prague, 130 00, Czechia
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Rokycany, 337 22, Czechia
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Brest, 29609, France
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Dijon, 21079, France
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Le Kremlin-Bicêtre, 94275, France
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Le Mans, 72037, France
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Lyon, 69317, France
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Marseille, 13915, France
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Montpellier, 34295, France
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Paris, 75018, France
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Pringy, 74374, France
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Saint-Pierre, 97448, France
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Strasbourg, 67091, France
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Toulouse, 31059, France
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Aschaffenburg, 63739, Germany
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Bamberg, 96049, Germany
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Berlin, 10367, Germany
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Frankfurt, 60596, Germany
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Frankfurt am Main, 60389, Germany
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Geesthacht, 21502, Germany
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Großhansdorf, 20927, Germany
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Hamburg, 22299, Germany
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Hanover, D-30173, Germany
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Leipzig, 04103, Germany
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Leipzig, 04207, Germany
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Mainz, 55131, Germany
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Marburg, 30625, Germany
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Rüdersdorf, 15562, Germany
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Aleksandrów Łódzki, 95-070, Poland
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Bialystok, 15-430, Poland
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Bydgoszcz, 85-168, Poland
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Dobre Miasto, 11-040, Poland
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Gdansk, 80-214, Poland
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Gorzów Wlkp, 66-400, Poland
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Grodzisk Mazowiecki, 05-825, Poland
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Kościan, 64-000, Poland
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Krakow, 31-011, Poland
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Krakow, 31-033, Poland
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Lodz, 90-141, Poland
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Lodz, 91-103, Poland
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Lubin, 59-300, Poland
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Lublin, 20-552, Poland
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Ostrów Wielkopolski, 63-400, Poland
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Poznan, 60-685, Poland
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Poznan, 60-693, Poland
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Poznan, 60-823, Poland
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Proszowice, 32-100, Poland
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Ruda Śląska, 41-709, Poland
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Rzeszów, 35-205, Poland
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Skierniewice, 96-100, Poland
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Sosnowiec, 41-200, Poland
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Tarnów, 33-100, Poland
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Trzebnica, 55-100, Poland
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Warsaw, 01-138, Poland
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Warsaw, 01-868, Poland
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Wieluń, 98-300, Poland
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Wołomin, 05-200, Poland
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Wroclaw, 50-220, Poland
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Wroclaw, 51-162, Poland
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Wroclaw, 53-301, Poland
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Żnin, 88-400, Poland
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Nizhny Novgorod, 603126, Russia
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Saint Petersburg, 196247, Russia
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Saratov, 410053, Russia
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Smolensk, 214019, Russia
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Vladikavkaz, 362007, Russia
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Volgograd, 400001, Russia
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Volgograd, 400131, Russia
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Yekaterinburg, 620039, Russia
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Yekaterinburg, 620149, Russia
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Málaga, 29010, Spain
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Palma de Mallorca, 07010, Spain
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Sagunto(Valencia), 46520, Spain
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Salamanca, 37007, Spain
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Valencia, 46015, Spain
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Valencia, 46017, Spain
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Adana, 01330, Turkey (Türkiye)
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Ankara, 06230, Turkey (Türkiye)
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Bursa, 16059, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Dnipro, 49006, Ukraine
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Ivano-Frankivsk, 76018, Ukraine
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Kharkiv Region, 61022, Ukraine
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Kharkiv Region, 61035, Ukraine
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Kharkiv Region, 61039, Ukraine
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Kharkiv Region, 61058, Ukraine
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Kyiv, 03680, Ukraine
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Kyiv, 04201, Ukraine
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Lutsk, 4300, Ukraine
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Vinnytsia, 21029, Ukraine
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Birmingham, B9 5SS, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Chertsey, B9 5SS, United Kingdom
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Cottingham, HU16 5JQ, United Kingdom
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Nottingham, NG5 1PB, United Kingdom
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Stevenage, SG1 4AB, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
All participants in this study had to complete treatment in predecessor studies. Therefore selection bias may exist. Baseline is defined for this study's entry value, not the value prior to Benralizumab treatment. All participants have been treated with Benralizumab prior to this study's entry.
Results Point of Contact
- Title
- AstraZeneca Information Center
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2016
First Posted
June 22, 2016
Study Start
June 30, 2016
Primary Completion
June 18, 2020
Study Completion
June 18, 2020
Last Updated
April 13, 2021
Results First Posted
April 13, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.