A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA
Launched by ASTRAZENECA · Oct 3, 2014
Trial Information
Current as of May 21, 2025
Completed
Keywords
ClinConnect Summary
After a minimum of 1200 patients have been enrolled in this study, subsequent patients (up to a maximum of 2200 total for the study), who complete a minimum of 16 weeks, and no more than 40 weeks, in this study, will be given the option to transition to an open-label safety extension study, Study D3250C00037 (MELTEMI).
Adolescent patients, patients from Japan and South Korea, and any patient who chooses not to enter Study D3250C00037 will remain in this study through IPD or EOT and FU.
At the time of the first interim analysis in Japanese patients, the study regimen for all patients will ...
Gender
ALL
Eligibility criteria
- • Inclusion criteria
- • 1. Informed consent (and/or assent as applicable locally) for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent(s)/guardian(s)) and according to international guidelines and/or applicable European Union guidelines.
- • 2. Female and male patients who completed the double-blind treatment period in a predecessor study on benralizumab or matching placebo.
- • 3. Women of childbearing potential (WOCBP) must agree to use an effective form of birth control throughout the study duration and for 16 weeks after last dose of Investigational Product (IP).
- • 4. For WOCBP only: Have a negative urine pregnancy test prior to administration of Investigational Product (IP) at Visit 1.
- • 5. 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.
- • Exclusion criteria
- 1. Any disorder including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, 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 studies or their interpretations
- • Impede the patient's ability to complete the entire duration of study
- • 2. A helminth parasitic infection diagnosed during a predecessor study that has either not been treated, has been incompletely treated or has failed to respond to standard of care therapy
- • 3. Any clinically significant change in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during a 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
- • 4. Current malignancy or malignancy that developed during a 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).
- • 5. 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 investigational product
- • 6. Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
- • 7. Planned major surgical procedures during the conduct of the study
- • 8. Previous participation in the present study
- • 9. Concurrent enrolment in another clinical trial
- • 10. AstraZeneca staff involved in the planning and/or conduct of the study
- • 11. Employees of the study centre or any other individuals involved with the conduct of the study or immediate family members of such individuals
- • 12. Patients with major protocol deviations in any of the predecessor studies at the discretion of the Sponsor
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Sacramento, California, United States
Stockton, California, United States
Tulsa, Oklahoma, United States
Tampa, Florida, United States
Stara Zagora, , Bulgaria
Kazan, , Russian Federation
Madrid, , Spain
Oviedo, , Spain
Salamanca, , Spain
Göteborg, , Sweden
Denver, Colorado, United States
Wheat Ridge, Colorado, United States
Clearwater, Florida, United States
Normal, Illinois, United States
San Antonio, Texas, United States
Madison, Wisconsin, United States
Birmingham, Alabama, United States
Walnut Creek, California, United States
Colorado Springs, Colorado, United States
Louisville, Kentucky, United States
Cincinnati, Ohio, United States
Gainesville, Georgia, United States
New York, New York, United States
Salt Lake City, Utah, United States
Lubin, , Poland
Phoenix, Arizona, United States
Varna, , Bulgaria
Barcelona, , Spain
Iowa City, Iowa, United States
Montpellier, , France
Abingdon, Virginia, United States
Parkville, , Australia
Málaga, , Spain
Oklahoma City, Oklahoma, United States
Cottingham, , United Kingdom
Liverpool, , United Kingdom
Farmington Hills, Michigan, United States
Albuquerque, New Mexico, United States
Staten Island, New York, United States
Pittsburgh, Pennsylvania, United States
New Haven, Connecticut, United States
Redondo Beach, California, United States
Covington, Louisiana, United States
Bronx, New York, United States
Durham, North Carolina, United States
Philadelphia, Pennsylvania, United States
Mendoza, , Argentina
Pleven, , Bulgaria
Montreal, Quebec, Canada
Bradford, , United Kingdom
Glendale, Arizona, United States
Baltimore, Maryland, United States
Mckinney, Texas, United States
San Jose, California, United States
Greenfield, Wisconsin, United States
Milwaukee, Wisconsin, United States
Plzen, , Czechia
Bamberg, , Germany
Rüdersdorf, , Germany
Randwick, , Australia
Cambridge, , United Kingdom
Nottingham, , United Kingdom
Wilmington, North Carolina, United States
Szczecin, , Poland
Lund, , Sweden
Alhambra, California, United States
Hannover, , Germany
Concord, , Australia
Winter Park, Florida, United States
Glasgow, , United Kingdom
Warwick, Rhode Island, United States
Hialeah, Florida, United States
Roseville, California, United States
Gurnee, Illinois, United States
Box Hill, , Australia
Ruse, , Bulgaria
Teplice, , Czechia
Leipzig, , Germany
Vancouver, British Columbia, Canada
Burlington, Ontario, Canada
Grosshansdorf, , Germany
Quezon City, , Philippines
Uzhgorod, , Ukraine
Vinnytsia, , Ukraine
Frankfurt/Main, , Germany
Bucharest, , Romania
Brest Cedex, , France
Marseille, , France
Santiago, , Chile
Birmingham, , United Kingdom
Stevenage, , United Kingdom
Jindrichuv Hradec, , Czechia
Nizhny Novgorod, , Russian Federation
Sao Paulo, , Brazil
Calgary, Alberta, Canada
Scottsboro, Alabama, United States
Smolensk, , Russian Federation
Newport Beach, California, United States
Traverse City, Michigan, United States
Provo, Utah, United States
Suwon Si, , Korea, Republic Of
Iloilo City, , Philippines
Lipa City, , Philippines
Strasbourg Cedex, , France
Manchester, , United Kingdom
Plymouth, , United Kingdom
Portsmouth, , United Kingdom
Arlington, Texas, United States
Jefferson Hills, Pennsylvania, United States
San Miguel De Tucuman, , Argentina
Clayton, , Australia
Sliven, , Bulgaria
Aschaffenburg, , Germany
Grodzisk Mazowiecki, , Poland
Bangor, Maine, United States
Toulouse Cedex 09, , France
Moscow, , Russian Federation
Adana, , Turkey
Rapid City, South Dakota, United States
Boerne, Texas, United States
Quincy, Massachusetts, United States
Cusco, , Peru
Pringy Cedex, , France
Lawrenceville, Georgia, United States
Witten, , Germany
Valencia, , Spain
Izmir, , Turkey
Hamilton, Ontario, Canada
Berlin, , Germany
La Plata, , Argentina
Seoul, , Korea, Republic Of
Frankfurt Am Main, , Germany
Bakersfield, California, United States
Flint, Michigan, United States
Gwangju, , Korea, Republic Of
Dijon Cedex, , France
Bydgoszcz, , Poland
Dupnitsa, , Bulgaria
Yambol, , Bulgaria
Quebec, , Canada
Giżycko, , Poland
Katowice, , Poland
Skierniewice, , Poland
Chelyabinsk, , Russian Federation
Izhevsk, , Russian Federation
Novosibirsk, , Russian Federation
Saint Petersburg, , Russian Federation
Saratov, , Russian Federation
Hanoi, , Vietnam
Brandon, Florida, United States
Mar Del Plata, , Argentina
Samokov, , Bulgaria
Asahi Shi, , Japan
Itabashi Ku, , Japan
Sapporo Shi, , Japan
Tarnów, , Poland
Ekaterinburg, , Russian Federation
Vladikavkaz, , Russian Federation
Bursa, , Turkey
Ivano Frankivsk, , Ukraine
Ho Chi Minh, , Vietnam
Córdoba, , Argentina
Ostrava, , Czechia
Ruda Slaska, , Poland
Kyiv, , Ukraine
Bonn, , Germany
Nedlands, , Australia
Le Mans Cedex, , France
Ankara, , Turkey
Middleburg Heights, Ohio, United States
Hamburg, , Germany
Godoy Cruz, , Argentina
İstanbul, , Turkey
Westminster, California, United States
Doral, Florida, United States
Homestead, Florida, United States
Saint Louis, Missouri, United States
Winston Salem, North Carolina, United States
Hodges, South Carolina, United States
Dallas, Texas, United States
Houston, Texas, United States
St Charles Borromee, Quebec, Canada
Cutler Bay, Florida, United States
Ranelagh, , Argentina
Pazardzhik, , Bulgaria
Talcahuano, , Chile
Praha, , Czechia
Cheongju Si, , Korea, Republic Of
Kościan, , Poland
Rzeszów, , Poland
żnin, , Poland
Ryazan, , Russian Federation
Stpetersburg, , Russian Federation
Vladimir, , Russian Federation
Stanger, , South Africa
Shinagawa Ku, , Japan
Paris, , France
Mainz Am Rhein, , Germany
Palma De Mallorca, , Spain
Velingrad, , Bulgaria
Strakonice, , Czechia
Miami, Florida, United States
Fort Mitchell, Kentucky, United States
Petrich, , Bulgaria
Vratsa, , Bulgaria
Ottawa, Ontario, Canada
Valparaiso, , Chile
Karczew, , Poland
Koszalin, , Poland
Kraków, , Poland
Trzebnica, , Poland
Wroclaw, , Poland
łódź, , Poland
Istanbul, , Turkey
Dnipropetrovsk, , Ukraine
Yokohama Shi, , Japan
Busan, , Korea, Republic Of
Cape Town, , South Africa
Frankston, , Australia
Bedford Park, , Australia
Woolloongabba, , Australia
Andalusia, Alabama, United States
Orlando, Florida, United States
Mcallen, Texas, United States
Sherwood Park, Alberta, Canada
Karlovy Vary, , Czechia
Rokycany, , Czechia
Frankfurt, , Germany
Geesthacht, , Germany
Neu Isenburg, , Germany
Fukuoka Shi, , Japan
Kagoshima Shi, , Japan
Kishiwada Shi, , Japan
Kokubunji Shi, , Japan
Matsue Shi, , Japan
Mizunami Shi, , Japan
Niigata Shi, , Japan
Sakaide Shi, , Japan
Bucheon Si, , Korea, Republic Of
Dobre Miasto, , Poland
Lublin, , Poland
Proszowice, , Poland
Wrocław, , Poland
Bragadiru, , Romania
Constanta, , Romania
Deva, , Romania
Iasi, , Romania
Ivanovo, , Russian Federation
Pyatigorsk, , Russian Federation
Saint Petersburg, , Russian Federation
St.Petersburg, , Russian Federation
Tomsk, , Russian Federation
Volgograd, , Russian Federation
Chertsey, , United Kingdom
Santo Andre, , Brazil
Sorocaba, , Brazil
Quillota, , Chile
Incheon, , Korea, Republic Of
Saint Petersburg, , Russian Federation
Lutsk, , Ukraine
Union, New Jersey, United States
Caba, , Argentina
Concepción Del Uruguay, , Argentina
Corrientes, , Argentina
Nueve De Julio, , Argentina
Rosario, , Argentina
Pernik, , Bulgaria
Sofia, , Bulgaria
Białystok, , Poland
Gorzów Wlkp, , Poland
Ostrów Wielkopolski, , Poland
Sosnowiec, , Poland
Mersin, , Turkey
Chernivtsi, , Ukraine
Aleksandrów łódzki, , Poland
Albany, Georgia, United States
Herford, , Germany
Warszawa, , Poland
Wieluń, , Poland
Wołomin, , Poland
Northfield, New Jersey, United States
Hiroshima Shi, , Japan
Kobe Shi, , Japan
Shibuya Ku, , Japan
Sumida Ku, , Japan
Tsukubo Gun, , Japan
Durban, , South Africa
Mowbray, , South Africa
Ciudad Autónoma De Bs. As., , Argentina
Woodland, California, United States
Ocala, Florida, United States
Saint Paul, Minnesota, United States
Splendora, Texas, United States
Falls Church, Virginia, United States
Buenos Aires, , Argentina
Florida, , Argentina
New Lambton Heights, , Australia
Prahran, , Australia
Porto Alegre, , Brazil
São Paulo, , Brazil
Viña Del Mar, , Chile
Le Kremlin Bicêtre, , France
Lyon Cedex 4, , France
Pau Cedex, , France
Saint Pierre, , France
München, , Germany
Rostock, , Germany
Chiyoda Ku, , Japan
Chuo Ku, , Japan
Minato Ku, , Japan
Obihiro Shi, , Japan
Oita Shi, , Japan
Ota Shi, , Japan
Sagamihara Shi, , Japan
Sakai Shi, , Japan
Sendai Shi, , Japan
Setagaya Ku, , Japan
Takamatsu Shi, , Japan
Toshima Ku, , Japan
Anyang Si, , Korea, Republic Of
Jeju Si, , Korea, Republic Of
Lima, , Peru
Bielsko Biala, , Poland
Bystra śląska, , Poland
Gdańsk, , Poland
Poznań, , Poland
St. Petersburg, , Russian Federation
Yekaterinburg, , Russian Federation
Lugo, , Spain
Sagunto(valencia), , Spain
Kharkiv, , Ukraine
Chester, , United Kingdom
Darlington, , United Kingdom
Soham, , United Kingdom
Somerset, , United Kingdom
Stockton, , United Kingdom
Patients applied
Trial Officials
William W. Busse, M.D., Professor of Medicine
Principal Investigator
Allergy, Pulmonary, and Critical Care Medicine 600 Highland Avenue; Madison, WI
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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