A Multicentre, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting β2 Agonist (BORA)
A Multicentre, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting β2 Agonist (BORA)
The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.
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 become unblinded to AstraZeneca for data analysis purposes. Study conduct and blinding at the site and patient level will remain unchanged.
Inclusion criteria
Exclusion criteria
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:
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
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
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).
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
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 clinical trial
AstraZeneca staff involved in the planning and/or conduct of the study
Employees of the study centre or any other individuals involved with the conduct of the study or immediate family members of such individuals
Patients with major protocol deviations in any of the predecessor studies at the discretion of the Sponsor
CABA, C1056ABJ, Argentina
CABA, C1425BEN, Argentina
CABA, C1431FWO, Argentina
Ciudad Autónoma de Bs. As., 1426, Argentina
Mainz Am Rhein, 55131, Germany
Asahi-shi, 289-2511, Japan
Chiyoda-ku, 102-0083, Japan
Itabashi-ku, 173-8610, Japan
Itabashi-ku, 174-0065, Japan
Kishiwada-shi, 596-8501, Japan
Kokubunji-shi, 185-0014, Japan
Mizunami-shi, 509-6134, Japan
Obihiro-shi, 080-0013, Japan
Ota-shi, 373-0807, Japan
Sagamihara-shi, 252-0315, Japan
Sakaide-shi, 762-8550, Japan
Setagaya-ku, 158-0097, Japan
Shibuya-ku, 150-0013, Japan
Shinagawa-ku, 142-8666, Japan
Sumida-ku, 130-8587, Japan
Toshima-ku, 170-0003, Japan
Tsukubo-gun, 701-0304, Japan
Gorzów Wlkp, 66-400, Poland
StPetersburg, 193312, Russia
Somerset, BS26 2BJ, United Kingdom