A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA

Completed · Phase 3

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT02258542

Run by

AstraZeneca

People needed

2133

Starts

2014-11-19

Expected to finish

2018-07-02

Last updated by the study team

2019-08-21

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Female and male patients who completed the double-blind treatment period in a predecessor study on benralizumab or matching placebo.
• 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).
• For WOCBP only: Have a negative urine pregnancy test prior to administration of Investigational Product (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, 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
• 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

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Scottsboro, Alabama, United States
• Research Site — Glendale, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Alhambra, California, United States
• Research Site — Bakersfield, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — Redondo Beach, California, United States
• Research Site — Roseville, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Jose, California, United States
• Research Site — Stockton, California, United States
• Research Site — Walnut Creek, California, United States
• Research Site — Westminster, California, United States
• Research Site — Woodland, California, United States
• Research Site — Colorado Springs, Colorado, United States
• Research Site — Denver, Colorado, United States
• Research Site — Wheat Ridge, Colorado, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Brandon, Florida, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Cutler Bay, Florida, United States
• Research Site — Doral, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Andalusia, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.