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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2200

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. Patients that enter this study as an adolescent (at Visit 1) will be reconsented
using the appropriate ICF at the study visit following their 18th birthday, prior
to any study procedures being performed.
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 the last dose of Invesigational Product (IP).
4. For WOCBP only: Have a negative urine pregnancy test prior to
administration of IP at Visit 1.
5. All male patients who are sexually active must agree to use a double
barrier method of contraception from the first dose of IP until 16 weeks
after their last dose.
Are the trial subjects under 18? yes
Number of subjects for this age range: 93
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2040
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 67

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. Patients with major protocol deviations in any of the predecessor
studies at the discretion of the Sponsor

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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