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: Not specified

Target Recruitment: 2133

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
re-consented 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

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

Study & Design

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