A MULTICENTRE, 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)
- Conditions
- -J45J45
- Registration Number
- PER-015-15
- Lead Sponsor
- ASTRAZENECA PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 54
Informed consent (and/or assent as applicable locally) 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.
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 a highly effective form of birth control throughout the study duration and for 16 weeks after the last dose of IP.
For WOCBP only: Have a negative urine pregnancy test prior to administration of
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.
Any disorder including but not limited to pulmonary, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, 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
Any clinically significant change in physical examination, vital signs, ECG, hematology, 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
Receipt of live attenuated vaccines within 30 days prior to initiation of treatment
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
Employees of the study centre or any other individuals involved with the conduct of the study or immediate family members of such individuals
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method