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



Status:Completed
Conditions:Asthma, Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - 75
Updated:2/8/2019
Start Date:November 19, 2014
End Date:July 2, 2018

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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

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.

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 last dose of
Investigational Product (IP).

4. For WOCBP only: Have a negative urine pregnancy test prior to administration of
Investigational Product (IP) at Visit 1.

5. 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.

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. 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

6. Receipt of immunoglobulin or blood products within 30 days prior to Visit 1

7. Planned major surgical procedures during the conduct of the study

8. Previous participation in the present study

9. Concurrent enrolment in another clinical trial

10. AstraZeneca staff involved in the planning and/or conduct of the study

11. Employees of the study centre or any other individuals involved with the conduct of
the study or immediate family members of such individuals

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