A Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus LABA
Condition: Asthma
MeSH terms: Asthma
Intervention: Benralizumab; Benralizumab
Intervention description: Benralizumab administered subcutaneously; Benralizumab administered subcutaneously
Intervention MeSH terms: Benralizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2133.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases

Summary:

      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.
    

Eligibility criteria:

        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