Study to evaluate efficacy and safety of Benralizumab in reducing Oral Corticosteroid use in adult patients with severe asthma.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

1. Peripheral blood eosinophil count of =150 cells/µL assessed by central lab at Visit 1 or = 300 cells/µL in the past 12 months

2. History of physician diagnosed asthma requiring continuous treatment with high dose ICS (high-dose ICS is budesonide/formoterol HFA = 640/18 per day or equivalent, or authorized generics for these products) plus LABA for at least 6 months prior to Visit 1. The ICS and LABA can be contained within a combination product or given by separate inhalers. The ICS can also be given via nebulized soultion for inhalation

3. Chronic oral corticosteroid therapy equivalent to a daily dose of at least 5 mg of prednisone, for at least 3 continuous months directly preceding Visit 1.

4. Patient should be on a stable OCS dose for at least 4 weeks prior to Visit 1.

5. Non-smokers, current smokers or former smokers with a smoking history of <20 pack-years at Visit 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 480
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1. Clinically important pulmonary disease other than asthma or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts

2. Known history of allergy or reaction to the study drug formulation

3. History of anaphylaxis to any biologic therapy

4. A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with, or has failed to respond to, standard of care therapy

5. Asthma exacerbation requiring use of systemic corticosteroids, or an increase in maintenance dose of OCS, or acute upper/lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to Visit 2 (first benralizumab dose)

6. A history of known immunodeficiency disorder including a history of positive human immunodeficiency virus (HIV) test

7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level =3 times the upper limit of normal (ULN) confirmed at Visit 1.

8. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained

9. Coincident primary adrenal failure (Addison’s disease) or irreversible secondary hypoadrenalism due to another independent cause (e.g. pituitary tumour or its treatment)

10. Co-existent inflammatory conditions for which chronic OCS doses are part of their maintenance treatment such as Giant Cell Arteritis, Polymyalgia Rheumatica

11. Exclusion from genetic research may be for any of the exclusion criteria specified in the main study or allogeneic bone marrow transplant, Non-leukocyte depleted whole blood transfusion within 120 days of genetic sample collection
12. Any disorder, including, but not limited to, 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 study or the interpretation
- Impede the subject's ability to complete the entire duration of study
13. Any clinically significant abnormal findings in physical examination, medical history, vital signs, hematology, clinical chemistry, or urinalysis during the enrollment period, 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 the patient's ability to complete entire duration of the study.
14. History of cancer. Patients who have had basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix are eligible provided that the patient is in remission and curative therapy was completed at least 12 months prior to the date informed
consent was obtained.
- Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained
15. Any other (non-asthma related) disease flare-up or AE/SAE during the screening period that requires the temporary use of systemic corticosteroids, increase in maintenance OCS, or requires antibiotics or antiviral medication within 30 days prior to Visit 2 (first benralizumab dose). However, an extension of 3 months of the screening period is allowed to ens

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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