Efficacy and Safety Study of Benralizumab Added to Medium-dose Inhaled Corticosteroid Plus LABA in Patients With Uncontrolled Asthma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Benralizumab reduces the number of asthma exacerbations in patients who remain uncontrolled on medium doses of ICS-LABA.

Official Title
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A Multicentre, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase III Efficacy and Safety Study of Benralizumab (MEDI-563) Added to Medium-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma

Conditions
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Asthma

Intervention / Treatment
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* Biological: Benralizumab
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study specific procedures Female and male aged from 18 to 75 years, inclusively History of physician-diagnosed asthma requiring treatment with medium dose ICS (>250ug fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit 1 Documented treatment with medium-dose ICS (>250ug and ≤500ug fluticasone dry powder formulation equivalents total daily dose) and LABA for at least 3 month prior to Visit 1 Exclusion criteria: Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg- Strauss syndrome, hypereosinophilic syndrome) 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 Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period 4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry, or urinalysis during screening/run-in 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Benra 30 mg q.4 Weeks<br>Fixed 30 mg dose of benralizumab (every 4 weeks) | Biological: Benralizumab<br>* Benra 30 mg q.4 Weeks is a fixed 30 mg dose of benralizumab subcutaneously on study week 0 until study week 44 inclusive. Benra 30 mg - Placebo q.8 Weeks is a fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administrated at the 4 week interim visits to maintain blind). It is subcutaneously administered on study week 0 until study week 44 inclusive.<br>|
| Experimental: Benra 30 mg - Placebo q.8 Weeks<br>Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind). | Biological: Benralizumab<br>* Benra 30 mg q.4 Weeks is a fixed 30 mg dose of benralizumab subcutaneously on study week 0 until study week 44 inclusive. Benra 30 mg - Placebo q.8 Weeks is a fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administrated at the 4 week interim visits to maintain blind). It is subcutaneously administered on study week 0 until study week 44 inclusive.<br>|
| Placebo Comparator: Placebo<br>A (Dummy) injection | Biological: Placebo<br>* Placebo subcutaneously on study week 0 until study week 44 inclusive.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Exacerbations Over 48 Weeks Treatment | The number of asthma exacerbations over 48 weeks treatment will be counted | 48 weeks treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases