Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics

Eligibility Criteria

• 1. Male or female aged 18 through 70 years.
• 2. Physician-diagnosed asthma requiring continuous treatment with medium- or high-dose ICS plus LABA with or without additional controller medication for at least 12 months prior to Visit 1, and current treatment with high-dose ICS plus LABA for at least 3 months prior to Visit 1 with or without additional asthma maintenance medication.
• 3. Morning pre-BD FEV1 ≥50 to \<80% of predicted normal value (PNV) and ≥1 liter (L) or morning pre-BD FEV1 ≥ 50 to \< 90% of PNV, if historical pre-BD FEV1 value (within 12 months prior to screening visit) was \< 80% of PNV.
• 4. A blood eosinophil count meeting any of 3 criteria: ≥300 cells/µL during screening or ≥ 220 to \< 300 cells/μL during screening and documented eosinophil count of ≥ 300 cells/μL in the past 12 months, or ≥150 to \<300 cells/µL during screening plus one of the following: presence of nasal polyps or pre-BD FVC \<65% predicted at Visit 2
• 5. Negative pregnancy test.
• 6. Asthma control questionnaire (ACQ-6) \>1.5.
• 7. Fewer than 12 exacerbations within the 6 months prior to Visit 3.
• 1. Any disease or concomitant medication which could affect study results or safety of study participants, including:
• * current smokers
• * history of cancer
• * life-threatening asthma
• * clinically important pulmonary disease other than asthma
• 2. Use of chronic immunosuppressive medication or receipt of immunoglobulin (or blood products) within 30 days prior to the date informed consent is obtained.
• 3. Previously received:
• * benralizumab
• * live attenuated vaccines 30 days prior to the date of randomization.
• * bronchial thermoplasty in the last 24 months prior to Visit 1
• * any investigational non-biologic within 30 days (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer.
• * any marketed or investigational biologic for the treatment of asthma within 4 months (or 5 half-lives) prior to the date informed consent is obtained, whichever is longer.
• 4. Currently pregnant, breastfeeding or lactating women.