Benralizumab Airway Remodeling Study in Severe Eosinophil... | NCT03953300

ID	Type	Description	Link
2018-003391-13	EudraCT Number

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Benralizumab	Experimental	Administrated subcutaneously (SC) every 4 weeks for the first 3 doses, then every 8 weeks	Biological: Benralizumab
Placebo	Placebo Comparator	Administrated subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Benralizumab	Biological	Benralizumab: 30 mg/mL solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies	The change in eosinophil numbers expressed as number/mm2 in submucosa as measured by major basic protein (MBP) staining in endobronchial biopsies	From baseline to Week 48 (Visit 10)
The change in airway wall area percentage as the overall median for airway generations 3 and 4 combined as measured by quantitative computed tomography (QCT) imaging	The change in airway wall area percentage as the overall median for airway generations 3 and 4 combined as measured by quantitative computed tomography (QCT) imaging	From baseline to Week 48 (Visit 10)

Secondary Outcomes

Measure	Description	Time Frame
The change in eosinophil numbers, expressed as number/mm2 in epithelium as measured by major basic protein (MBP) staining in endobronchial biopsies	The change in eosinophil numbers, expressed as number/mm2 in epithelium as measured by major basic protein (MBP) staining in endobronchial biopsies	From baseline to Week 48 (Visit 10)

Other Outcomes

Measure	Description	Time Frame
The number of Adverse events (AEs)/serious adverse events (SAEs).	To evaluate the safety and tolerability of benralizumab. The number of Adverse events (AEs)/serious adverse events (SAEs).	From baseline to Week 52 (Visit 11)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female aged 18 through 70 years.
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.
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.
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
Negative pregnancy test.
Asthma control questionnaire (ACQ-6) >1.5.
Fewer than 12 exacerbations within the 6 months prior to Visit 3.

Exclusion Criteria:

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
Use of chronic immunosuppressive medication or receipt of immunoglobulin (or blood products) within 30 days prior to the date informed consent is obtained.
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.
Currently pregnant, breastfeeding or lactating women.

Name	Affiliation	Role
Mario Castro, MD	University of Kansas School of Medicine 3901 Rainbow Blvd. Kansas City, KS 66160, USA	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Birmingham	Alabama	35209	United States
Research Site

IPD Sharing Statement Module

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases
D017681	Hypereosinophilic Syndrome
D004802	Eosinophilia
D007960	Leukocyte Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases