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This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks on allergen-induced inflammation in subjects with mild atopic asthma challenged with an inhaled allergen.
This randomized, double-blind, parallel group, placebo-controlled study will evaluate the effect of a fixed 30 mg dose of benralizumab administered subcutaneously every 4 weeks for 3 doses on allergen-induced inflammation in subjects with mild atopic asthma challenged with an inhaled allergen.
Approximately 38 non-smoking men and women (18 - 65 years of age) corticosteroid-free (oral and inhaled) mild, atopic asthmatics who have demonstrated a dual (early and late) asthmatic response to inhaled allergen challenge at screening will be recruited to complete the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benralizumab | Experimental | Benralizumab administered subcutaneously |
|
| Placebo | Placebo Comparator | Placebo administered subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benralizumab | Biological | Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge | To evaluate the effect of benralizumab on allergen-induced increases in eosinophils in induced sputum | From prechallenge to 7 hours post allergen challenge during week 9 |
| Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge | To evaluate the effect of benralizumab on the allergen-induced late (3-7 hours post challenge) asthmatic response (LAR) | From prechallenge to 3 to 7 hours post allergen challenge during week 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Calgary | Alberta | T2N 4Z6 | Canada | ||
| Research Site |
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| Label | URL |
|---|---|
| The CSP redacted. | View source |
| The SAP redacted. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Benra 30mg q.4 Week | Benralizumab 30mg every 4 Weeks |
| FG001 | Placebo | Placebo every 4 Weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Benra 30mg q.4 Week | Benralizumab 30mg every 4 Weeks |
| BG001 | Placebo | Placebo every 4 Weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Percent of Eosinophils in Sputum 7 Hours Post Allergen Challenge | To evaluate the effect of benralizumab on allergen-induced increases in eosinophils in induced sputum | Primary Efficacy Analysis | Posted | Mean | Standard Deviation | Percent | From prechallenge to 7 hours post allergen challenge during week 9 |
|
From Visit 1a to Visit 17
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Benra 30mg q.4 Week | Benralizumab 30mg every 4 Weeks | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cyanosis | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
This allergen challenge study was conducted in a mild, atopic asthma patient population, distinct from the current approved severe eosinophilic asthma indication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Jison | AstraZeneca | 001-202-577-6213 | Maria.Jison@astrazeneca.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 26, 2018 | Oct 22, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2019 | Oct 22, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C571386 | benralizumab |
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| Placebo | Other | Placebo subcutaneously on study week 0 until study week 16 day 1 inclusive |
|
| Edmonton |
| Alberta |
| T6G 2B7 |
| Canada |
| Research Site | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Research Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| Research Site | Québec | Quebec | G1V 4G5 | Canada |
| Research Site | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Lost to Follow-up |
|
| BG002 |
| Total |
Total of all reporting groups |
| Years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Maximal Percentage Decrease in Forced Expiratory Volume in 1 Second 3-7 Hours Post Allergen Challenge | To evaluate the effect of benralizumab on the allergen-induced late (3-7 hours post challenge) asthmatic response (LAR) | Primary Efficacy Analysis | Posted | Mean | Standard Deviation | Percent | From prechallenge to 3 to 7 hours post allergen challenge during week 9 |
|
|
|
|
| 23 |
| 0 |
| 23 |
| 7 |
| 23 |
| EG001 | Placebo | Placebo every 4 Weeks | 0 | 23 | 0 | 23 | 14 | 23 |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Catheter site haematoma | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Biliary colic | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nonalcoholic fatty liver disease | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Gastrointestinal viral infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Post procedural discomfort | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |