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Study terminated due to sponsor decision
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benra 30 mg q.4 Weeks | Experimental | Fixed 30 mg dose of benralizumab (every 4 weeks) |
|
| Benra 30 mg - Placebo q.8 Weeks | Experimental | 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). |
|
| Placebo | Placebo Comparator | A (Dummy) injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benralizumab | Biological | 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. |
| 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 |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William W. Busse, MD | Allergy, Pulmonary and Critical Care Medicine, Clinical Science Center 600 Highland Ave, Madison, WI USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
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The study was stopped with 13 patients randomised
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| ID | Title | Description |
|---|---|---|
| FG000 | Benra 30 mg q.4 Weeks | Fixed 30 mg dose of benralizumab every 4 weeks. |
| FG001 | Benra 30 Mg-Placebo q.8 Weeks | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Biological | Placebo subcutaneously on study week 0 until study week 44 inclusive. |
|
| Glendale |
| Arizona |
| United States |
| Research Site | San Jose | California | United States |
| Research Site | Centennial | Colorado | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Pembroke Pines | Florida | United States |
| Research Site | Winter Park | Florida | United States |
| Research Site | Lawrenceville | Georgia | United States |
| Research Site | Savannah | Georgia | United States |
| Research Site | Bellevue | Nebraska | United States |
| Research Site | Las Vegas | Nevada | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Pittsburgh | Pennsylvania | United States |
| Research Site | Warwick | Rhode Island | United States |
| Research Site | Rock Hill | South Carolina | United States |
| Research Site | Arlington | Texas | United States |
| Research Site | Austin | Texas | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Sugarland | Texas | United States |
| Research Site | Buenos Aires | Argentina |
| Research Site | Ciudad de Buenos Aire | Argentina |
| Research Site | São Paulo | Brazil |
| Research Site | Rousse | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Varna | Bulgaria |
| Research Site | Hamburg | Germany |
| Research Site | Mainz | Germany |
| Research Site | Bydgoszcz | Poland |
| Research Site | Giżycko | Poland |
| Research Site | Lodz | Poland |
| Research Site | Lubin | Poland |
| Research Site | Ostrów Wielkopolski | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Żnin | Poland |
| Research Site | Chelyabinsk | Russia |
| Research Site | Izhevsk | Russia |
| Research Site | Kazan' | Russia |
| Research Site | Moscow | Russia |
| Research Site | Novosibirsk | Russia |
| Research Site | Pyatigorsk | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Ulyanovsk | Russia |
| Research Site | Vladikavkaz | Russia |
| Research Site | Yekaterinburg | Russia |
| FG002 | Placebo | A (Dummy) injection |
| COMPLETED |
|
| NOT COMPLETED |
|
The number of participants for analysis will be from the full analysis set. The full analysis set consists of all patients randomized and receiving any investigational product, irrespective of their protocol adherence and continued participation in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Benra 30 mg q.4 Weeks | Fixed 30 mg dose of benralizumab every 4 weeks. |
| BG001 | Benra 30 Mg-Placebo q.8 Weeks | 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). |
| BG002 | Placebo | A (Dummy) injection |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Asthma Exacerbations Over 48 Weeks Treatment | The number of asthma exacerbations over 48 weeks treatment will be counted | Patients from the full analysis set will be used. All patients randomized and receiving any investigational product will be included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Posted | Number | Number of events | 48 weeks treatment |
|
|
|
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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 30 mg q.4 Weeks | Fixed 30 mg dose of benralizumab every 4 weeks. | 0 | 3 | 0 | 3 | ||
| EG001 | Benra 30 Mg-Placebo q.8 Weeks | 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). | 0 | 5 | 0 | 5 | ||
| EG002 | Placebo | A (Dummy) injection | 0 | 5 | 1 | 5 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prolonged expiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven Fox | AZ-PPD | 441480716682 | steven.fox@ppdi.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
| D008173 | Lung Diseases, Obstructive |
| ID | Term |
|---|---|
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C571386 | benralizumab |
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| Male |
|