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This study will evaluate the safety, tolerability and efficacy of a single dose level of KB003 in subjects with inadequately controlled asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-GM-CSF Monoclonal Antibody 400mg | Experimental |
| |
| Normal Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-GM-CSF Monoclonal Antibody 400mg | Biological | Anti-GM-CSF Monoclonal Antibody 400mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent Predicted FEV1 at Week 24 | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate | Week 24 | |
| To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF) | Week 24 | |
| To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nestor A. Molfino, MD, MSc | KaloBios Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35216 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26739717 | Derived | Molfino NA, Kuna P, Leff JA, Oh CK, Singh D, Chernow M, Sutton B, Yarranton G. Phase 2, randomised placebo-controlled trial to evaluate the efficacy and safety of an anti-GM-CSF antibody (KB003) in patients with inadequately controlled asthma. BMJ Open. 2016 Jan 6;6(1):e007709. doi: 10.1136/bmjopen-2015-007709. |
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25 July 2012 - 09 June 2013
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| ID | Title | Description |
|---|---|---|
| FG000 | Anti-GM-CSF Monoclonal Antibody 400mg | Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg |
| FG001 | Normal Saline | Placebo: Normal Saline |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Other | Normal Saline |
|
| Week 24 |
| Fullerton |
| California |
| 92835 |
| United States |
| Granada Hills | California | 91344 | United States |
| Los Angeles | California | 90025 | United States |
| Rancho Mirage | California | 92270 | United States |
| Sacramento | California | 95819 | United States |
| San Jose | California | 95117 | United States |
| Centennial | Colorado | 80112 | United States |
| Colorado Springs | Colorado | 80907 | United States |
| Denver | Colorado | 80206 | United States |
| Waterbury | Connecticut | 06708 | United States |
| Miami | Florida | 33136 | United States |
| Miami | Florida | 33171 | United States |
| Tampa | Florida | 33613 | United States |
| Winter Park | Florida | 32789 | United States |
| Duluth | Georgia | 30096 | United States |
| Lawrenceville | Georgia | 30046 | United States |
| Savannah | Georgia | 31405 | United States |
| Lexington | Kentucky | 40536 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| St Louis | Missouri | 63110 | United States |
| Reno | Nevada | 89502 | United States |
| Summit | New Jersey | 07901 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Oklahoma City | Oklahoma | 73120 | United States |
| Oklahoma City | Oklahoma | 73131 | United States |
| Warwick | Rhode Island | 02886 | United States |
| Charleston | South Carolina | 29407 | United States |
| Charleston | South Carolina | 29425 | United States |
| Greenville | South Carolina | 29615 | United States |
| Arlington | Texas | 76012 | United States |
| Sugarland | Texas | 77479 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| Cairns | Queensland | 4870 | Australia |
| Woolonggabba | Queensland | 4102 | Australia |
| Bedford Park | South Australia | 5042 | Australia |
| Woodville | South Australia | 5011 | Australia |
| Box Hill | Victoria | 3128 | Australia |
| Frankston | Victoria | 3199 | Australia |
| Melbourne | Victoria | 3050 | Australia |
| Nedlands | Western Australia | 6009 | Australia |
| Marseille | 13015 | France |
| Montpellier | 34295 | France |
| Rennes | 35033 | France |
| Strasbourg | 67091 | France |
| Tours | 37044 | France |
| Bialystok | Podlaskie Voivodeship | 15-010 | Poland |
| Mrozy | Silesian Voivodeship | 05-321 | Poland |
| Wiłomin | Slaski | 05-200 | Poland |
| Biała Rawska | 96-230 | Poland |
| Bydgoszcz | 85-079 | Poland |
| Krakow | 31-033 | Poland |
| Krakow | 31-159 | Poland |
| Lodz | 90-153 | Poland |
| Lublin | 20-089 | Poland |
| Piasta | 15-044 | Poland |
| Dnipropetrovsk | 49074 | Ukraine |
| Donetsk | 83099 | Ukraine |
| Kharkiv | 61124 | Ukraine |
| Kyiv | 03680 | Ukraine |
| Odesa | 65009 | Ukraine |
| Simferopol | 95043 | Ukraine |
| Vinnytsia | 21029 | Ukraine |
| Yalta | 98600 | Ukraine |
| Zaporizhzhya | 69035 | Ukraine |
| Wishaw | Lanarkshire | ML2 0DP | United Kingdom |
| Northwood | Middlesex | HA6 2RN | United Kingdom |
| Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Leeds | West Yorkshire | LS9 7TF | United Kingdom |
| Southampton | SO16 6YD | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anti-GM-CSF Monoclonal Antibody 400mg | Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg |
| BG001 | Normal Saline | Placebo: Normal Saline |
| BG002 | 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 |
| |||||||||||||||
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Change in Percent Predicted FEV1 at Week 24 | Posted | Mean | Standard Deviation | Percent | Baseline to Week 24 |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | To Evaluate the Efficacy of KB003 as Measured by Asthma Exacerbation Rate | Not Posted | Week 24 | ||||||||||||||||||||||||||||||||||||
| Secondary | To Evaluate the Effect of KB003 on Peak Expiratory Flow (PEF) | Not Posted | Week 24 | ||||||||||||||||||||||||||||||||||||
| Secondary | To Evaluate the Safety and Tolerability of KB003 as Measured by Frequency and Severity of AEs, Clinical Safety, Laboratory Abnormalities and Chest Radiographic Assessments | Not Posted | Week 24 |
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Adverse Event Greater than or Equal to 5%
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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 | Anti-GM-CSF Monoclonal Antibody 400mg | Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg | 5 | 78 | 10 | 78 | ||
| EG001 | Normal Saline | Placebo: Normal Saline | 2 | 82 | 15 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders |
| |||
| Thrombosis in device | General disorders |
| |||
| Anaphylactic reaction | Immune system disorders |
| |||
| Pneumonia | Infections and infestations |
| |||
| Appendicitis | Infections and infestations |
| |||
| Arthritis bacterial | Infections and infestations |
| |||
| Suicide attempt | Psychiatric disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations |
| |||
| Upper respiratory tract infection | Infections and infestations |
| |||
| Headache | Nervous system disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nestor Molfino, MD | KaloBios Pharmaceuticals Inc. | 650-243-3100 | nmolfino@kalobios.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Poland |
|
| Ukraine |
|
| Australia |
|
| France |
|
| United Kingdom |
|