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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004205-24 | EudraCT Number |
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This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. The anticipated time on study treatment is up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study drug for all patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lebrikizumab - highest dose | Experimental |
| |
| lebrikizumab - lowest dose | Experimental |
| |
| lebrikizumab - middle dose | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lebrikizumab | Drug | subcutaneous dose every 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of asthma exacerbations during the 52-week placebo-controlled period | weeks 0-52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lung function: pre-bronchodilator FEV1 | from baseline to week 52 | |
| Time to first asthma exacerbation | from baseline to week 52 | |
| Change in fractional exhaled nitric oxide (FeNO) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford | Alabama | 36203-7190 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33217063 | Derived | Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7. | |
| 26001563 | Derived | Hanania NA, Noonan M, Corren J, Korenblat P, Zheng Y, Fischer SK, Cheu M, Putnam WS, Murray E, Scheerens H, Holweg CT, Maciuca R, Gray S, Doyle R, McClintock D, Olsson J, Matthews JG, Yen K. Lebrikizumab in moderate-to-severe asthma: pooled data from two randomised placebo-controlled studies. Thorax. 2015 Aug;70(8):748-56. doi: 10.1136/thoraxjnl-2014-206719. Epub 2015 May 22. |
| Label | URL |
|---|---|
| study website | View source |
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| lebrikizumab |
| Drug |
subcutaneous dose every 4 weeks |
|
| lebrikizumab | Drug | subcutaneous dose every 4 weeks |
|
| placebo | Drug | subcutaneous dose every 4 weeks |
|
| from baseline to week 52 |
| Change in asthma-specific health-related quality of life, assessed by the Standardized Asthma Quality of Life Questionnaire (AQLQ[S]) | from baseline to week 52 |
| Change in asthma rescue medication use | from baseline to week 52 |
| Rate of urgent asthma-related health care utilization during the 52-week placebo-controlled period | from baseline to week 52 |
| Long Beach |
| California |
| 90808 |
| United States |
| Los Angeles | California | 90025 | United States |
| Orange | California | 92868 | United States |
| Redwood City | California | 94063 | United States |
| San Mateo | California | 94401 | United States |
| Stockton | California | 95207 | United States |
| Centennial | Colorado | 80112 | United States |
| Colorado Springs | Colorado | 80907 | United States |
| Kissimmee | Florida | 34741 | United States |
| Miami | Florida | 33173 | United States |
| Panama City | Florida | 32405 | United States |
| Columbus | Georgia | 31904 | United States |
| Decatur | Georgia | 30033 | United States |
| Woodstock | Georgia | 30188 | United States |
| Twin Falls | Idaho | 83301 | United States |
| Normal | Illinois | 61761 | United States |
| Indianapolis | Indiana | 46208 | United States |
| Lafayette | Indiana | 47904 | United States |
| Overland Park | Kansas | 66210 | United States |
| Baltimore | Maryland | 21236 | United States |
| Brockton | Massachusetts | 02301 | United States |
| Bay City | Michigan | 48706 | United States |
| Novi | Michigan | 48375 | United States |
| Ypsilanti | Michigan | 48197 | United States |
| Minneapolis | Minnesota | 55402 | United States |
| Plymouth | Minnesota | 55441 | United States |
| Chesterfield | Missouri | 63017 | United States |
| St Louis | Missouri | 63141 | United States |
| Missoula | Montana | 59808 | United States |
| Omaha | Nebraska | 68130 | United States |
| Brick | New Jersey | 08724 | United States |
| Edison | New Jersey | 08820 | United States |
| Ocean City | New Jersey | 07712 | United States |
| Teaneck | New Jersey | 07666 | United States |
| Verona | New Jersey | 07044 | United States |
| North Syracuse | New York | 13212 | United States |
| Canton | Ohio | 44718 | United States |
| Centerville | Ohio | 45458 | United States |
| Cincinnati | Ohio | 45242 | United States |
| Toledo | Ohio | 43617 | United States |
| Oklahoma City | Oklahoma | 73120 | United States |
| Tulsa | Oklahoma | 74136 | United States |
| Medford | Oregon | 97504 | United States |
| Altoona | Pennsylvania | 16601 | United States |
| Hershey | Pennsylvania | 17033 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Pittsburgh | Pennsylvania | 15241 | United States |
| Pittsburgh | Pennsylvania | PA | United States |
| Sellersville | Pennsylvania | 18960 | United States |
| Columbia | South Carolina | 29201 | United States |
| Greenville | South Carolina | 29615 | United States |
| Austin | Texas | 78750 | United States |
| Austin | Texas | 78759 | United States |
| Boerne | Texas | 78006 | United States |
| El Paso | Texas | 79903 | United States |
| Houston | Texas | 77030 | United States |
| Sugar Land | Texas | 77479 | United States |
| Murray | Utah | 84107 | United States |
| Fairfax | Virginia | 22030 | United States |
| Spokane | Washington | 99204 | United States |
| Madison | Wisconsin | 53715 | United States |
| Brisbane | Queensland | 4075 | Australia |
| 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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| ID | Term |
|---|---|
| C561806 | lebrikizumab |
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