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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
205
subcutaneous dose every 4 weeks
subcutaneous dose every 4 weeks
subcutaneous dose every 4 weeks
subcutaneous dose every 4 weeks
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Oxford, Alabama, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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Redwood City, California, United States
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Rate of asthma exacerbations during the 52-week placebo-controlled period
Time frame: weeks 0-52
Change in lung function: pre-bronchodilator FEV1
Time frame: from baseline to week 52
Time to first asthma exacerbation
Time frame: from baseline to week 52
Change in fractional exhaled nitric oxide (FeNO)
Time frame: 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])
Time frame: from baseline to week 52
Change in asthma rescue medication use
Time frame: from baseline to week 52
Rate of urgent asthma-related health care utilization during the 52-week placebo-controlled period
Time frame: from baseline to week 52
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San Mateo, California, United States
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Stockton, California, United States
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Centennial, Colorado, United States
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Colorado Springs, Colorado, United States
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Kissimmee, Florida, United States
...and 53 more locations