This Phase III, randomized, double-blind, placebo-controlled, multicenter study will assess the efficacy and safety of lebrikizumab in adult patients with mild to moderate asthma treated with short-acting beta-agonist (SABA) therapy alone. Patients will be randomized in a 1:1:1 ratio to receive either blinded lebrikizumab or placebo treatment by subcutaneous (SC) injection (every 4 weeks for a total of 3 doses) or open-label treatment with Singulair (Montelukast; 10 mg daily). Time on study treatment will last 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
313
Given SC on Days 1, 29, and 57
10 mg given orally once daily for 12 weeks
SC injection given on Days 1, 29, and 57
Absolute change in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Time frame: From Baseline to Week 12
Relative change in morning pre-bronchodilator peak expiratory flow (PEF)
Time frame: From Baseline to Week 12
Time to treatment failure
Time frame: From Baseline to Week 12
Change in asthma rescue medication use
Time frame: From Baseline to Week 12
Incidence of adverse events
Time frame: Approximately 20 weeks
Pharmacodynamics: Relative change in fractional exhaled nitric oxide (FeNO)
Time frame: From Baseline to Week 12
Pharmacodynamics: Change in blood eosinophil count
Time frame: From Baseline to Week 12
Pharmacokinetics: Maximum serum lebrikizumab concentration after the first dose (Cmax)
Time frame: Week 1
Change in patient-reported outcome, as measured by the Standardized Asthma Quality of Life Questionnaire (AQLQ(S))
Time frame: From Baseline to Week 12
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Flagstaff, Arizona, United States
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Scottsdale, Arizona, United States
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Alhambra, California, United States
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Anaheim, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Napa, California, United States
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Rancho Mirage, California, United States
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Redwood City, California, United States
...and 102 more locations