This is a randomized, double-blind, placebo controlled, four-arm, dose-ranging study. The purpose is to evaluate the relationship between the dose of lebrikizumab and the response in terms of the efficacy, safety, and tolerability in patients with asthma who are not on inhaled steroids.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
210
Subcutaneous repeating dose
Subcutaneous repeating dose
Subcutaneous repeating dose
Change in forced expiratory volume in 1 second (FEV1)
Time frame: Baseline to Week 12
Change in pre-bronchodilator FEV1
Time frame: Baseline to Week 24
Change in quality of life and symptom scores
Time frame: Baseline to Week 12
Change in peak flow
Time frame: Baseline to Week 1
Rate of asthma exacerbations
Time frame: During the 24-week treatment period
Change in rescue medication use
Time frame: From baseline to Week 1
Frequency and severity of adverse events
Time frame: From the first study-specific procedure through the last observation visit
Incidence of human anti-therapeutic antibodies (ATA)
Time frame: Baseline to Week 32
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Subcutaneous repeating dose