A Multi-center, Randomized, Placebo, Multi-Dose study to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
294
75 mg SC weekly injection
150 mg SC once weekly injection
300 mg weekly SC injection
The primary objective is to evaluate the efficacy of AMG 317 compared with placebo as measured by change in Asthma Control Questionnaire (ACQ) symptom scores from baseline to week 12.
Time frame: 12 weeks
Change from baseline in frequency of rescue beta agonist use during week 12
Time frame: 12 weeks
Change from baseline PEFR during week 12 (morning/evening, diurnal and inter-day variation)
Time frame: 12 weeks
Change in pre and post bronchodilator FEV1 at week 12 from baseline
Time frame: 12 weeks
Number of asthma symptom-free days
Time frame: 16 weeks
Change from baseline in daily asthma symptoms during week 12
Time frame: 12 weeks
Safety endpoints: number of asthma exacerbations, antibodies, adverse events, and change in ECG, labs and vital signs
Time frame: 16 weeks
Change in AQLQ score at week 12 from baseline
Time frame: 12 weeks
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Placebo SC once weekly injection