This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of 3 dosing regimens of MEMP1972A in patients with allergic asthma who remain inadequately controlled on chronic therapy with high dose inhaled corticosteroids and a second controller medication.Patients will be randomized to 4 Arms to receive subcutaneous repeating dose of either MEMP1972A 150 mg, 300 mg, or 450 mg, or placebo. Patients will continue their usual asthma medication throughout the study. Anticipated time on study treatment is 36 weeks, with a 48-week follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
578
Subcutaneous repeating dose
Subcutaneous repeating dose
Subcutaneous repeating dose
Subcutaneous repeating dose
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Birmingham, Alabama, United States
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Bakersfield, California, United States
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Costa Mesa, California, United States
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Fountain Valley, California, United States
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Long Beach, California, United States
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Rate of protocol-defined asthma exacerbations (new or increased asthma symptoms that lead to treatment with systemic corticosteroids or to hospitalization) from baseline to Week 36
Time frame: 36 weeks
Relative change in pre-bronchodilator FEV1 (volume)
Time frame: from baseline to Week 12
Relative change in FEV1 (volume)
Time frame: from baseline to Week 36
Change in asthma symptoms
Time frame: from baseline to Week 12
Change in asthma symptoms
Time frame: from baseline to Week 36
Proportion of "well-controlled" weeks (no nighttime awakenings due to asthma symptoms and </= 2 days of SABA use per weeks, as documented by patient diary) from Week 24 to Week 36
Time frame: 12 weeks
Safety: Incidence of adverse events
Time frame: 48 weeks
Incidence of anti-therapeutic antibodies (ATAs)
Time frame: 84 weeks
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: Pre- and post-dose Weeks 0, 4, 12, 24 and 36
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Mission Viejo, California, United States
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Rancho Cordova, California, United States
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Redwood City, California, United States
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Stockton, California, United States
Unnamed facility
Torrance, California, United States
...and 135 more locations