This study will evaluate the efficacy of QGE031 compared to omalizumab in patients with allergic asthma. Each treatment's effect in changing the concentration of inhaled allergen that is required to elicit a 15% fall in the forced expiratory volume in one second (FEV1) at 12 weeks compared to baseline will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
37
Drug administered by subcutaneous injection
Drug administered by subcutaneous injection
Drug administered by subcutaneous injection
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
Ste-Foy, Quebec, Canada
Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1)
Time frame: Baseline, 12 weeks
Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1) following treatment with placebo and various doses of QGE031
Time frame: Baseline, 12 weeks
QGE031 blood concentrations
Time frame: 24 weeks
Number of participants with adverse events or other safety concerns
Time frame: 24 weeks
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Novartis Investigative Site
Saskatoon, Saskatchewan, Canada
Novartis Investigative Site
Vancouver, Canada
Novartis Investigative Site
Stockholm, Sweden