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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QGE031 | Experimental | During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses). Three dose levels of QGE031 will be offered during the study: low, medium, and high. Participants will be randomized to receive one of these dose levels for all dosing visits. |
|
| omalizumab | Active Comparator | During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses) or once every four weeks (total of three doses). The dose that a participant receives will depend upon the participant's body weight and IgE level; dosage will be determined based upon local omalizumab dosing charts. |
|
| placebo | Placebo Comparator | During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QGE031 | Drug | Drug administered by subcutaneous injection |
| |
| omalizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the concentration of inhaled allergen that elicits a 15% fall in the forced expiratory volume in one second (FEV1) | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 12 weeks | |
| QGE031 blood concentrations | 24 weeks |
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Inclusion Criteria:
Adult patients 18 to 65 years
Positive skin prick test to one or more common airborne allergens
Presence of airway hyperresponsiveness documented by a provocative concentration of methacholine causing a 20% fall in FEV1 (PC20 FEV1) of less than or equal to 16 mg/mL
Presence of an early asthmatic response demonstrated by an allergen challenge at screening and including a 15% fall in the FEV1
Patients with a body weight and total IgE in a range specified by local country prescribing information for omalizumab
Exclusion Criteria:
Pregnant or nursing (lactating) women
Women of child-bearing potential unless they are using a highly effective method of birth control (as further defined in the study protocol)
Smokers
Patients with poorly controlled asthma or patients who have had an asthma exacerbation within the past year
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Calgary | Alberta | T2N 4N1 | Canada | ||
| Novartis Investigative Site |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D001249 | Asthma |
| C562694 | Epilepsy, Idiopathic Generalized |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
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| ID | Term |
|---|---|
| C000598891 | ligelizumab |
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Drug |
Drug administered by subcutaneous injection |
|
| placebo | Drug | Drug administered by subcutaneous injection |
|
| Number of participants with adverse events or other safety concerns | 24 weeks |
| Edmonton |
| Alberta |
| T6G 2B7 |
| Canada |
| Novartis Investigative Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| Novartis Investigative Site | Ste-Foy | Quebec | G1V 4G5 | Canada |
| Novartis Investigative Site | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Novartis Investigative Site | Vancouver | Canada |
| Novartis Investigative Site | Stockholm | S-171 76 | Sweden |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |