A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma
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ClinicalTrials.gov Identifier: NCT01703312 |
Recruitment Status
:
Completed
First Posted
: October 10, 2012
Last Update Posted
: April 20, 2016
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Condition or disease | Intervention/treatment | Phase |
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Allergic Asthma | Drug: QGE031 Drug: omalizumab Drug: placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 37 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Placebo- and Comparator-controlled Study Evaluating the Effect of Multiple Doses of QGE031 Compared to Omalizumab in Asthma Induced by Allergen Bronchial Provocation |
Study Start Date : | November 2012 |
Actual Primary Completion Date : | October 2013 |
Actual Study Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: QGE031
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.
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Drug: QGE031
Drug administered by subcutaneous injection
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Active Comparator: omalizumab
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.
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Drug: omalizumab
Drug administered by subcutaneous injection
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Placebo Comparator: placebo
During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses).
|
Drug: placebo
Drug administered by subcutaneous injection
|
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703312
Canada, Alberta | |
Novartis Investigative Site | |
Calgary, Alberta, Canada, T2N 4N1 | |
Novartis Investigative Site | |
Edmonton, Alberta, Canada, T6G 2B7 | |
Canada, Ontario | |
Novartis Investigative Site | |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Canada, Quebec | |
Novartis Investigative Site | |
Ste-Foy, Quebec, Canada, G1V 4G5 | |
Canada, Saskatchewan | |
Novartis Investigative Site | |
Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
Canada | |
Novartis Investigative Site | |
Vancouver, Canada | |
Sweden | |
Novartis Investigative Site | |
Stockholm, Sweden, S-171 76 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01703312 History of Changes |
Other Study ID Numbers: |
CQGE031B2203 |
First Posted: | October 10, 2012 Key Record Dates |
Last Update Posted: | April 20, 2016 |
Last Verified: | April 2016 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Allergies, asthma, IgE |
Additional relevant MeSH terms:
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Omalizumab Anti-Allergic Agents Anti-Asthmatic Agents Respiratory System Agents |