A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma
NCT ID: NCT01703312
Last Updated: 2016-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
37 participants
INTERVENTIONAL
2012-11-30
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
QGE031
Drug administered by subcutaneous injection
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.
omalizumab
Drug administered by subcutaneous injection
placebo
During the 10-week treatment period, participants will receive a dose of study drug subcutaneously once every two weeks (total of six doses).
placebo
Drug administered by subcutaneous injection
Interventions
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QGE031
Drug administered by subcutaneous injection
omalizumab
Drug administered by subcutaneous injection
placebo
Drug administered by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Novartis Investigative Site
Saskatoon, Saskatchewan, Canada
Novartis Investigative Site
Vancouver, , Canada
Novartis Investigative Site
Stockholm, , Sweden
Countries
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Other Identifiers
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CQGE031B2203
Identifier Type: -
Identifier Source: org_study_id
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