A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Allergic Asthma

Intervention / Treatment
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* Drug: QGE031
* Drug: omalizumab
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QGE031<br>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. | Drug: QGE031<br>* Drug administered by subcutaneous injection<br>|
| Active Comparator: omalizumab<br>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. | Drug: omalizumab<br>* Drug administered by subcutaneous injection<br>|
| Placebo Comparator: placebo<br>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<br>* Drug administered by subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Number of participants with adverse events or other safety concerns |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergies, asthma, IgE