A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lyophilized and Aged Liquid Omalizumab in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
Overview
- Phase
- Phase 2
- Intervention
- omalizumab
- Conditions
- Allergic Asthma
- Sponsor
- Genentech, Inc.
- Enrollment
- 61
- Primary Endpoint
- Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This was a multicenter, randomized, double-blind, parallel-group, three-arm, placebo-controlled study designed to demonstrate the efficacy of two different formulations of omalizumab compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult subjects with mild allergic asthma.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed Informed Consent Form
- •Meet criteria for the diagnosis of allergic asthma
- •Be between the ages of 18 to 65 years
- •Have a normal chest X-ray within 2 years of screening
Exclusion Criteria
- •Need daily controller medication for asthma
- •History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin)
- •Have a documented medical history of anaphylaxis
- •Have lung disease other than mild allergic asthma
- •Have taken other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer
- •Are unable or unwilling to comply with study procedures and visits
- •Are pregnant or lactating
- •Have significant medical illness other than asthma, including malignancies, parasitic infections, immune system disorders, and thrombocytopenia
- •Have been treated with omalizumab within 12 months prior to screening
- •Currently smoke or have a history of smoking more than 10 pack-years
Arms & Interventions
1
Intervention: omalizumab
2
Intervention: omalizumab
3
Intervention: placebo
Outcomes
Primary Outcomes
Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)
Time Frame: From baseline to Week 16
The primary analysis included two tests: a test for superiority of the lyophilized formulation of omalizumab compared with placebo in the change of allergen concentration and a test for the superiority of the aged liquid omalizumab compared with placebo. The difference for the change in the allergen concentration between the lyophilized formulation of omalizumab and placebo, and between the aged liquid omalizumab and placebo were assessed by the exact Wilcoxon-Mann-Whitney test.
Secondary Outcomes
- Ratio of the Allergen Forced Expiratory Volume at One Second (FEV1) Two-point Slope at the Week 16 Allergen Challenge to the Allergen FEV1 Two-point Slope at the Baseline Allergen Challenge(From baseline to Week 16)