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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omalizumab | Drug | Aged Liquid; subcutaneous repeating dose |
| |
| omalizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1) | 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. | From baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity, measured in liters. The allergen FEV1 two-point slope is defined as the final percent change in FEV1 from pre-challenge value divided by the final value of allergen concentration used in the challenge. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Wong, M.D. | Genentech, Inc. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liquid Omalizumab | Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening |
| FG001 | Lyopholized Omalizumab | Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening |
| FG002 | Placebo | Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liquid Omalizumab | Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening |
| BG001 | Lyopholized Omalizumab | Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1) | 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. | Modified intent-to-treat (ITT) population | Posted | Median | Full Range | concentration change | From baseline to Week 16 |
|
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Safety evaluable population
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liquid Omalizumab | Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Discomfort | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Genentech, Inc. | 800-821-8590 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Drug |
Lyophilized; subcutaneous repeating dose |
|
| placebo | Drug | Subcutaneous repeating dose |
|
| From baseline to Week 16 |
| BG002 | Placebo | Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Lyopholized Omalizumab | Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening |
| OG002 | Placebo | Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening |
|
|
|
| Secondary | 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 | FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity, measured in liters. The allergen FEV1 two-point slope is defined as the final percent change in FEV1 from pre-challenge value divided by the final value of allergen concentration used in the challenge. | Modified ITT population | Posted | Median | Full Range | ratio of FEV1 | From baseline to Week 16 |
|
|
|
|
| 0 |
| 23 |
| 7 |
| 23 |
| EG001 | Lyopholized Omalizumab | Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening | 2 | 24 | 6 | 24 |
| EG002 | Placebo | Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening | 0 | 14 | 5 | 14 |
| Pyrexia | General disorders |
|
| Facial Pain | General disorders |
|
| Nasopharyngitis | Infections and infestations |
|
| Upper Respiratory Tract Infection | Infections and infestations |
|
| Joint Dislocation | Injury, poisoning and procedural complications |
|
| Concussion | Injury, poisoning and procedural complications |
|
| Contusion | Injury, poisoning and procedural complications |
|
| Joint Injury | Injury, poisoning and procedural complications |
|
| Headache | Nervous system disorders |
|
| Sinus Headache | Nervous system disorders |
|
| Middle Insomnia | Psychiatric disorders |
|
| Asthma | Respiratory, thoracic and mediastinal disorders |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
|
| Periorbital Oedema | Skin and subcutaneous tissue disorders |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| 0.0028 |
| 95 |
| Superiority or Other (legacy) |