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This is a Phase IIb, multicenter, open-label study available to active (Xolair) and control (placebo) subjects who have completed their final visit (or early termination visit, if applicable) for Study Q2788g, who meet the eligibility criteria of this study, and who provide consent to participate in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omalizumab | Drug | Subcutaneous repeating dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator | Through Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Food Allergen Exposure, Assessed on Patient-reported Questionnaire | Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: "Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify)" and "Did you have a reaction? (Yes/No)." | Every 4 weeks through Week 52 |
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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 | Omalizumab (Placebo in Q2788g) | Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table) |
| FG001 | Omalizumab (Omalizumab in Q2788g) | Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omalizumab (Placebo in Q2788g) | Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table) |
| BG001 | Omalizumab (Omalizumab in Q2788g) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Safety-analysis population |
| 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 | Serious Adverse Events | All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. An SAE is defined as an adverse event that results in death, is life threatening, requires hospitalization, results in significant disability, results in birth defect, or is considered a significant medical event by the investigator | Safety-analysis population | Posted | Number | participants | Through Week 52 |
|
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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 | Omalizumab (Placebo in Q2788g) | Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA (10.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications Specialist | Genentech, Inc. | 800-821-8590 |
| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System 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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| Food-allergic Reactions As Assessed by the Ewan Scale | The Ewan scale has five ascending grades of severity from "Grade 1" to "Grade 5" (as well, there is a possible value of "Not Applicable"). Grade 1 criteria: localized cutaneous erythema/urticaria/angioedema/oral pruritus. Grade 2 criteria: generalized erythema/urticaria/angioedema. Grade 3 criteria: Grade 1 or 2 events plus GI symptoms/rhinoconjunctivitis. Grade 4 criteria: mild laryngeal edema (voice change, tight throat) and/or mild asthma. Grade 5 criteria: pronounced dyspnea and/or hypotensive symptoms (light headedness/collapse/loss of consciousness). Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator. | Through Week 52 |
| Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs. | Through Week 52 |
Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
| BG002 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
|
|
| Secondary | Food Allergen Exposure, Assessed on Patient-reported Questionnaire | Participants were asked to record every 4 weeks in the food-related allergic event questionnaire: "Whether you were exposed to peanut, tree nut (cashew, almond, etc.), shellfish (shrimp, crab, etc.), eggs, milk, or other (please specify)" and "Did you have a reaction? (Yes/No)." | Posted | Number | participants | Every 4 weeks through Week 52 |
|
|
|
| Secondary | Food-allergic Reactions As Assessed by the Ewan Scale | The Ewan scale has five ascending grades of severity from "Grade 1" to "Grade 5" (as well, there is a possible value of "Not Applicable"). Grade 1 criteria: localized cutaneous erythema/urticaria/angioedema/oral pruritus. Grade 2 criteria: generalized erythema/urticaria/angioedema. Grade 3 criteria: Grade 1 or 2 events plus GI symptoms/rhinoconjunctivitis. Grade 4 criteria: mild laryngeal edema (voice change, tight throat) and/or mild asthma. Grade 5 criteria: pronounced dyspnea and/or hypotensive symptoms (light headedness/collapse/loss of consciousness). Following a report of an allergic reaction to food on a patient-reported questionnaire, the reaction is graded by the study coordinator or Principle Investigator. | safety-evaluable population | Posted | Number | participants | Through Week 52 |
|
|
|
| Secondary | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | All grades according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All AEs that do not meet any of the criteria for serious should be regarded as nonserious AEs. | safety-evaluable population | Posted | Number | participants | Through Week 52 |
|
|
|
| 0 |
| 4 |
| 3 |
| 4 |
| EG001 | Omalizumab (Omalizumab in Q2788g) | Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table) | 1 | 7 | 6 | 7 |
| Overdose | Injury, poisoning and procedural complications | MedDRA (10.0) |
|
| Anorexia | Metabolism and nutrition disorders |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Asthma | Respiratory, thoracic and mediastinal disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Diarrhoea | Gastrointestinal disorders |
|
| Dizziness | Nervous system disorders |
|
| Eczema | Skin and subcutaneous tissue disorders |
|
| Fatigue | General disorders |
|
| Gastroenteritis | Infections and infestations |
|
| Headache | Nervous system disorders |
|
| Hypoaesthesia | Nervous system disorders |
|
| Injection Site Bruising | General disorders |
|
| Laryngitis | General disorders |
|
| Lip Swelling | Gastrointestinal disorders |
|
| Localised Infection | Infections and infestations |
|
| Loss of Consciousness | Nervous system disorders |
|
| Lymphadenopathy | Blood and lymphatic system disorders |
|
| Menstruation Irregular | Reproductive system and breast disorders |
|
| Migraine | Nervous system disorders |
|
| Motion Sickness | Ear and labyrinth disorders |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders |
|
| Nasopharyngitis | Infections and infestations |
|
| Nausea | Gastrointestinal disorders |
|
| Oral Pruritis | Gastrointestinal disorders |
|
| Otitis Media | Infections and infestations |
|
| Pharyngitis Streptococcal | Infections and infestations |
|
| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders |
|
| Pyrexia | General disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders |
|
| Sinusitis | Infections and infestations |
|
| Throat Irritation | Respiratory, thoracic and mediastinal disorders |
|
| Tinnitus | Ear and labyrinth disorders |
|
| Upper Respiratory Tract Infection | Infections and infestations |
|
| Vomiting | Gastrointestinal 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.
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| Tinnitus |
|
| Diarrhoea |
|
| Abdominal Pain |
|
| Nausea |
|
| Vomiting |
|
| Lip Swelling |
|
| Oral Pruritis |
|
| Pyrexia |
|
| Injection Site Bruising |
|
| Fatigue |
|
| Nasopharyngitis |
|
| Laryngitis |
|
| Sinusitis |
|
| Upper Respiratory Tract Infection |
|
| Pharyngitis Streptococcal |
|
| Gastroenteritis |
|
| Otitis Media |
|
| Localised Infection |
|
| Anorexia |
|
| Arthralgia |
|
| Loss of Consciousness |
|
| Headache |
|
| Migraine |
|
| Dizziness |
|
| Hypoaesthesia |
|
| Menstruation Irregular |
|
| Cough |
|
| Nasal Congestion |
|
| Rhinitis Allergic |
|
| Asthma |
|
| Pharyngolaryngeal Pain |
|
| Rhinorrhoea |
|
| Throat Irritation |
|
| Eczema |
|
| Rash |
|