Peanut Hypersensitivity
Conditions
Keywords
TOPS, Peanut allergy, Peanut-induced allergy, Allergy
Brief summary
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.
Interventions
DRUGomalizumab
Subcutaneous repeating dose
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Completion of last visit (or early termination visit, if applicable) for Study Q2788g * Signed Informed Consent Form * Use of an effective method of contraception for females of childbearing potential * Body weight ≥ 20 kg and ≤ 150 kg * IgE level ≤ 1300 IU/mL (Note: Subjects with an IgE \< 30 IU/mL will be dosed at the lowest level on the dosing table \[30 IU/mL\], thus enabling better understanding of the role of Xolair in peanut allergic subjects who have low total IgE levels.)
Exclusion criteria
* Withdrawal from Study Q2788g prior to study closure or the final study visit (Week 36) * Current participation in another investigational study * Pregnancy or lactation * History of brittle asthma * Aspirin-sensitive asthma * Known hypersensitivity to any ingredients of Xolair, including its excipients (sucrose, histidine, polysorbate 20) * Have a polymorrphonuclear count \<1500/uL * Use of anti-coagulants, such as warfarin (Coumadin(R)), thrombolytic enzymes, or ticlopidine * Current diagnosis of cancer, current investigation for possible cancer, or history of cancer (not including non-melanoma skin cancer) * Thrombocytopenia as evidenced by a platelet count \< 100,000/uL * Any systemic condition requiring regular administration of an immunoglobulin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | Through Week 52 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Food Allergen Exposure, Assessed on Patient-reported Questionnaire | Every 4 weeks through Week 52 | 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)." |
| Food-allergic Reactions As Assessed by the Ewan Scale | Through Week 52 | 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. |
| Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Through Week 52 | 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. |
Contacts
STUDY_DIRECTORDennis Wong, M.D.
Genentech, Inc.
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 4 |
| 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) | 7 |
| Total | 11 |
Baseline characteristics
| Characteristic | Omalizumab (Placebo in Q2788g) | Omalizumab (Omalizumab in Q2788g) | Total |
|---|---|---|---|
| Age, Continuous | 32.0 years STANDARD_DEVIATION 23.5 | 17.3 years STANDARD_DEVIATION 8.9 | 22.6 years STANDARD_DEVIATION 16.4 |
| Age, Customized >= 12 Years | 4 participants | 5 participants | 9 participants |
| Age, Customized 6 to < 12 Years | 0 participants | 2 participants | 2 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 3 / 4 | 6 / 7 |
| serious Total, serious adverse events | 0 / 4 | 1 / 7 |
Outcome results
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
Time frame: Through Week 52
Population: Safety-analysis population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab (Placebo in Q2788g) | Serious Adverse Events | Overdose | 0 participants |
| Omalizumab (Placebo in Q2788g) | Serious Adverse Events | Depression | 0 participants |
| Omalizumab (Omalizumab in Q2788g) | Serious Adverse Events | Overdose | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Serious Adverse Events | Depression | 1 participants |
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).
Time frame: Every 4 weeks through Week 52
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab (Placebo in Q2788g) | Food Allergen Exposure, Assessed on Patient-reported Questionnaire | Peanut | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Food Allergen Exposure, Assessed on Patient-reported Questionnaire | Peanut | 3 participants |
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). 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
Time frame: Through Week 52
Population: safety-evaluable population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab (Placebo in Q2788g) | Food-allergic Reactions As Assessed by the Ewan Scale | Grade 2 | 0 participants |
| Omalizumab (Placebo in Q2788g) | Food-allergic Reactions As Assessed by the Ewan Scale | Grade 4 | 0 participants |
| Omalizumab (Placebo in Q2788g) | Food-allergic Reactions As Assessed by the Ewan Scale | Grade 3 | 1 participants |
| Omalizumab (Placebo in Q2788g) | Food-allergic Reactions As Assessed by the Ewan Scale | Grade 5 | 0 participants |
| Omalizumab (Placebo in Q2788g) | Food-allergic Reactions As Assessed by the Ewan Scale | Grade 1 | 0 participants |
| Omalizumab (Omalizumab in Q2788g) | Food-allergic Reactions As Assessed by the Ewan Scale | Grade 5 | 0 participants |
| Omalizumab (Omalizumab in Q2788g) | Food-allergic Reactions As Assessed by the Ewan Scale | Grade 1 | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Food-allergic Reactions As Assessed by the Ewan Scale | Grade 2 | 0 participants |
| Omalizumab (Omalizumab in Q2788g) | Food-allergic Reactions As Assessed by the Ewan Scale | Grade 3 | 2 participants |
| Omalizumab (Omalizumab in Q2788g) | Food-allergic Reactions As Assessed by the Ewan Scale | Grade 4 | 0 participants |
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.
Time frame: Through Week 52
Population: safety-evaluable population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Lymphadenopathy | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Motion Sickness | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Tinnitus | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Diarrhoea | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Abdominal Pain | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Nausea | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Vomiting | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Lip Swelling | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Oral Pruritis | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Pyrexia | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Injection Site Bruising | 1 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Fatigue | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Nasopharyngitis | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Laryngitis | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Sinusitis | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Upper Respiratory Tract Infection | 1 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Pharyngitis Streptococcal | 1 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Gastroenteritis | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Otitis Media | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Localised Infection | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Anorexia | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Arthralgia | 1 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Loss of Consciousness | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Headache | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Migraine | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Dizziness | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Hypoaesthesia | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Menstruation Irregular | 1 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Cough | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Nasal Congestion | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Rhinitis Allergic | 1 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Asthma | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Pharyngolaryngeal Pain | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Rhinorrhoea | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Throat Irritation | 0 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Eczema | 1 participants |
| Omalizumab (Placebo in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Rash | 0 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Otitis Media | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Lymphadenopathy | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Pharyngolaryngeal Pain | 2 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Motion Sickness | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Localised Infection | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Tinnitus | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Cough | 3 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Diarrhoea | 2 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Anorexia | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Abdominal Pain | 2 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Rash | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Nausea | 2 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Arthralgia | 0 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Vomiting | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Nasal Congestion | 2 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Lip Swelling | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Loss of Consciousness | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Oral Pruritis | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Rhinorrhoea | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Pyrexia | 2 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Headache | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Injection Site Bruising | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Rhinitis Allergic | 0 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Fatigue | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Migraine | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Nasopharyngitis | 2 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Eczema | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Laryngitis | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Dizziness | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Sinusitis | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Asthma | 2 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Upper Respiratory Tract Infection | 0 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Hypoaesthesia | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Pharyngitis Streptococcal | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Throat Irritation | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Gastroenteritis | 1 participants |
| Omalizumab (Omalizumab in Q2788g) | Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs | Menstruation Irregular | 0 participants |