Trial Outcomes & Findings for A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g (NCT NCT00382148)
NCT ID: NCT00382148
Last Updated: 2009-12-15
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Through Week 52
Results posted on
2009-12-15
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
|
Overall Study
COMPLETED
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Xolair in Peanut-Allergic Subjects Previously Enrolled in Study Q2788g
Baseline characteristics by cohort
| Measure |
Omalizumab (Placebo in Q2788g)
n=4 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)
|
Omalizumab (Omalizumab in Q2788g)
n=7 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)
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
6 to < 12
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Age, Customized
>= 12
|
4 participants
n=93 Participants
|
5 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Age Continuous
|
32.0 years
STANDARD_DEVIATION 23.5 • n=93 Participants
|
17.3 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
22.6 years
STANDARD_DEVIATION 16.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Through Week 52Population: Safety-analysis population
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
Outcome measures
| Measure |
Omalizumab (Placebo in Q2788g)
n=4 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)
|
Omalizumab (Omalizumab in Q2788g)
n=7 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)
|
|---|---|---|
|
Serious Adverse Events
Depression
|
0 participants
|
1 participants
|
|
Serious Adverse Events
Overdose
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Every 4 weeks through Week 52Participants 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)."
Outcome measures
| Measure |
Omalizumab (Placebo in Q2788g)
n=4 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)
|
Omalizumab (Omalizumab in Q2788g)
n=7 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)
|
|---|---|---|
|
Food Allergen Exposure, Assessed on Patient-reported Questionnaire
Peanut
|
1 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Through Week 52Population: safety-evaluable population
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
Outcome measures
| Measure |
Omalizumab (Placebo in Q2788g)
n=4 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)
|
Omalizumab (Omalizumab in Q2788g)
n=7 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)
|
|---|---|---|
|
Food-allergic Reactions As Assessed by the Ewan Scale
Grade 5
|
0 participants
|
0 participants
|
|
Food-allergic Reactions As Assessed by the Ewan Scale
Grade 1
|
0 participants
|
1 participants
|
|
Food-allergic Reactions As Assessed by the Ewan Scale
Grade 2
|
0 participants
|
0 participants
|
|
Food-allergic Reactions As Assessed by the Ewan Scale
Grade 3
|
1 participants
|
2 participants
|
|
Food-allergic Reactions As Assessed by the Ewan Scale
Grade 4
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Through Week 52Population: safety-evaluable population
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.
Outcome measures
| Measure |
Omalizumab (Placebo in Q2788g)
n=4 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)
|
Omalizumab (Omalizumab in Q2788g)
n=7 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)
|
|---|---|---|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Vomiting
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Fatigue
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Nasopharyngitis
|
0 participants
|
2 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Lymphadenopathy
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Motion Sickness
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Tinnitus
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Anorexia
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Arthralgia
|
1 participants
|
0 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Loss of Consciousness
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Cough
|
0 participants
|
3 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Nasal Congestion
|
0 participants
|
2 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Rhinitis Allergic
|
1 participants
|
0 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Asthma
|
0 participants
|
2 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Throat Irritation
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Eczema
|
1 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Diarrhoea
|
0 participants
|
2 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Abdominal Pain
|
0 participants
|
2 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Nausea
|
0 participants
|
2 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Lip Swelling
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Oral Pruritis
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Pyrexia
|
0 participants
|
2 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Injection Site Bruising
|
1 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Laryngitis
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Sinusitis
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Upper Respiratory Tract Infection
|
1 participants
|
0 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Pharyngitis Streptococcal
|
1 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Gastroenteritis
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Otitis Media
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Localised Infection
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Headache
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Migraine
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Dizziness
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Hypoaesthesia
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Menstruation Irregular
|
1 participants
|
0 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Pharyngolaryngeal Pain
|
0 participants
|
2 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Rhinorrhoea
|
0 participants
|
1 participants
|
|
Nonserious Food-related Adverse Events (AEs) and Other Nonserious AEs
Rash
|
0 participants
|
1 participants
|
Adverse Events
Omalizumab (Placebo in Q2788g)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Omalizumab (Omalizumab in Q2788g)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omalizumab (Placebo in Q2788g)
n=4 participants at risk
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)
|
Omalizumab (Omalizumab in Q2788g)
n=7 participants at risk
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)
|
|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/4
|
14.3%
1/7
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/4
|
14.3%
1/7
|
Other adverse events
| Measure |
Omalizumab (Placebo in Q2788g)
n=4 participants at risk
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)
|
Omalizumab (Omalizumab in Q2788g)
n=7 participants at risk
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)
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/4
|
28.6%
2/7
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4
|
14.3%
1/7
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/4
|
28.6%
2/7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4
|
42.9%
3/7
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4
|
28.6%
2/7
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4
|
14.3%
1/7
|
|
Skin and subcutaneous tissue disorders
Eczema
|
25.0%
1/4
|
14.3%
1/7
|
|
General disorders
Fatigue
|
0.00%
0/4
|
14.3%
1/7
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4
|
14.3%
1/7
|
|
Nervous system disorders
Headache
|
0.00%
0/4
|
14.3%
1/7
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4
|
14.3%
1/7
|
|
General disorders
Injection Site Bruising
|
25.0%
1/4
|
14.3%
1/7
|
|
General disorders
Laryngitis
|
0.00%
0/4
|
14.3%
1/7
|
|
Gastrointestinal disorders
Lip Swelling
|
0.00%
0/4
|
14.3%
1/7
|
|
Infections and infestations
Localised Infection
|
0.00%
0/4
|
14.3%
1/7
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/4
|
14.3%
1/7
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4
|
14.3%
1/7
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
25.0%
1/4
|
0.00%
0/7
|
|
Nervous system disorders
Migraine
|
0.00%
0/4
|
14.3%
1/7
|
|
Ear and labyrinth disorders
Motion Sickness
|
0.00%
0/4
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/4
|
28.6%
2/7
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4
|
28.6%
2/7
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4
|
28.6%
2/7
|
|
Gastrointestinal disorders
Oral Pruritis
|
0.00%
0/4
|
14.3%
1/7
|
|
Infections and infestations
Otitis Media
|
0.00%
0/4
|
14.3%
1/7
|
|
Infections and infestations
Pharyngitis Streptococcal
|
25.0%
1/4
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/4
|
28.6%
2/7
|
|
General disorders
Pyrexia
|
0.00%
0/4
|
28.6%
2/7
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
25.0%
1/4
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4
|
14.3%
1/7
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.00%
0/4
|
14.3%
1/7
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4
|
14.3%
1/7
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
25.0%
1/4
|
0.00%
0/7
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4
|
14.3%
1/7
|
Additional Information
Medical Communications Specialist
Genentech, Inc.
Phone: 800-821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER