Trial Outcomes & Findings for A Randomized, Double-Blind, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis (NCT NCT00890162)
NCT ID: NCT00890162
Last Updated: 2019-07-01
Results Overview
To determine if treatment with omalizumab over 6 months will produce a reduction in the number and timing of anaphylactic events in subjects with a history of frequent idiopathic anaphylaxis. Ordinal outcome of participants based on number of events in 6 months after baseline and timing of first event. Events were calculated based on detailed event logs maintained by the patients and collected every 2-4 weeks based on injection schedule. Mean percent change in number of events experienced while on study agent for each subject and results presented as a group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
6 months
Results posted on
2019-07-01
Participant Flow
Participant milestones
| Measure |
Omalizumab
Subjects will receive two doses of Omalizumab while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
|
Placebo
Subjects will receive two doses of placebo while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
COMPLETED
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized, Double-Blind, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis
Baseline characteristics by cohort
| Measure |
Omalizumab
n=8 Participants
Subjects will receive two doses of Omalizumab while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
|
Placebo
n=8 Participants
Subjects will receive two doses of placebo while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTo determine if treatment with omalizumab over 6 months will produce a reduction in the number and timing of anaphylactic events in subjects with a history of frequent idiopathic anaphylaxis. Ordinal outcome of participants based on number of events in 6 months after baseline and timing of first event. Events were calculated based on detailed event logs maintained by the patients and collected every 2-4 weeks based on injection schedule. Mean percent change in number of events experienced while on study agent for each subject and results presented as a group.
Outcome measures
| Measure |
Omalizumab
n=8 Participants
Subjects will receive two doses of Omalizumab while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
|
Placebo
n=8 Participants
Subjects will receive two doses of placebo while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
|
|---|---|---|
|
Reduction in the Number and Timing of Anaphylactic Events in Subjects With a History of Frequent Idiopathic Anaphylaxis.
|
32 percentage of change of events
Interval 6.0 to 57.0
|
6 percentage of change of events
Interval -38.0 to 50.0
|
Adverse Events
Omalizumab
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Omalizumab
n=8 participants at risk
Subjects will receive two doses of Omalizumab while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
|
Placebo
n=8 participants at risk
Subjects will receive two doses of placebo while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal hernia
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Immune system disorders
Anaphylactic reaction
|
12.5%
1/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Immune system disorders
Hypersensitivity
|
25.0%
2/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
Other adverse events
| Measure |
Omalizumab
n=8 participants at risk
Subjects will receive two doses of Omalizumab while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
|
Placebo
n=8 participants at risk
Subjects will receive two doses of placebo while hospitalized, followed by continued outpatient therapy, every 2 to 4 weeks, for up to 6 months.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Cardiac disorders
Chest discomfort
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Cardiac disorders
Chest pain
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Cardiac disorders
Dizziness
|
12.5%
1/8 • 6 months
|
25.0%
2/8 • 6 months
|
|
Cardiac disorders
Dyspnoea
|
25.0%
2/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Cardiac disorders
Pulmonary congestion
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Cardiac disorders
Sinus bradycardia
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Cardiac disorders
Syncope
|
0.00%
0/8 • 6 months
|
25.0%
2/8 • 6 months
|
|
Cardiac disorders
Tachycardia
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Endocrine disorders
Hypoglycaemia
|
25.0%
2/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Endocrine disorders
Polydipsia
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Eye disorders
Conjunctivitis
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Eye disorders
Seasonal allergy
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
2/8 • 6 months
|
25.0%
2/8 • 6 months
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Gastrointestinal disorders
Oral candidiasis
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
25.0%
2/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
General disorders
Chills
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
General disorders
Flushing
|
25.0%
2/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
General disorders
Injection site pain
|
75.0%
6/8 • 6 months
|
75.0%
6/8 • 6 months
|
|
General disorders
Injection site pruritus
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
General disorders
Injection site reaction
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
General disorders
Pain
|
12.5%
1/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
General disorders
Pyrexia
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Hepatobiliary disorders
Hypoalbuminaemia
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Immune system disorders
Urticaria
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Infections and infestations
Infection
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Infections and infestations
Kidney infection
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • 6 months
|
25.0%
2/8 • 6 months
|
|
Injury, poisoning and procedural complications
Laceration
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Investigations
Blood creatinine increased
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Investigations
Haemoglobin decreased
|
12.5%
1/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Investigations
Weight decreased
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
2/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Nervous system disorders
Dysphonia
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • 6 months
|
37.5%
3/8 • 6 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Nervous system disorders
Personality change
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Psychiatric disorders
Mood altered
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
25.0%
2/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
2/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/8 • 6 months
|
12.5%
1/8 • 6 months
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • 6 months
|
0.00%
0/8 • 6 months
|
Additional Information
Carter, Melody
National Institute of Allergy and Infectious Diseases
Phone: +1 301 496 8772
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place