Food Allergy, Peanut Allergy
Conditions
Keywords
Xolair, omalizumab, peanut, oral desensitization
Brief summary
The investigators will perform a double blind, placebo controlled clinical trial with Xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy. The investigators will determine if pretreatment with anti-IgE mAb (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer desensitization.
Detailed description
36 subjects will receive Xolair, and 8 subjects will receive placebo. The study will occur at 4 sites: Boston Children's Hospital, Children's Hospital of Philadelphia, Stanford University and Lurie Children's Hospital. Patients will be pre-treated with Xolair or placebo before rapid oral peanut desensitization. Patients will continue to receive Xolair during the 8 subsequent weeks of desensitization, receiving their final dose of Xolair one week after reaching the highest tolerated dose of peanut.
Interventions
DRUGOmalizumab
subcutaneous injection
DRUGplacebo
subcutaneous injection
Sponsors
Children's Hospital of Philadelphia
Stanford University
Ann & Robert H Lurie Children's Hospital of Chicago
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Moderate to severe peanut allergy-sensitive subjects between the ages of 7 to 25 years old. * Sensitivity to peanut allergen will be documented by a positive skin prick test result (6 mm diameter wheal or greater) * ImmunoCAP IgE level to peanut \> 10 kU/L. * Sensitivity to peanut allergen based on a double-blind placebo-controlled oral food challenge (DBPCFC) at maximum of cumulative 175 mg of peanut protein dose.
Exclusion criteria
* Subjects with a total IgE at screening of \< 50 kU/L \> 2,000 kU/L. * Positive reaction to the placebo on DBPCFC. * Previous reaction to omalizumab. * Subjects having a history of severe anaphylaxis to peanut requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma, or gastrointestinal or gastroesophageal disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo | 6 weeks after last dose of omalizumab/placebo |
Secondary
| Measure | Time frame |
|---|---|
| Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo | 12 weeks after last dose of omalizumab/placebo |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omalizumab Group Patients will receive omalizumab.
Omalizumab: subcutaneous injection | 29 |
| Placebo Patients will receive placebo.
placebo: subcutaneous injection | 8 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lack of Efficacy | 2 | 6 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Omalizumab Group | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 10 years | 10 years | 10 years |
| Baseline population | 29 Participants | 8 Participants | 37 Participants |
| Sex: Female, Male Female | 11 Participants | 4 Participants | 15 Participants |
| Sex: Female, Male Male | 18 Participants | 4 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 28 | 8 / 8 |
| serious Total, serious adverse events | 4 / 28 | 3 / 8 |
Outcome results
Primary
Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo
Time frame: 6 weeks after last dose of omalizumab/placebo
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Omalizumab Group | Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo | 23 Participants |
| Placebo | Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo | 1 Participants |
Secondary
Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo
Time frame: 12 weeks after last dose of omalizumab/placebo
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Omalizumab Group | Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo | 20 Participants |
| Placebo | Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo | 1 Participants |