1. Participants reacting objectively to the placebo during the screening DBPCFC. |
2. Severe asthma as defined by GINA 2019 [46] |
3. Active or past confirmed eosinophilic oesophagitis |
4. Participant currently under allergen immunotherapy |
5. Participant/parent with excessive anxiety unlikely to cope with study conditions as per investigator’s opinion |
6. Participant/parent unwillingness to comply with study requirements |
7. Participant unwillingness to ingest a daily food dose of up to 1500 mg of allergen protein |
8. Inability to discontinue anti-histamine medication prior to study procedures |
9. Known allergy to omalizumab or its excipients |
10. Known allergy to components of the placebo food treatment mix that cannot be substituted without interfering with the blind (i.e.: dates, banana, chocolate syrup) |
11. Use of immunosuppression or immunomodulatory drug (including omalizumab) or food oral immunotherapy or investigational treatment or procedure within 1 year |
12. Relative contraindication or inability to use epinephrine auto-injector |
13. Participants receiving beta-blockers or angiotensin converting-enzyme (ACE) inhibitors |
14. Pregnancy or lactation for the duration of the study |
15. Any condition that is not compatible with the study treatment or procedures as per investigator judgment |