Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen OIT in Food Allergic Participants

Exclusion Criteria

• •1. Inability or unwillingness of a participant and/or parent/legal guardian to give written informed consent and/or assent or comply with the study protocol;
• •2. Clinically significant laboratory abnormalities at Screening;
• •3. Dose-limiting symptoms to the placebo portion of the Screening DBPCFC;
• •4. Sensitivity or suspected/known allergy to any ingredients (including excipients) of the
• •* active or placebo oral food challenge (OFC) material,
• •* multi-allergen oral immunotherapy (OIT), or
• •* drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin).
• •* Note: Guidance for determination of sensitivity to excipients will be detailed in the study's Manual of Procedures (MOP).
• •5. Poorly controlled atopic dermatitis (AD) at Screening, per the Principal Investigator's PI's) discretion;
• •6. Poorly controlled or severe asthma/wheezing at Screening, defined by at least one of the following criteria:
• •1. Global Initiative for Asthma (GINA) criteria regarding asthma control latest guidelines,
• •2. History of two or more systemic corticosteroid courses within six months of Screening or one course of systemic corticosteroids within three months of Screening to treat asthma/wheezing,
• •3. Prior intubation/mechanical ventilation for asthma/wheezing,
• •4. One hospitalization or Emergency Department (ED) visit for asthma/wheezing within six months of Screening,
• •5. Forced expiratory volume in one second (FEV1) \<80 percent of predicted or FEV1/forced vital capacity (FVC) \<75 percent, with or without controller medications (only for participants who are aged seven years or older and are able to perform spirometry), or
• •6. Inhaled corticosteroid (ICS) dosing of \>500 mcg daily fluticasone (or equivalent ICS based on the National Institutes of Health, National Heart, Lung, and Blood Institute (NHLBI) dosing chart).
• •7. History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise or requiring intubation;
• •8. Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing within 30 days of Screening;
• •9. Currently receiving oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or beta-blockers (oral or topical);
• •10. Past or current history of eosinophilic gastrointestinal (GI) disease within three years of Screening;
• •11. Past or current history of cancer, or currently being investigated for possible cancer;
• •12. Previous adverse reaction to omalizumab;
• •13. Past or current history of any immunotherapy to any of the foods being treated in this study (e.g., OIT, sublingual immunotherapy \[SLIT\], EPIT) within 6 months of Screening;
• •14. Treatment with monoclonal antibody therapy, such as omalizumab (Xolair®), dupilumab (Dupixent®), benralizumab (Fasenra™), mepolizumab (Nucala®), reslizumab (Cinqair®), or other immunomodulatory therapy within six months of Screening;
• •15. Currently on "build-up phase" of inhalant allergen immunotherapy (i.e., has not reached maintenance dosing). Note: Individuals tolerating maintenance allergen immunotherapy can be enrolled;
• •16. Inability to discontinue antihistamines for the minimum wash-out periods required for SPTs,or OFCs;
• •17. Current participation in another therapeutic or interventional clinical trial or participation within 90 days of Screening;
• •18. Use of investigational drugs within 24 weeks of Screening;
• •19. Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab or placebo for omalizumab;
• •20. Has a first-degree relative already enrolled in the study; or
• •21. Past or current medical problems (e.g., severe latex allergy), history of other chronic diseases (other than asthma/wheezing, AD, or rhinitis) requiring therapy (e.g., heart disease, diabetes), findings from physical assessment, or abnormalities in clinical laboratory testing that are not listed above, which, in the opinion of the PI, may:
• •* pose additional risks from participation in the study,
• •* may interfere with the participant's ability to comply with study requirements, or
• •* may impact the quality or interpretation of the data obtained from the study.