Table I.

Inclusion and exclusion criteria

Inclusion criteria 1.Participant and/or parent or legal guardian must be able to understand and provide informed consent and/or assent, as applicable 2.Male or female, aged 1 y to <56 y at screening 3. In the case of peanut allergy, the participant must meet all of the following criteria to minimize the chance that the he or she will develop natural tolerance to peanut over the course of the study a. Positive result of skin prick test to peanut (wheal ≥4 mm larger than the saline control) b. Positive peanut IgE level (≥6 kUA/L) at screening or within 3 mo of screening, as determined by ImmunoCap c. Positive blinded OFC to peanut during the screening DBPCFC, defined as experiencing dose-limiting symptoms at 1 dose of ≤100 mg of peanut protein 4. Allergy to ≥2 of the other 6 foods (milk, egg, wheat, cashew, hazelnut, and walnut), with allergy to milk and egg defined as the inability to tolerate both cooked and uncooked forms; each participant must meet all of the following criteria for ≥2 of the other 6 foods to minimize the chance that the participant will develop natural tolerance to ≥2 of the 6 other foods over the course of the study a. Milk, egg, or wheat i. Positive result of skin prick test to the study food (wheal ≥4 mm larger than the saline control) ii. Positive result of test for food specific–IgE level (≥6 kUA/L) at screening or within 3 mo of screening, as determined by ImmunoCap iii. Positive result of blinded OFC to food during the screening DBPCFC, defined as experiencing dose-limiting symptoms at 1 dose of ≤300 mg of food protein b. Cashew, hazelnut, or walnut i. Positive result of skin prick test to food (wheal ≥4 mm larger than that of the saline control) or positive food specific–IgE level (≥6 kUA/L) at screening or within 3 mo of screening, as determined by ImmunoCap ii. Positive result of blinded OFC to food during the screening DBPCFC, defined as experiencing dose-limiting symptoms at 1 dose of ≤300 mg of food protein 5.With body weight (as measured at screening) and total serum IgE level (as measured within 3 mo of screening) suitable for omalizumab dosing 6.If the participant is a female of child-bearing age, she must have a negative urine or serum pregnancy test 7.In the case of a woman with childbearing potential, she must agree to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods (barrier methods or oral, injected, or implanted hormonal methods of contraception or other forms of hormonal contraception with comparable efficacy) during the treatment period and for 60 d after the last dose of study drug 8.Participants must plan to remain in the study area of an OUtMATCH clinical research unit during the trial 9.Participants must be willing to be trained on the proper use of an epinephrine autoinjector and be willing to provide an epinephrine autoinjector for the duration of the study

Exclusion criteria 1.Inability or unwillingness of a participant and/or parent or 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 during the blinded OFC in response to placebo during the screening DBPCFC 4.Sensitivity or suspected or known allergy to any ingredients (including excipients) of the active or placebo OFC material, multiallergen OIT, or drugs related to omalizumab (eg, mAbs, polyclonal gamma globulin). Guidance for determination of sensitivity to excipients will be detailed in the manual of procedures 5.Poorly controlled atopic dermatitis at screening, per the principal investigator’s discretion 6. Poorly controlled or severe asthma and/or wheezing at screening, defined by ≥1 of the following criteria a. Criteria listed in the latest asthma control guidelines from to the Global Initiative for Asthma (see Appendix 3) b. History of ≥2 courses of systemic corticosteroids within 6 mo of screening or 1 course of systemic corticosteroids within 3 mo of screening to treat asthma and/or wheezing c. Prior intubation and/or mechanical ventilation for asthma and/or wheezing d. One hospitalization or emergency department visit for asthma and/or wheezing within 6 mo of screening e. FEV1 value < 80% of predicted or ratio of FEV1 value to forced vital capacity of <75%, with or without controller medications (only for participants who are aged ≥7 y and able to undergo spirometry) f. Daily inhaled corticosteroid dosing of >500 μg of fluticasone (or an equivalent inhaled corticosteroid based on the CoFar inhaled corticosteroid equivalency tables) 7.History of severe anaphylaxis in response to participant-specific foods that will be used in this study, defined as neurologic compromise or requiring intubation 8.Treatment with a burst of oral, intramuscular, or intravenous steroids for >2 d for an indication other than asthma and/or wheezing within 30 d of screening 9.Currently receiving oral, intramuscular, or intravenous corticosteroids; tricyclic antidepressants; or β-blockers (oral or topical) 10.Past or current eosinophilic gastrointestinal disease within 3 y of screening 11.Past or current cancer, or currently being investigated for possible cancer 12.Previous adverse reaction to omalizumab 13.History or current use of any immunotherapy for any of the foods being examined in this study (eg, OIT, sublingual immunotherapy, epicutaneous immunotherapy) within 6 mo of screening 14.Treatment with mAb therapy, such as omalizumab, dupilumab, benralizumab, mepolizumab, reslizumab, or other immunomodulatory therapy within 6 mo of screening 15.Currently in the “build-up phase” of inhalant allergen immunotherapy (ie, maintenance dosing has not yet been reached); individuals tolerating maintenance allergen immunotherapy can be enrolled 16.Inability to discontinue taking antihistamines for the minimum washout periods required for skin prick tests or OFCs 17.Current participation in another therapeutic or interventional clinical trial or participation within 90 d of screening 18.Use of investigational drugs within 24 wk of screening 19.Pregnant or breast-feeding, or intending to become pregnant during the study or within 60 d after the last dose of omalizumab or placebo for omalizumab 20.Has a first-degree relative already enrolled in the study 21.Past or current medical problems (eg, severe latex allergy); history of other chronic diseases (other than asthma and/or wheezing, atopic dermatitis, or rhinitis) requiring therapy (eg, heart disease, diabetes); findings from physical assessment, or abnormalities in clinical laboratory testing results that are not listed but in the opinion of the principal investigator, may pose additional risks resulting from participation in the study, interfere with the participant’s ability to comply with study requirements, or affect the quality or interpretation of the data obtained from the study