Omalizumab Weight-Based Dosing Efficacy Trial

Inclusion Criteria:

• A positive prick skin test (PST) with a wheal ≥ 6 mm to at least two of the relevantfoods (peanut, cashew, walnut, egg, or milk)

• Positive food specific IgE (≥2.0 kUA/L) to at least two of the relevant foods

• A positive history of clinical reaction to at least one of the qualifying foodsother than the challenge-qualifying food

(If meeting above criteria):

• Positive oral food challenge (OFC) to one of the potentially qualifying foods at acumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg)

Exclusion Criteria:

• Weight >80 kg at time of screening

• Clinically significant laboratory abnormalities at screening.

• Sensitivity or suspected/known allergy to any ingredients (including excipients) ofomalizumab.

• Poorly controlled or severe asthma/wheezing at screening

• History of severe anaphylaxis to participant-specific foods that will be used inthis study, defined as neurological compromise, PICU admission f for continuousepinephrine for hypotension or severe respiratory compromise requiring intubation.

• Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids ofmore than two days for an indication other than asthma/wheezing within 30 days ofscreening.

• Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers.

• Past or current history of eosinophilic gastrointestinal disease within three yearsof screening.

• Past or current history of cancer, or currently being investigated for possiblecancer.

• Past or current history of any food immunotherapy (e.g., OIT, SLIT, EPIT) within 6months of screening.

• Treatment with monoclonal antibody therapy, or other immunomodulatory therapy within 6 months of screening.

• Inability to discontinue antihistamines for minimum wash-out periods required forSPTs or OFCs.

• Pregnant or breastfeeding or intending to become pregnant during the study.

• Evidence of clinically significant chronic disease.