Massachusetts General Hospital
This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.
This research is being conducted to assess the safety and effectiveness of omalizumab for food allergies dosed differently from what is currently FDA approved. The study hypothesizes the current way of dosing omalizumab may not work well for all patients with food allergy and it unnecessarily excludes some individuals with very high allergic antibody (IgE) who may benefit. This study will include subjects regardless of IgE level. One of the goals is to learn more about how safe and effective Omalizumab is for people with these high IgE levels, since this has not been fully studied before.
Inclusion Criteria: * A positive prick skin test (PST) with a wheal ≥ 6 mm to at least two of the relevant foods (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 foods other than the challenge-qualifying food (If meeting above criteria): * Positive oral food challenge (OFC) to one of the potentially qualifying foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg) Exclusion Criteria: * Weight \>80 kg at time of screening * Clinica…
5mg/kg of omalizumab
15mg/kg of omalizumab
Arctuva estimate
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