Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels

Launched by JOHNS HOPKINS UNIVERSITY · Apr 11, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the use of omalizumab, a medication given as an injection, to help people with food allergies. Specifically, the study is looking at whether 24 weeks (about 5 and a half months) of treatment can make it safer and easier for individuals to tolerate certain foods they are allergic to, like peanuts, eggs, or milk. Participants who show improvement in their ability to eat these foods after the initial treatment may continue with the injections for an additional 8 weeks to see if they can safely add the foods back into their diet.

To be eligible for this trial, participants need to be between 1 and 55 years old and must have a positive skin test indicating they are allergic to specific foods. They should also have a certain level of a protein called IgE that is often higher in people with allergies. Not everyone can join; for instance, those with severe asthma or a history of serious allergic reactions to the foods in the study are excluded. If eligible, participants can expect to receive injections every two weeks and will be carefully monitored for safety and effectiveness throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 1 to 55 years
• • A positive prick skin test (PST) with a wheal ≥ 6 mm to at least one of the relevant foods (peanut, cashew, walnut, egg, milk, or wheat)
• • Positive food-specific IgE (≥2.0 kilo units of allergen-specific IgE per liter (kUA/L)) to at least one of the study specific foods
• • A weight / IgE level that would have excluded the participant from the OUTMATCH study based on the dosing table noted above
• • Positive double-blind, placebo-controlled food challenge (DBPCFC) to one of the relevant foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg)
• Exclusion Criteria:
• • Clinically significant laboratory abnormalities at screening.
• • Dose-limiting symptoms during the blinded food challenge to placebo during the screening DBPCFC.
• • Poorly controlled or severe asthma/wheezing at screening
• • History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise or requiring intubation.
• • 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.
• • Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers.
• • Past or current history of eosinophilic gastrointestinal disease within three years of screening.
• • Past or current history of cancer, or currently being investigated for possible cancer.
• • Past or current history of any food immunotherapy (e.g., oral immunotherapy (OIT), sublingual immunotherapy (SLIT), epicutaneous immunotherapy (EPIT) within 6 months of screening.
• • Treatment with monoclonal antibody therapy, such as omalizumab, dupilumab, benralizumab, mepolizumab, reslizumab, tezepelumab, or other immunomodulatory therapy within 6 months of screening.
• • Inability to discontinue antihistamines for minimum wash-out periods required for skin prick tests (SPTs) or oral food challenges (OFCs).
• • Pregnant or breastfeeding, or intending to become pregnant during the study
• • Evidence of clinically significant chronic disease.