Omalizumab to increase tolerance to common food allergens in people with high total IgE

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

This trial will test whether omalizumab injections every two weeks for 24 weeks, with an optional 8-week twice-weekly extension, can help people with food allergies and very high total IgE tolerate allergic foods.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 1 Year to 55 Years
• Sex: All
• Sponsor: Johns Hopkins University (Academic / other)
• Drugs / interventions: omalizumab, dupilumab, benralizumab, mepolizumab, reslizumab, tezepelumab, immunotherapy
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06934200 on ClinicalTrials.gov

What this trial studies

This Phase 2 trial enrolls people aged 1–55 with IgE‑mediated allergy to foods such as peanut, tree nuts, egg, milk, or wheat who have total IgE levels above current FDA-based dosing tables. Participants receive omalizumab injections every two weeks for 24 weeks; those who demonstrate increased tolerance may then undergo an 8-week twice-weekly injection period while reintroducing the food into the diet. Key entry requirements include a skin prick test wheal ≥6 mm, food-specific IgE ≥2.0 kUA/L, and a positive double-blind, placebo-controlled food challenge with a low cumulative threshold (≤144 mg; max tolerated ≤30 mg). The trial is led by Johns Hopkins with Genentech collaboration and is conducted at the Johns Hopkins site in Baltimore, Maryland.

Who should consider this trial

Good fit: Ideal candidates are ages 1–55 with confirmed IgE-mediated allergy to specified foods, elevated total IgE outside standard dosing tables, positive skin and specific IgE tests, and a qualifying low-threshold DBPCFC.

Not a fit: Patients with poorly controlled or severe asthma, a history of life‑threatening anaphylaxis to the study food, or significant abnormal screening labs are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could allow people with very high total IgE who are currently excluded from standard omalizumab dosing to increase tolerance to allergic foods and reduce reaction risk.

How similar studies have performed: Omalizumab has shown benefit in other allergic diseases and as an adjunct to oral immunotherapy, but using omalizumab alone in patients with very high total IgE is less well established.

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.

Where this trial is running

Baltimore, Maryland

• Johns Hopkins — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Robert Wood, MD — Johns Hopkins University
• Study coordinator: Robert Wood, MD

Conditions Food Hypersensitivity; omalizumab