Can a shot help people with high IgE eat more foods safely?
NCT ID NCT06934200
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether omalizumab injections, given every two weeks for 24 weeks, can help people aged 1 to 55 with high IgE levels tolerate more of their trigger foods. Participants who respond may then try adding the food to their diet with extra injections. The goal is to see if this approach is safe and effective for those who don't qualify for standard dosing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- omalizumab injections
- What this could lead to
- If successful, this could offer a new treatment option for people with food allergies who have high IgE levels, potentially allowing them to safely eat small amounts of trigger foods.
- What could go wrong
- This is a small, early-phase trial with only 32 participants. The treatment may not work for everyone, and there is a risk of allergic reactions during food challenges.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins
RECRUITINGBaltimore, Maryland, 21287, United States
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