Can a higher dose of xolair beat food allergies?
NCT ID NCT06943534
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if higher doses of omalizumab (Xolair) can help people with food allergies tolerate more of their trigger foods. Thirty participants with allergies to peanut, cashew, walnut, egg, or milk will receive either 5 mg/kg or 15 mg/kg of omalizumab for 16 weeks. The goal is to see if they can then eat at least 600 mg of the allergen without a reaction.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- omalizumab (Xolair)
- What this could lead to
- If successful, this could lead to a more effective dosing strategy for omalizumab, helping people with food allergies tolerate larger amounts of trigger foods without severe reactions.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. Higher doses may also increase side effects or fail to improve tolerance.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Apr 2028
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: * 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 * Clinically significant laboratory abnormalities at screening. * Sensitivity or suspected/known allergy to any ingredients (including excipients) of omalizumab. * 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, PICU admission f for continuous epinephrine for hypotension or severe respiratory compromise 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., OIT, SLIT, EPIT) within 6 months 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 for SPTs or 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
3 sites. 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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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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University of North Carolina at Chapel Hill
RECRUITINGChapel Hill, North Carolina, 27599, United States
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University of Texas Southwestern
RECRUITINGDallas, Texas, 75390, United States
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Other studies related to the condition(s) this trial covers.
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- Can allergy drugs help kids tolerate peanut and more?