Can allergy drugs help kids tolerate peanut and more?
NCT ID NCT03679676
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding the drugs omalizumab (Xolair) or dupilumab (Dupixent) to oral immunotherapy (OIT) helps people with multiple food allergies tolerate more allergens. 130 participants aged 4 to 55 with allergies to peanut plus one or two other foods were enrolled. The goal was to see if these biologics improve the success of passing a food challenge to peanut and other allergens.
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) and dupilumab (Dupixent)
- What this could lead to
- If successful, this could lead to a safer and more effective way to treat multiple food allergies at once, reducing the risk of severe allergic reactions.
- What could go wrong
- This is a Phase 2 trial with a moderate number of participants, so results may not apply to everyone. The biologics can have side effects, and the treatment may not work for all allergens.
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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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130 people
The number who actually took part.
- Started
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Feb 2020
- Finished
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May 2025
- 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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4 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 4 through 55 years (inclusive). * Clinical history of peanut allergy and 1 or 2 additional foods from the following foods: milk, almond, shellfish, fish, cashew, hazelnut, egg, walnut, sesame seeds, soy, and wheat. Allergy to milk and egg is defined as unable to tolerate both cooked and uncooked forms. * Positive allergy test determined by: * ImmunoCAP serum IgE level \>4 kilo Units of allergen per Liter (kUA/L) for each allergen within the past 12 months OR * Skin prick test (SPT) ≥6 mm wheal diameter to each allergen. * A clinical reaction during a DBPCFC to small doses of food defined as a cumulative dose of =/\<444 mg food protein. * No clinical reaction observed during the placebo (oat) challenge. * Subject and/or parent guardian must be able to understand and provide informed consent. * Written informed consent from adult participants. * Written informed consent from parent/guardian for minor participants. * Written assent from minor participants as appropriate (e.g., at and above the age of 7 years). * Use of effective birth control by female participants of childbearing potential. Exclusion Criteria: * History of cardiovascular disease, including uncontrolled or inadequately controlled hypertension. * Individuals less than 15 kg in weight at start of the study * History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise or requiring intubation. * History of chronic disease (other than asthma, atopic dermatitis or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen. * History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD), symptoms of dysphagia (e.g., difficulty swallowing, food "getting stuck"), or recurrent gastrointestinal symptoms of undiagnosed etiology. * Severe asthma (NAEPP EPR-3 Medication Criteria Steps 5 or 6) * Mild or moderate asthma (NAEPP EPR-3 Medication Criteria Steps 1-4), if uncontrolled or difficult to control. * Uncontrolled asthma as evidenced by: * FEV1 \< 80% of predicted, or ratio of Forced Expiratory Volume in 1 second (FEV1) to forced vital capacity (FEV1/ Forced Vital Capacity (FVC)) \< 75% of predicted, with or without controller medications (only for age 6 or greater and able to do spirometry reliably. If unable to do spirometry, Peak Expiratory Flow (PEF) of \>80% is acceptable) or; * One overnight admission to a hospital in the past year for asthma or; * Emergency room (ER) visit for asthma within six months prior to screening. * Inability to tolerate biological (antibody) therapies. * Use of immunomodulator therapy (not including corticosteroids). * Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers. * Current participation or within the last 4 months in any other interventional study. * Pregnancy or lactation. * Allergy to oat (placebo in DBPCFC). * Use of investigational drugs within 16 weeks of participation. * In build up phase of immunotherapy for aeroallergens or venom.
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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.
Contacts and locations
Locations
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Sean N. Parker Center for Allergy & Asthma Research at Stanford University
Palo Alto, California, 94304, United States
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University of California Los Angeles (UCLA)
Los Angeles, California, 90095, United States
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University of California San Diego (UCSD)
San Diego, California, 92123, United States
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