Could a drug combo make food allergy treatment safer?
NCT ID NCT03181009
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 study tested whether the drug omalizumab (Xolair) can make oral immunotherapy safer for people with multiple food allergies. Sixty participants aged 2 to 25 received omalizumab before gradually increasing doses of their problem foods. The goal was to see if this approach allows lower maintenance doses and reduces allergic reactions.
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 food flour allergens
- What this could lead to
- If successful, this could point toward a safer way to treat multiple food allergies at once, possibly allowing lower daily doses of allergens.
- What could go wrong
- This is a small, early-phase study (60 people) focused on immune markers, not long-term outcomes. Results may not apply to everyone, and allergic reactions remain a risk.
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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60 people
The number who actually took part.
- Started
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Jul 2017
- Finished
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Jan 2019
- Lead sponsor
-
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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2 to 25 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: * Aged 2 to 25 years with clinical history of allergy to at least two of the following: milk and/or egg and/or peanut and/or almond and/or wheat and/or cashew and/or sesame seed and/or soy and/or pecan and/or walnut and/or hazelnut and/or shrimp and/or cod and/or salmon and * Sensitivity to food allergens documented by a positive skin prick test result greater than or equal to 6mm wheal diameter to each allergen or * ImmunoCAP IgE level \>4kU/L for each allergen and * If female of child bearing potential, a negative urine pregnancy test before being allowed to participate in the study (week 0) and * A plan to remain in the study area of the research center during the trial and * Be trained on the proper use of the Epinephrine autoinjector and agree to follow epi training to be allowed to enroll in the study and * If female of child-bearing potential, willing to be compliant with a medically-approved method of contraception (please see Pregnancy section in this IND document) and * Agree to eliminate other known food allergens from subject's diet so as not to confound the safety and efficacy data from the study and * Avoid open or blinded food challenges to food allergens Exclusion Criteria: * Previous anaphylactic reaction to Omalizumab * A history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma * Unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that, in the judgment of the investigator, might interfere with the evaluation or administration of the test drug or pose additional risk to the subject (e.g., gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease) * An average forced expiratory volume at one second (FEV1) or peak expiratory flow rate (PEF) less than 80% predicted (moderate persistent asthma) with or without controller medication (if able to perform the maneuver) at screening, or a food challenge visit * Current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or are taking a beta-blocker (oral or topical) * Routinely using medication that could induce adverse gastrointestinal reactions during the study * Refusing to sign or follow the Epinephrine autoinjector Training Form * Pregnant or breast feeding women * Unwilling to avoid other allergens outside this study * Concurrent/prior use of immunomodulatory therapy (within 6 months) * A diagnosis of eosinophilic esophagitis, eosinophilic colitis, or eosinophilic gastritis.
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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 and Asthma Research at Stanford
Mountain View, California, 94040, United States
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UCLA
Los Angeles, California, 90095, United States
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