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Could a drug combo make food allergy treatment safer?

NCT ID NCT03181009

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

60 people

The number who actually took part.

Started

Jul 2017

Finished

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

2 to 25 years

Sex

Anyone

Healthy volunteers

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

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

  • Sean N. Parker Center for Allergy and Asthma Research at Stanford

    Mountain View, California, 94040, United States

  • UCLA

    Los Angeles, California, 90095, United States

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Other studies related to the condition(s) this trial covers.