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Omalizumab Dosing for Food Allergies

This study is looking at how different doses of omalizumab injections might help people with food allergies. Researchers want to see if higher doses of omalizumab are safe and effective, especially for individuals with very high allergic antibody (IgE) levels, who might not be helped by current dosing. You could be eligible if you are between 1 and 55 years old and have allergies to foods like peanut, cashew, walnut, egg, or milk, confirmed by skin prick tests and blood tests (IgE levels). The main goal is to see how many participants can tolerate a 600 mg dose of food after 16 weeks of treatment. The study aims to enroll 30 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It will involve 30 participants and is exploring two different doses of omalizumab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 16 weeks after treatment, indicating a follow-up period of at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06943534

Omalizumab Weight-Based Dosing Efficacy Trial

Recruiting
PHASE2Ages 1–55InterventionalTreatment
Massachusetts General Hospital
~30 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:5mg/kg omalizumab injection15mg/kg omalizumab injection

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants that tolerate the 600 mg dose after treatment.
Measured over 16 Weeks

Conditions

Allergies
Food Allergy

Explore related trials

Food AllergyIgE

Where it's being run

3 sites across 3 states
Massachusetts1
North Carolina1
Texas1

Study leadership

  • Wayne Shreffler, MD, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Jannat Gill
[email protected]
617-643-8683
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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.

What this trial measures

  • Proportion of participants that tolerate the 600 mg dose after treatment.16 Weeks

    The primary analysis of outcome is on the proportion of subjects tolerating at least 600 mg at the post-treatment OFC in either group against the expected outcome without treatment based on OUTMATCH data.