Omalizumab given by weight for food allergy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study enrolls people with confirmed food allergy (peanut, cashew, walnut, egg, or milk) who meet skin test, specific IgE, and oral food challenge criteria. Participants who qualify will receive omalizumab dosed by weight at either 5 mg/kg or 15 mg/kg, which is higher than current FDA-approved dosing for some indications. The trial monitors safety, tolerability, and changes in allergic reactivity, including responses on oral food challenge. A key goal is to determine whether weight-based dosing can include people with very high IgE who are typically excluded from standard dosing rules.

Why it matters

Who can join: the full rules

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.

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• University of North Carolina at Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• University of Texas Southwestern
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Wayne Shreffler, MD, PhD — Massachusetts General Hospital
• Study coordinator: Jannat Gill
• Email: Jgill@mgh.harvard.edu
• Phone: 617-643-8683

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.