Omalizumab Weight-Based Dosing Efficacy Trial

Recruiting now · Phase 2

Conditions studied: Allergies, Food Allergy

In brief

This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.

Key facts

Study ID: NCT06943534
Run by: Massachusetts General Hospital
People needed: 30
Starts: 2025-07-03
Expected to finish: 2028-04-01
Last updated by the study team: 2026-02-05

Who can join

Age: 1 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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 is running

Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
University of Texas Southwestern — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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