Omalizumab given by weight for food allergy

Omalizumab Weight-Based Dosing Efficacy Trial

This study will test whether higher, weight-based doses of omalizumab are safe and help people with food allergies, including those with very high allergic antibody (IgE) levels, tolerate their allergens better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 1 Year to 55 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Drugs / interventions: omalizumab, immunotherapy
• Locations: 3 sites (Boston, Massachusetts and 2 other locations)
• Trial ID: NCT06943534 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults or children who have positive skin tests and specific IgE to at least two of the listed foods, a qualifying positive oral food challenge with low tolerated dose, weigh 80 kg or less, and do not have poorly controlled severe asthma or known allergy to omalizumab components.

Not a fit: People over 80 kg, those with poorly controlled or severe asthma, known sensitivity to omalizumab ingredients, or without the required diagnostic test results likely would not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could allow more people with high IgE food allergies to receive omalizumab and increase their ability to tolerate offending foods.

How similar studies have performed: Previous studies have shown omalizumab can help reduce allergic reactions and facilitate oral immunotherapy in some patients, but weight-based higher dosing specifically to include very-high-IgE individuals is less well studied and relatively novel.

Eligibility criteria

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 this trial is running

Boston, Massachusetts and 2 other locations

• 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

Conditions Allergies; Food Allergy; omalizumab