Omalizumab Weight-Based Dosing Efficacy Trial

Launched by MASSACHUSETTS GENERAL HOSPITAL · Apr 16, 2025

Keywords

ClinConnect Summary

The Omalizumab Weight-Based Dosing Efficacy Trial is a study aimed at understanding how effective and safe higher doses of a medication called Omalizumab are for treating food allergies. This trial is particularly focused on patients who have serious allergies to foods like peanuts, cashews, walnuts, eggs, or milk. To be eligible for this trial, participants need to show that they have a strong reaction to at least two of these foods through skin tests and blood tests, and must have had a previous allergic reaction to one of these foods.

During the trial, participants will receive Omalizumab and will be closely monitored for any side effects and how well the treatment works. It's important to note that this trial is not yet recruiting participants, and there are specific health conditions and treatments that would exclude someone from participating. For example, individuals who have had severe allergic reactions requiring emergency treatment or who are currently on certain medications may not qualify. This study hopes to provide valuable information that could help improve food allergy treatments in the future.

Gender

ALL

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.