Status:
RECRUITING
Omalizumab Weight-Based Dosing Efficacy Trial
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Allergies
Food Allergy
Eligibility:
All Genders
1-55 years
Phase:
PHASE2
Brief Summary
This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.
Detailed Description
This research is being conducted to assess the safety and effectiveness of omalizumab for food allergies dosed differently from what is currently FDA approved. The study hypothesizes the current way o...
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
- (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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06943534
Start Date
June 1 2025
End Date
April 1 2028
Last Update
May 31 2025
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
3
University of Texas Southwestern
Dallas, Texas, United States, 75390