NCT06943534 · Massachusetts General Hospital
Omalizumab Weight-Based Dosing Efficacy Trial
(OWED-T)
What this study is about
This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.
View original scientific description
This research is being conducted to assess the safety and effectiveness of increased dosing of Omalizumab for food allergies.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 hypotensi
Where
- Boston, Massachusetts
- Chapel Hill, North Carolina
- Dallas, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2026 · Source of record for eligibility and locations