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New treatment option for Food Hypersensitivity
Official title Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels
ClinicalTrials.gov ID: NCT06934200
What this study is testing
What is Omalizumab?
Omalizumab is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for food hypersensitivity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this project, the investigators would like to learn if 24 weeks (about 5 and a half months) of omalizumab injections, given every 2 weeks, will be safe and effective for food allergic people who have a total immunoglobulin E (IgE) above the current FDA approved dosing regimen enabling a person to increase tolerance to the food(s) that the person is allergic to. The investigators would also like to learn if participants who demonstrate increased tolerance to food after 24 weeks of omalizumab, can introduce the food into the diet utilizing an additional 8 weeks (about 2 months) of twice weekly omalizumab injections.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 55
You may be able to join if
- Age 1 to 55 years
- A positive prick skin test (PST) with a wheal ≥ 6 mm to at least one of the relevant foods (peanut, cashew, walnut, egg, milk, or wheat)
- Positive food-specific IgE (≥2.0 kilo units of allergen-specific IgE per liter (kUA/L)) to at least one of the study specific foods
- A weight / IgE level that would have excluded the participant from the OUTMATCH study based on the dosing table noted above
- Positive blinded, compared with an inactive treatment food challenge (DBPCFC) to one of the relevant foods at a cumulative dose of ≤144 mg (maximum...
You likely can't join if
- Clinically significant laboratory abnormalities at screening.
- Dose-limiting symptoms during the blinded food challenge to placebo during the screening DBPCFC.
- 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 or requiring...
- Treatment with a burst of oral, intramuscular (IM), or intravenous (IV) steroids of more than two days for an indication other than asthma/wheezing...
- Currently receiving oral, IM, or IV corticosteroids, tricyclic antidepressants, or β-blockers.
See the full eligibility criteria
- Age 1 to 55 years
- A positive prick skin test (PST) with a wheal ≥ 6 mm to at least one of the relevant foods (peanut, cashew, walnut, egg, milk, or wheat)
- Positive food-specific IgE (≥2.0 kilo units of allergen-specific IgE per liter (kUA/L)) to at least one of the study specific foods
- A weight / IgE level that would have excluded the participant from the OUTMATCH study based on the dosing table noted above
- Positive blinded, compared with an inactive treatment food challenge (DBPCFC) to one of the relevant foods at a cumulative dose of ≤144 mg (maximum tolerated dose ≤30 mg)
- Clinically significant laboratory abnormalities at screening.
- Dose-limiting symptoms during the blinded food challenge to placebo during the screening DBPCFC.
- 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 or 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., oral immunotherapy (OIT), sublingual immunotherapy (SLIT), epicutaneous immunotherapy (EPIT) within 6 months of screening.
- Treatment with monoclonal antibody therapy, such as omalizumab, dupilumab, benralizumab, mepolizumab, reslizumab, tezepelumab, or other immunomodulatory therapy within 6 months of screening.
- Inability to discontinue antihistamines for minimum wash-out periods required for skin prick tests (SPTs) or oral food challenges (OFCs).
- Pregnant or breastfeeding, or intending to become pregnant during the study
- Evidence of clinically significant chronic disease.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.