RECRUITING

Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels

Quick Facts

Study Start:2025-05-19

Study Completion:2027-10-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06934200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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 double-blind, placebo-controlled 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.

Inclusion Criteria

Exclusion 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 double-blind, placebo-controlled 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.

Contacts and Locations

Study Contact

Robert Wood, MD

CONTACT

410-955-5883

rwood@jhmi.edu

Principal Investigator

Robert Wood, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Robert Wood, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-19

Study Completion Date2027-10-15

Study Record Updates

Study Start Date2025-05-19

Study Completion Date2027-10-15

Terms related to this study

Keywords Provided by Researchers

omalizumab

Additional Relevant MeSH Terms

Food Hypersensitivity