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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	1 Year - 55 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion 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)
Exclusion Criteria:
- 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06934200
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Johns Hopkins University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Robert Wood, MD
Principal Investigator Affiliation	Johns Hopkins University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Hypersensitivity

Arms & Interventions

Arms

Other: Treatment with omalizumab

This is an open label study of omalizumab with no placebo. Participants who meet study inclusion criteria and are enrolled in the study will receive omalizumab. The dose of omalizumab will be based on participant's weight.

Interventions

Drug: - Omalizumab

omalizumab injections

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Johns Hopkins, Baltimore, Maryland

Status

Address

Johns Hopkins

Baltimore, Maryland, 21287

Site Contact

[email protected]

410-955-5883

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