Oral Food Challenge After One to Two Doses of Omalizumab Treatment for Food Allergy

NCT07845552 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB00570914
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn how quickly omalizumab begins to work in people with food allergy. The main question it aims to answer is:

• Does omalizumab begin to work as early as 2 to 4 weeks after after starting treatment in people with food allergy? Researchers will compare each participant's food challenge results at baseline before starting omalizumab, 2 to 4 weeks after starting omalizumab, and 4 to 6 months after starting omalizumab treatment. Participants will:
• Have a baseline food challenge before starting omalizumab.
• Start omalizumab treatment as prescribed by the participant's doctor as part of regular clinical care.
• Have food challenges 2 to 4 weeks after starting omalizumab and again 4 to 6 months after starting omalizumab.
• Have skin prick testing and blood tests at study visits.

Conditions

Food Allergy

Keywords

food allergy; omalizumab; oral food challenge

Outcome Measures

Primary Outcomes (1)

• Proportion of participants achieving pre-specified thresholds without dose-limiting symptoms during first post-treatment oral food challenge.

  The pre-specified thresholds for response is defined as the ability to consume at least two more incremental doses of food protein during post-treatment oral food challenge (using incremental doses of 3, 10, 30, 100, 300, 600, 1000, 2000, 2000, and 2000 mg), than during the baseline oral food challenge. First post-treatment oral food challenge conducted between ≥14 and ≤35 days after starting omalizumab (after one or two doses of omalizumab depending on whether the participant is receiving omalizumab every 2 or 4 weeks).

  Between ≥14 and ≤35 days after starting omalizumab

Secondary Outcomes (2)

• The absolute change in oral food challenge threshold between baseline and the first post-treatment oral food challenge.

  Baseline, between ≥14 and ≤35 days after starting omalizumab

• The absolute change in oral food challenge threshold between the first and second post-treatment oral food challenges.

  between ≥14 and ≤35 days after starting omalizumab, 4-6 months after starting omalizumab

Other Outcomes (1)

• Association between oral food challenge outcomes and biomarkers including skin prick testing, allergen-specific IgE, total IgE, and free total IgE.

  At baseline, between ≥14 and ≤35 days starting omalizumab, and 4 to 6 months after starting omalizumab

Study Arms (1)

omalizumab

EXPERIMENTAL

Omalizumab is approved by the FDA for the treatment of food allergy in patients aged 1 year and older. Omalizumab is administered as a subcutaneous injection at doses ranging from 75 mg to 600 mg every 2 or 4 weeks. Omalizumab treatment is not provided as part of this study. Participants will receive omalizumab treatment as part of their routine care for food allergy as prescribed by their doctor in the clinical setting.

Drug: Omalizumab

Interventions

Omalizumab DRUG

Prior to starting omalizumab, participants will undergo a baseline oral food challenge. Participants will then initiate omalizumab treatment as prescribed by their doctor as part of routine clinical care. After 2 to 4 weeks of treatment (following one to two doses of omalizumab), participants will undergo a first post-treatment oral food challenge to assess treatment response. After 4 to 6 months of omalizumab treatment, participants will undergo a second post-treatment oral food challenge. The study will conclude following the second post-treatment oral food challenge.

omalizumab

Eligibility Criteria

• Age: 1 Year - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 1 to 30 years.
• Patients with diagnosed food allergy to at least one of the following foods (milk, egg, wheat, peanut, cashew, or walnut) who were prescribed omalizumab for food allergy in the clinical setting at the Johns Hopkins pediatric or adult allergy clinic.
• Positive food-specific IgE (≥2.0 kUA/L) to the relevant food OR a positive skin-prick test with a wheal ≥4 mm larger than the saline control.
• Positive open oral food challenge at baseline screening evaluation to the relevant food with dose-limiting symptoms at a single dose of ≤1000 mg (cumulative dose of ≤2043 mg) prior to starting omalizumab (using incremental doses of 3, 10, 30, 100, 300, 600, 1000 mg).
• Prior authorization from the patient's insurance provider for clinical use of omalizumab.

You may not qualify if:

• Clinically significant laboratory abnormalities in the past 6 months.
• 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 the participant-specific food that will be used in this study, defined as neurological compromise or requiring intubation.
• Currently receiving oral, intramuscular (IM), or intravenous (IV) corticosteroids, tricyclic antidepressants, or β-blockers.
• Past or current history of cancer, or currently being investigated for possible cancer.
• Past or current history of any food immunotherapy, such as 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 test or oral food challenge.
• Pregnant or breastfeeding, or intending to become pregnant during the study
• Evidence of clinically significant chronic disease.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Robert Wood, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Tseng, MD

CONTACT

410-955-5883; htseng9@jh.edu

Robert Wood, MD

CONTACT

410-955-5883; rwood@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Omalizumab treatment is prescribed by the participant's doctor as part of routine clinical care and is not provided by this study.

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)