Recruiting
Phase 4

Omalizumab

Sponsor:

Johns Hopkins University

Code:

NCT07845552

Conditions

Food Allergy

Eligibility Criteria

Sex: All

Age: 1 - 30

Healthy Volunteers: Not accepted

Interventions

Omalizumab

Study Details

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

Study ID

NCT07845552

Start date

Oct 19, 2026

Status verified date

Oct, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: omalizumab

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.

Interventions

Omalizumab

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.

Primary outcome measure

  • Proportion of participants achieving pre-specified thresholds without dose-limiting symptoms during first post-treatment oral food challenge. [ Time Frame: Between ≥14 and ≤35 days after starting omalizumab ]

Central Contacts and Locations

Central contacts

Hao Tseng, MD

410-955-5883htseng9@jh.edu

Robert Wood, MD

410-955-5883rwood@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Kim Mudd

410-955-5883kmudd2@jhmi.edu

Robert Wood, MD

410-955-5883rwood@jhmi.edu

Principal Investigator:

Robert Wood, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Keywords

  • food allergy
  • omalizumab
  • oral food challenge

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.