Recruiting
Phase 2

Omalizumab

Sponsor:

Johns Hopkins University

Code:

NCT06934200

Conditions

Food Hypersensitivity

Eligibility Criteria

Sex: All

Age: 1 - 55

Healthy Volunteers: Not accepted

Interventions

Omalizumab

Study Details

Brief summary:

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.

Conditions

Food Hypersensitivity

Study ID

NCT06934200

Start date

May 19, 2025

Status verified date

Jun, 2026

Completion date

Oct 15, 2027

Anticipated

Primary completion date

Apr 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 55

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Omalizumab

omalizumab injections

Primary outcome measure

  • Number of participants without dose limiting symptoms [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Robert Wood, MD

410-955-5883rwood@jhmi.edu

Locations

Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Robert+ Wood, MD

410-955-5883pediatricallegy@JHMI.edu

Kim Mudd, RN

410-502-1711kmudd2@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • omalizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-08.