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

NCT06934200 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB00467873
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

omalizumab

Outcome Measures

Primary Outcomes (1)

• Number of participants without dose limiting symptoms

  Consumption of a single dose of 600mg or more of food protein without dose-limiting symptoms during the week 24 Double-blind, Placebo-controlled, Food Challenge

  24 weeks

Study Arms (1)

Treatment with omalizumab

OTHER

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.

Drug: Omalizumab

Interventions

Omalizumab DRUG

omalizumab injections

Treatment with omalizumab

Eligibility Criteria

• Age: 1 Year - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (1)

• Wood RA, Togias A, Sicherer SH, Shreffler WG, Kim EH, Jones SM, Leung DYM, Vickery BP, Bird JA, Spergel JM, Iqbal A, Olsson J, Ligueros-Saylan M, Uddin A, Calatroni A, Huckabee CM, Rogers NH, Yovetich N, Dantzer J, Mudd K, Wang J, Groetch M, Pyle D, Keet CA, Kulis M, Sindher SB, Long A, Scurlock AM, Lanser BJ, Lee T, Parrish C, Brown-Whitehorn T, Spergel AKR, Veri M, Hamrah SD, Brittain E, Poyser J, Wheatley LM, Chinthrajah RS. Omalizumab for the Treatment of Multiple Food Allergies. N Engl J Med. 2024 Mar 7;390(10):889-899. doi: 10.1056/NEJMoa2312382. Epub 2024 Feb 25.

  PMID: 38407394 RESULT

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

Robert Wood, MD

CONTACT

410-955-5883; rwood@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): October 15, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)