FeNO as a Marker of Allergic Reactions to OFC and Response of OMA Treatment in Multiple FA

NCT06437171 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: ML45389
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase IV, open-label, single-center study to evaluate the change in FeNO as a marker of clinical response to OMA in participants with multiple FA.

Conditions

Food Allergy

Keywords

Food Allergy; Multiple Food Allergies; Biomarker

Outcome Measures

Primary Outcomes (1)

• FeNO change from baseline to week 52

  biomarker

  1 year

Secondary Outcomes (1)

• Time to change from baseline FeNO during OFC

  at baseline and at week 16

Study Arms (1)

Open Label Injection of Omalizumab

OTHER

Omalizumab dose and frequency based on baseline patient weight and total IgE

Biological: Omalizumab

Interventions

Omalizumab BIOLOGICAL

Omalizumab dose and frequency based on baseline subject weight and total IgE

Open Label Injection of Omalizumab

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet the following criteria for study entry:
• Able and willing to provide written informed consent from patient and parent or guardian and to comply with the study protocol.
• Age 6 years of age or older at Visit 1
• Documented history of food allergy to one or more of the following foods based on SPT performed at baseline visit:
• peanut
• milk
• egg
• tree nuts (Walnut/Pecan, Cashew/Pistachio, Almond, Hazelnut, Brazil nut)

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from study entry:
• Diagnosis of asthma requiring maintenance medication, including inhaled steroids, leukotriene modifiers, LABA/ICS, biologics medications (Intermittent asthma \[Step 1\] is allowed and defined according to the 2020 NAEPP guidelines (as 'asthma requiring only prn SABA use) and FEV1 \< 80% of predicted normal.
• Diagnosis of nasal polyps, cystic fibrosis or any respiratory condition that will skew normally occurring FeNO levels
• FeNO (measured in ppb) is lower than a value expected for the age, height, and gender of the participant or inability to perform respiratory collection maneuver
• Systemic steroids, leukotriene modifiers, or nasal steroids for any cause/diagnosis within 4 weeks of baseline
• Biologic use, for any diagnosis, within five half-lives of Screening
• Antibiotic use, systemic/oral/intramuscular, for any cause/diagnosis within 2 weeks of baseline
• Active smoker, cigarette, cigar, vape, recreational, and/or prior 10 pack year history
• Participant weight or IgE levels outside of the dosing table for OMA
• Known history of anaphylaxis/hypersensitivity to OMA
• Any medical condition that is serious or unstable that in the opinion of the PI could confound the study results and/or interfere with subject participation or adherence
• Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of OMA
• Women of childbearing potential must have a negative serum pregnancy test result during the screening period

Sponsors & Collaborators

• AAADRS Clinical Research Center: lead

Study Sites (1)

AAADRS Clinical Research Center

Coral Gables, Florida, 33134, 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 Design

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

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 31, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

US (1)