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Active, not recruitingNCT06437171Updated Aug 14, 2025

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

A Phase 4 interventional study of Omalizumab in Food Allergy, sponsored by AAADRS Clinical Research Center. Active, not recruiting at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by AAADRS Clinical Research Center · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
6 Years and older
Sex
All
01

Study 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.

Read the detailed description

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. Twenty (20) participants will be enrolled over a 9-month enrollment period from an allergy and asthma medical specialty clinic. Should the participant meet all eligibility criteria, then following the Screening Period, the participant will be dosed with OMA and asked to continue to follow their food avoidance regimen.

Participants will return to the clinic every two weeks for 16-weeks, and then every 2 or 4-weeks (depending on dosing) for the remaining 36-weeks, for a total of 52-weeks. Primary endpoint analyses will occur at Week 16 and Week 52.

Description of XOLAIR treatment schedule:

Omalizumab will be dosed according to the OUtMATCH Study dosing. Patients will be monitored for acute hypersensitivity reactions for at least 61 minutes after the end of the injection. Epinephrine and parenteral diphenhydramine must be readily available for immediate use if required to treat a hypersensitivity reaction; site personnel must be able to detect and treat such reactions. Patients with severe hypersensitivity reactions (e.g., stridor, angioedema, life-threatening change in vital signs) must be withdrawn from study treatment.

All adverse events of systemic hypersensitivity reactions or anaphylactoid or anaphylaxis reactions must be reported within 24 hours to the Sponsor.

02

Conditions studied

  • Food Allergy

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Keywords

  • Food Allergy
  • Multiple Food Allergies
  • Biomarker
03

In context

Food Hypersensitivity

340 studies on the registry are indexed under Food Hypersensitivity; 85 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 211 interventional studies indexed under Food Hypersensitivity.

Browse Food Hypersensitivity studies →

Lead sponsor

AAADRS Clinical Research Center is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Open Label Injection of Omalizumab

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

    Biological: Omalizumab

Interventions

  • BiologicalOmalizumab

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

06

What researchers measure

Primary outcomes

  1. FeNO change from baseline to week 52

    biomarker

    Time frame: 1 year

Secondary outcomes

  1. Time to change from baseline FeNO during OFC

    biomarker

    Time frame: at baseline and at week 16

07

Study locations

1 site
  • AAADRS Clinical Research Center
    Coral Gables, Florida 33134, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06437171
Lead sponsor
AAADRS Clinical Research Center
Responsible party
Sponsor
First posted
May 31, 2024
Start date
Jun 3, 2024
Primary completion
Jul 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Aug 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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