NCT06437171

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

The Use of Exhaled Nitric Oxide as a Predictive Marker of Allergic Reactions to Oral Food Challenge and Clinical Response of Omalizumab Treatment in Subjects With Multiple Food Allergies

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: AAADRS Clinical Research Center · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

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with severe hypersensitivity reactions (e.g., stridor, angioedema, life-threatening change in vital signs) must be withdrawn from study treatment.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.

Conditions

• Food Allergy

Interventions

Type	Name	Description
BIOLOGICAL	Omalizumab	Omalizumab dose and frequency based on baseline subject weight and total IgE

Timeline

• Start date: 2024-06-03
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2024-05-31
• Last updated: 2025-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study