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Monoclonal Antibodies

Omalizumab for Food Allergy

Phase 4
Recruiting
Research Sponsored by AAADRS Clinical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 6 years of age or older at Visit 1
Must not have
Systemic steroids, leukotriene modifiers, or nasal steroids for any cause/diagnosis within 4 weeks of baseline
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study how FeNO levels change in response to OMA treatment in individuals with multiple FA.

Who is the study for?
This trial is for individuals with multiple food allergies. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may need to have a history of allergic reactions to foods.
What is being tested?
The study is testing Omalizumab (OMA), an allergy medication, to see if it changes levels of FeNO—a marker that could indicate how well the treatment works for those with multiple food allergies.
What are the potential side effects?
While specific side effects are not listed here, Omalizumab can commonly cause symptoms like injection site reactions, headaches, and potential increased risk of heart and brain blood vessel problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 6 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken steroids or asthma medication in the last 4 weeks.
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I have asthma and need daily medication to manage it. My lung function is below 80% of what's expected.
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I haven't taken biologic medication within its last five half-lives before screening.
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I haven't taken any antibiotics by mouth or injection in the last 2 weeks.
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I currently smoke or have a history of heavy smoking.
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My FeNO levels are lower than expected for someone my age, height, and gender, or I cannot perform the breathing test.
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My weight or IgE levels don't match the dosing guidelines for OMA.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
FeNO change from baseline to week 52
Secondary study objectives
Time to change from baseline FeNO during OFC

Side effects data

From 2016 Phase 4 trial • 17 Patients • NCT02023151
77%
Infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Omalizumab

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open Label Injection of OmalizumabExperimental Treatment1 Intervention
Omalizumab dose and frequency based on baseline patient weight and total IgE
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omalizumab
2006
Completed Phase 4
~2350

Find a Location

Who is running the clinical trial?

AAADRS Clinical Research CenterLead Sponsor
2 Previous Clinical Trials
46 Total Patients Enrolled
~12 spots leftby Jul 2025
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