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.
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with severe hypersensitivity reactions (e.g., stridor, angioedema, life-threatening change in vital signs) must be withdrawn from study treatment.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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Omalizumab dose and frequency based on baseline subject weight and total IgE
AAADRS Clinical Research Center
Coral Gables, Florida, United States
FeNO change from baseline to week 52
biomarker
Time frame: 1 year
Time to change from baseline FeNO during OFC
biomarker
Time frame: at baseline and at week 16
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