Icahn School of Medicine at Mount Sinai
New York, 10029, United States
NCT Number: NCT05069831
This study will assess the role for an oral targeted medication, abrocitinib, as a new treatment option for food allergy patients that would avoid injections. Abrocitinib, which has successfully completed phase three trials for atopic dermatitis, could serve as a single therapy for two conditions in many patients with multiple atopic conditions.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 1
New York, 10029, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
° Foods: peanut, cashew, walnut, hazelnut, sesame, cod, and/or shrimp, history of an acute allergic reaction (urticaria, angioedema, cough, wheeze, and/or repetitive vomiting within an hour of ingestion, and history of positive skin or serum IgE test, and current strict avoidance of the food, and current possession of physician-prescribed self-injectable epinephrine, and skin test wheal 5 mm or greater average diameter
Exclusion criteria
Abrocitinib daily for 4 months
Time frame: baseline and after 4 months of treatment
change in basophil activation as measured by %CD63 AUC
Time frame: baseline and after 4 months of treatment
change in skin prick test size after four months of therapy.
Time frame: baseline and after 4 months of treatment
change in antigen-specific T-cell response
Time frame: baseline and after 4 months of treatment
change in sIgE to allergic trigger food(s)
Time frame: baseline and after 4 months of treatment
Fractional Exhaled Nitric Oxide (FeNO) level
Icahn School of Medicine at Mount Sinai
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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