JAK Inhibition in Food Allergy

Study Overview
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Brief Summary
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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.

Official Title
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JAK Inhibition in Food Allergy

Conditions
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Food Allergy

Intervention / Treatment
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* Drug: Abrocitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 - 50 years old Participant must be able to understand and perform informed consent. IgE-mediated food allergy to at least one of the following foods as defined by (regarding at least one of the foods): ° 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 Current or past eczema. If female of childbearing potential, must have a negative pregnancy test (serum or urine) and agree to abstinence or acceptable contraception. Plan to remain in the Tri-State area during the trial for visits. Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sunlamps, or other ultraviolet (UV) light sources during the study. If receiving concomitant medications for any reason other than AD, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) prior to Day 1 and through the duration of the study. Exclusion Criteria: Unwilling or unable to give written informed consent or comply with protocol. Unable to swallow pill. Use of dupilumab within 6 weeks of enrollment. Prior use or allergy to drugs related to abrocitinib (ruxolitinib, upadacitinib, etc). Use of any other biologic (monoclonal antibody) medication within 12 weeks or 5 half-lives of drug, if known. Allergy to any excipients within abrocitinib. Use of build-up environmental immunotherapy; any food oral immunotherapy;or systemic oral, IV or IM steroids including but not limited to- prednisone, methylprednisolone, prednisolone, solumedrol, solucortef, dexamethasone in the past 4 weeks or 5 half-lives of drug, if known. Use of CYP2C9 and CYP2C19 inducers (such as carbamazepine, norfluoxetine, etc.) within 5 half-lives of the inducer plus 14 days prior to the first dose of study intervention. Use of CYP2C9 and CYP2C19 inhibitors within 1 week of first dose of study intervention or within 5 half-lives (if known) of the inhibitor, whichever is longer. Unable to stop long-acting antihistamines within minimum wash out period required for SPTs at screening and site visits History of or significant risk factor(s) for cardiovascular disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a single center, blinded, randomized pilot study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Abrocitinib 100mg<br>This arm will receive 100mg of the study drug | Drug: Abrocitinib<br>* Abrocitinib daily for 4 months<br>|
| Active Comparator: Abrocitinib 200mg<br>This arm will receive 200mg of the study drug | Drug: Abrocitinib<br>* Abrocitinib daily for 4 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in basophil activation | change in basophil activation as measured by %CD63 AUC | baseline and after 4 months of treatment | 
| change in skin prick test | change in skin prick test size after four months of therapy. | baseline and after 4 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in antigen-specific T-cell | change in antigen-specific T-cell response | baseline and after 4 months of treatment | 
| change in specific immunoglobulin E (sIgE) | change in sIgE to allergic trigger food(s) | baseline and after 4 months of treatment | 
| change in FENO | Fractional Exhaled Nitric Oxide (FeNO) level | baseline and after 4 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Allergy, JAK, JAK Inhibitor, Abrocitinib, Immunoglobulin E