Food Allergy
Conditions
Keywords
Food Allergy, JAK, JAK Inhibitor, Abrocitinib, Immunoglobulin E
Brief summary
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.
Interventions
DRUGAbrocitinib
Abrocitinib daily for 4 months
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a single center, blinded, randomized pilot study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in basophil activation | baseline and after 4 months of treatment | change in basophil activation as measured by %CD63 AUC |
| change in skin prick test | baseline and after 4 months of treatment | change in skin prick test size after four months of therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in specific immunoglobulin E (sIgE) | baseline and after 4 months of treatment | change in sIgE to allergic trigger food(s) |
| change in FENO | baseline and after 4 months of treatment | Fractional Exhaled Nitric Oxide (FeNO) level |
| change in antigen-specific T-cell | baseline and after 4 months of treatment | change in antigen-specific T-cell response |
Countries
United States
Outcome results
None listed