JAK Inhibition in Food Allergy

  • STATUS
    Recruiting
  • End date
    Jan 9, 2023
  • participants needed
    40
  • sponsor
    Icahn School of Medicine at Mount Sinai
Updated on 9 June 2022

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.

Details
Condition Food Allergy
Treatment Abrocitinib
Clinical Study IdentifierNCT05069831
SponsorIcahn School of Medicine at Mount Sinai
Last Modified on9 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

- 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
Atopic dermatitis (AD) diagnosis for at least 1 year with at least 7% current BSA involvement
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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