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OpenTrials
Completed

NCT Number: NCT05069831

JAK Inhibition in Food Allergy

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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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abrocitinib

Drug

Abrocitinib daily for 4 months

Primary outcomes

  1. change in basophil activation

    Time frame: baseline and after 4 months of treatment

    change in basophil activation as measured by %CD63 AUC

  2. change in skin prick test

    Time frame: baseline and after 4 months of treatment

    change in skin prick test size after four months of therapy.

Secondary outcomes

  1. change in antigen-specific T-cell

    Time frame: baseline and after 4 months of treatment

    change in antigen-specific T-cell response

  2. change in specific immunoglobulin E (sIgE)

    Time frame: baseline and after 4 months of treatment

    change in sIgE to allergic trigger food(s)

  3. change in FENO

    Time frame: baseline and after 4 months of treatment

    Fractional Exhaled Nitric Oxide (FeNO) level

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 6, 2021
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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