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.
Conditions:
🦠 Food Allergy
🗓️ Study Start (Actual) 16 May 2022
🗓️ Primary Completion (Estimated) October 2024
✅ Study Completion (Estimated) October 2024
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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: 18 Years to 50 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 September 2021
  • First Submitted that Met QC Criteria 25 September 2021
  • First Posted 6 October 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 January 2024
  • Last Update Posted 11 January 2024
  • Last Verified January 2024