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.

Study Overview

• Status: Recruiting
• Conditions: Food Allergy
• Intervention / Treatment: Drug: Abrocitinib

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yair Bitton, MBA, MPH; Phone Number: 347-466-2547; Email: yair.bitton@mssm.edu
• Study Contact Backup: Name: Scott Sicherer, MD; Email: scott.sicherer@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Yair Bitton, MBA, MPH; Email: yair.bitton@mssm.edu
      • Contact: Scott Sicherer; Email: scott.sicherer@mssm.edu
      • Principal Investigator: Scott Sicherer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Abrocitinib 100mg; This arm will receive 100mg of the study drug	Drug: Abrocitinib; Abrocitinib daily for 4 months
Active Comparator: Abrocitinib 200mg; This arm will receive 200mg of the study drug	Drug: Abrocitinib; Abrocitinib daily for 4 months

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Study Chair: Scott Sicherer, MD, Icahn School of Medicine at Mount Sinai; Principal Investigator: Emma Guttman, MD, PhD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: September 25, 2021
• First Submitted That Met QC Criteria: September 25, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: JAK; Food Allergy; Abrocitinib; JAK Inhibitor; Immunoglobulin E
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Abrocitinib
• Other Study ID Numbers: GCO 21-0781

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data will be provided as a manuscript

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No