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JAK Inhibition in Food Allergy

Primary Purpose

Food Allergy

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Abrocitinib
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Food Allergy focused on measuring Food Allergy, JAK, JAK Inhibitor, Abrocitinib, Immunoglobulin E

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Abrocitinib 100mg

Abrocitinib 200mg

Arm Description

This arm will receive 100mg of the study drug

This arm will receive 200mg of the study drug

Outcomes

Primary Outcome Measures

change in basophil activation
change in basophil activation as measured by %CD63 AUC
change in skin prick test
change in skin prick test size after four months of therapy.

Secondary Outcome Measures

change in antigen-specific T-cell
change in antigen-specific T-cell response
change in specific immunoglobulin E (sIgE)
change in sIgE to allergic trigger food(s)
change in FENO
Fractional Exhaled Nitric Oxide (FeNO) level

Full Information

First Posted
September 25, 2021
Last Updated
February 28, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT05069831
Brief Title
JAK Inhibition in Food Allergy
Official Title
JAK Inhibition in Food Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
Keywords
Food Allergy, JAK, JAK Inhibitor, Abrocitinib, Immunoglobulin E

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
This is a single center, blinded, randomized pilot study.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abrocitinib 100mg
Arm Type
Active Comparator
Arm Description
This arm will receive 100mg of the study drug
Arm Title
Abrocitinib 200mg
Arm Type
Active Comparator
Arm Description
This arm will receive 200mg of the study drug
Intervention Type
Drug
Intervention Name(s)
Abrocitinib
Intervention Description
Abrocitinib daily for 4 months
Primary Outcome Measure Information:
Title
change in basophil activation
Description
change in basophil activation as measured by %CD63 AUC
Time Frame
baseline and after 4 months of treatment
Title
change in skin prick test
Description
change in skin prick test size after four months of therapy.
Time Frame
baseline and after 4 months of treatment
Secondary Outcome Measure Information:
Title
change in antigen-specific T-cell
Description
change in antigen-specific T-cell response
Time Frame
baseline and after 4 months of treatment
Title
change in specific immunoglobulin E (sIgE)
Description
change in sIgE to allergic trigger food(s)
Time Frame
baseline and after 4 months of treatment
Title
change in FENO
Description
Fractional Exhaled Nitric Oxide (FeNO) level
Time Frame
baseline and after 4 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yair Bitton, MBA, MPH
Phone
347-466-2547
Email
yair.bitton@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Sicherer, MD
Email
scott.sicherer@mssm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Sicherer, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Emma Guttman, MD, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yair Bitton, MBA, MPH
Email
yair.bitton@mssm.edu
First Name & Middle Initial & Last Name & Degree
Scott Sicherer
Email
scott.sicherer@mssm.edu
First Name & Middle Initial & Last Name & Degree
Scott Sicherer, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
data will be provided as a manuscript

Learn more about this trial

JAK Inhibition in Food Allergy

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