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JAK Inhibition in Food Allergy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05069831
Recruitment Status : Recruiting
First Posted : October 6, 2021
Last Update Posted : March 1, 2023
Sponsor:
Information provided by (Responsible Party):
Scott Sicherer, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Food Allergy Drug: Abrocitinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a single center, blinded, randomized pilot study.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: JAK Inhibition in Food Allergy
Actual Study Start Date : May 16, 2022
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Abrocitinib

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05069831


Contacts
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Contact: Yair Bitton, MBA, MPH 347-466-2547 yair.bitton@mssm.edu
Contact: Scott Sicherer, MD scott.sicherer@mssm.edu

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Yair Bitton, MBA, MPH       yair.bitton@mssm.edu   
Contact: Scott Sicherer       scott.sicherer@mssm.edu   
Principal Investigator: Scott Sicherer, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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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
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Responsible Party: Scott Sicherer, Professor, Pediatrics, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT05069831    
Other Study ID Numbers: GCO 21-0781
First Posted: October 6, 2021    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: data will be provided as a manuscript

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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
Keywords provided by Scott Sicherer, Icahn School of Medicine at Mount Sinai:
Food Allergy
JAK
JAK Inhibitor
Abrocitinib
Immunoglobulin E
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Abrocitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action