JAK Inhibition in Food Allergy

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Recruiting

CT.gov ID

NCT05069831

Collaborator

(none)

Enrollment

Location

Arms

7.6

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Food Allergy	Drug: Abrocitinib	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a single center, blinded, randomized pilot study.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

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

change in basophil activation [baseline and after 4 months of treatment]
change in basophil activation as measured by %CD63 AUC
change in skin prick test [baseline and after 4 months of treatment]
change in skin prick test size after four months of therapy.

Secondary Outcome Measures

change in antigen-specific T-cell [baseline and after 4 months of treatment]
change in antigen-specific T-cell response
change in specific immunoglobulin E (sIgE) [baseline and after 4 months of treatment]
change in sIgE to allergic trigger food(s)
change in FENO [baseline and after 4 months of treatment]
Fractional Exhaled Nitric Oxide (FeNO) level

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

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