COMPLETED

JAK Inhibition in Food Allergy

Conditions

Food Allergy JAK JAK Inhibitor Abrocitinib Immunoglobulin E

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

JAK Inhibition in Food Allergy

Quick Facts

Study Start:2022-05-16

Study Completion:2025-06-13

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05069831

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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): * 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.	* 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

Inclusion Criteria

Exclusion 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):
* 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.

* 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

Principal Investigator

Scott Sicherer, MD

STUDY_CHAIR

Icahn School of Medicine at Mount Sinai

Emma Guttman, MD, PhD

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

Scott Sicherer, MD, STUDY_CHAIR, Icahn School of Medicine at Mount Sinai
Emma Guttman, MD, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

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

Study Start Date2022-05-16

Study Completion Date2025-06-13

Study Record Updates

Study Start Date2022-05-16

Study Completion Date2025-06-13

Terms related to this study

Keywords Provided by Researchers

Food Allergy
JAK
JAK Inhibitor
Abrocitinib
Immunoglobulin E

Additional Relevant MeSH Terms

Food Allergy