JAK Inhibition in Food Allergy

Food Allergy Clinical Trial

Official title:

JAK Inhibition in Food Allergy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05069831
• Other study ID #: GCO 21-0781
• Status: Recruiting
• Phase: Phase 1
• Start date: May 16, 2022
• Est. completion date: October 2024

Study information

• Verified date: January 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Yair Bitton, MBA, MPH
• Phone: 347-466-2547
• Email: yair.bitton[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• Abrocitinib
Abrocitinib daily for 4 months

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in basophil activation	change in basophil activation as measured by %CD63 AUC	baseline and after 4 months of treatment
Primary	change in skin prick test	change in skin prick test size after four months of therapy.	baseline and after 4 months of treatment
Secondary	change in antigen-specific T-cell	change in antigen-specific T-cell response	baseline and after 4 months of treatment
Secondary	change in specific immunoglobulin E (sIgE)	change in sIgE to allergic trigger food(s)	baseline and after 4 months of treatment
Secondary	change in FENO	Fractional Exhaled Nitric Oxide (FeNO) level	baseline and after 4 months of treatment