JAK Inhibition in Food Allergy

Phase 1

Recruiting

• Conditions: Food Allergy
• Interventions: Drug: Abrocitinib

• Registration Number: NCT05069831
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-25
• Study First Submitted QC: 2021-09-25
• Study First Posted: 2021-10-06
• Study Start: 2022-05-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-11
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abrocitinib 100mg	Abrocitinib	This arm will receive 100mg of the study drug
Abrocitinib 200mg	Abrocitinib	This arm will receive 200mg of the study drug

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States