Oral treatment for food allergies using abrocitinib

JAK Inhibition in Food Allergy

This study is testing if an oral medication called abrocitinib can help adults with food allergies manage their symptoms without needing injections.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (other)
• Drugs / interventions: dupilumab, abrocitinib, ruxolitinib, upadacitinib, immunotherapy, prednisone
• Locations: 1 site (New York, New York)
• Trial ID: NCT05069831 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of abrocitinib, an oral JAK inhibitor, as a treatment for patients with food allergies. The study aims to provide a non-injection alternative for managing IgE-mediated food allergies, potentially benefiting those with multiple atopic conditions. Participants will be monitored for their response to the medication, which has previously shown promise in treating atopic dermatitis. The trial is designed for adults aged 18 to 50 who meet specific allergy criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 50 with IgE-mediated food allergies to specific foods and a history of allergic reactions.

Not a fit: Patients with non-IgE-mediated food allergies or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a convenient oral option for managing food allergies, reducing reliance on injections.

How similar studies have performed: Previous studies have shown success with JAK inhibitors in treating other atopic conditions, suggesting potential for this novel application.

Eligibility 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

Where this trial is running

New York, New York

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Emma Guttman, MD, PhD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Nicole Ramsey

Conditions: Food Allergy, JAK, JAK Inhibitor, Abrocitinib, Immunoglobulin E