JAK Inhibition in Food Allergy

Mount Sinai Health System

Status and phase: Enrolling; Phase 1

Conditions: Food Allergy

Treatments: Drug: Abrocitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05069831

GCO 21-0781

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Abrocitinib 100mg

Active Comparator group

Description:

This arm will receive 100mg of the study drug

Treatment:

Drug: Abrocitinib

Abrocitinib 200mg

Active Comparator group

Description:

This arm will receive 200mg of the study drug

Treatment:

Drug: Abrocitinib