Clinical trial NCT05069831: JAK Inhibition in Food Allergy
Official title: JAK Inhibition in Food Allergy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Food Allergy
Keywords: Food Allergy
JAK
JAK Inhibitor
Abrocitinib
Immunoglobulin E
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single center, blinded, randomized pilot study.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: change in basophil activation
timeFrame: baseline and after 4 months of treatment
measure: change in skin prick test
timeFrame: baseline and after 4 months of treatment
Secondary outcomes:
measure: change in antigen-specific T-cell
timeFrame: baseline and after 4 months of treatment
measure: change in specific immunoglobulin E (sIgE)
timeFrame: baseline and after 4 months of treatment
measure: change in FENO
timeFrame: baseline and after 4 months of treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Scott Sicherer, MD
role: STUDY_CHAIR
affiliation: Icahn School of Medicine at Mount Sinai
name: Emma Guttman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: