JAK Inhibition in Food Allergy

NCT05069831 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: GCO 21-0781
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy

Keywords

Food Allergy; JAK; JAK Inhibitor; Abrocitinib; Immunoglobulin E

Outcome Measures

Primary Outcomes (2)

• change in basophil activation

  change in basophil activation as measured by %CD63 AUC

  baseline and after 4 months of treatment

• change in skin prick test

  change in skin prick test size after four months of therapy.

  baseline and after 4 months of treatment

Secondary Outcomes (3)

• change in antigen-specific T-cell

  baseline and after 4 months of treatment

• change in specific immunoglobulin E (sIgE)

  baseline and after 4 months of treatment

• change in FENO

  baseline and after 4 months of treatment

Study Arms (2)

Abrocitinib 100mg

ACTIVE COMPARATOR

This arm will receive 100mg of the study drug

Drug: Abrocitinib

Abrocitinib 200mg

ACTIVE COMPARATOR

This arm will receive 200mg of the study drug

Drug: Abrocitinib

Interventions

Abrocitinib DRUG

Abrocitinib daily for 4 months

Abrocitinib 100mg; Abrocitinib 200mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Ghelli C, Costanzo G, Canonica GW, Heffler E, Paoletti G. New evidence in food allergies treatment. Curr Opin Allergy Clin Immunol. 2024 Aug 1;24(4):251-256. doi: 10.1097/ACI.0000000000000999. Epub 2024 May 30.

  PMID: 38814736 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Scott Sicherer, MD

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

• Emma Guttman, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatrics

Model Details: This is a single center, blinded, randomized pilot study.

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: October 6, 2021
• Study Start: May 16, 2022
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)