JAK Inhibition in Food Allergy

NCT ID: NCT05069831

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2025-06-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Abrocitinib 100mg

This arm will receive 100mg of the study drug

Group Type: ACTIVE_COMPARATOR

Abrocitinib

Intervention Type: DRUG

Abrocitinib daily for 4 months

Abrocitinib 200mg

This arm will receive 200mg of the study drug

Group Type: ACTIVE_COMPARATOR

Abrocitinib

Intervention Type: DRUG

Abrocitinib daily for 4 months

Interventions

Abrocitinib

Abrocitinib daily for 4 months

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Scott Sicherer

Professor, Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott Sicherer, MD

Role: STUDY_CHAIR

Icahn School of Medicine at Mount Sinai

Emma Guttman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38814736 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

GCO 21-0781

Identifier Type: -

Identifier Source: org_study_id