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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abrocitinib 100mg | Active Comparator | This arm will receive 100mg of the study drug |
|
| Abrocitinib 200mg | Active Comparator | This arm will receive 200mg of the study drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abrocitinib | Drug | Abrocitinib daily for 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in antigen-specific T-cell | change in antigen-specific T-cell response | baseline and after 4 months of treatment |
| change in specific immunoglobulin E (sIgE) | change in sIgE to allergic trigger food(s) |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38814736 | Derived | 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. |
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data will be provided as a manuscript
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 9, 2024 | Jul 1, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000634427 | abrocitinib |
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This is a single center, blinded, randomized pilot study.
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| baseline and after 4 months of treatment |
| change in FENO | Fractional Exhaled Nitric Oxide (FeNO) level | baseline and after 4 months of treatment |