JAK Inhibition in Food Allergy
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|ClinicalTrials.gov Identifier: NCT05069831|
Recruitment Status : Recruiting
First Posted : October 6, 2021
Last Update Posted : March 1, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Food Allergy||Drug: Abrocitinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is a single center, blinded, randomized pilot study.|
|Masking:||Double (Participant, Investigator)|
|Official Title:||JAK Inhibition in Food Allergy|
|Actual Study Start Date :||May 16, 2022|
|Estimated Primary Completion Date :||October 2024|
|Estimated Study Completion Date :||October 2024|
Active Comparator: Abrocitinib 100mg
This arm will receive 100mg of the study drug
Abrocitinib daily for 4 months
Active Comparator: Abrocitinib 200mg
This arm will receive 200mg of the study drug
Abrocitinib daily for 4 months
- change in basophil activation [ Time Frame: baseline and after 4 months of treatment ]change in basophil activation as measured by %CD63 AUC
- change in skin prick test [ Time Frame: baseline and after 4 months of treatment ]change in skin prick test size after four months of therapy.
- change in antigen-specific T-cell [ Time Frame: baseline and after 4 months of treatment ]change in antigen-specific T-cell response
- change in specific immunoglobulin E (sIgE) [ Time Frame: baseline and after 4 months of treatment ]change in sIgE to allergic trigger food(s)
- change in FENO [ Time Frame: baseline and after 4 months of treatment ]Fractional Exhaled Nitric Oxide (FeNO) level
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05069831
|Contact: Yair Bitton, MBA, MPHemail@example.com|
|Contact: Scott Sicherer, MDfirstname.lastname@example.org|
|United States, New York|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Contact: Yair Bitton, MBA, MPH email@example.com|
|Contact: Scott Sicherer firstname.lastname@example.org|
|Principal Investigator: Scott Sicherer, MD|
|Study Chair:||Scott Sicherer, MD||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Emma Guttman, MD, PhD||Icahn School of Medicine at Mount Sinai|
|Responsible Party:||Scott Sicherer, Professor, Pediatrics, Icahn School of Medicine at Mount Sinai|
|Other Study ID Numbers:||
|First Posted:||October 6, 2021 Key Record Dates|
|Last Update Posted:||March 1, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||data will be provided as a manuscript|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
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