Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 50 Years|
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Icahn School of Medicine at Mount Sinai|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Scott Sicherer, MDEmma Guttman, MD, PhD|
|Principal Investigator Affiliation||Icahn School of Medicine at Mount SinaiIcahn School of Medicine at Mount Sinai|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Active Comparator: Abrocitinib 100mg
This arm will receive 100mg of the study drug
Active Comparator: Abrocitinib 200mg
This arm will receive 200mg of the study drug
Drug: - Abrocitinib
Abrocitinib daily for 4 months
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.