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JAK Inhibitor

Abrocitinib for Food Allergy

Phase 1
Recruiting
Led By Emma Guttman, MD, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 - 50 years old
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and after 4 months of treatment
Awards & highlights

Study Summary

This trial will study whether abrocitinib can help treat food allergy patients and avoid the need for injections.

Who is the study for?
This trial is for adults aged 18-50 with IgE-mediated food allergies to specific foods like peanuts or shrimp, who have had allergic reactions and avoid these foods. They must be able to consent, not be pregnant or agree to contraception if applicable, stay in the Tri-State area during the study, and avoid UV light exposure.Check my eligibility
What is being tested?
The trial is testing abrocitinib, an oral medication previously used for atopic dermatitis, as a potential treatment for food allergies. It aims to provide a non-injection option that could treat both conditions in patients with multiple atopic disorders.See study design
What are the potential side effects?
Potential side effects of abrocitinib may include issues related to its immune-modulating effects such as infections or inflammation. As it's been studied in other conditions like atopic dermatitis, similar side effects are expected but specifics will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 50 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and after 4 months of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and after 4 months of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
change in basophil activation
change in skin prick test
Secondary outcome measures
change in FENO
change in antigen-specific T-cell
change in specific immunoglobulin E (sIgE)

Trial Design

2Treatment groups
Active Control
Group I: Abrocitinib 100mgActive Control1 Intervention
This arm will receive 100mg of the study drug
Group II: Abrocitinib 200mgActive Control1 Intervention
This arm will receive 200mg of the study drug

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,436 Total Patients Enrolled
6 Trials studying Food Allergy
233 Patients Enrolled for Food Allergy
Scott Sicherer, MDStudy ChairIcahn School of Medicine at Mount Sinai
7 Previous Clinical Trials
837 Total Patients Enrolled
2 Trials studying Food Allergy
133 Patients Enrolled for Food Allergy
Emma Guttman, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
7 Previous Clinical Trials
377 Total Patients Enrolled

Media Library

Abrocitinib (JAK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05069831 — Phase 1
Food Allergy Research Study Groups: Abrocitinib 100mg, Abrocitinib 200mg
Food Allergy Clinical Trial 2023: Abrocitinib Highlights & Side Effects. Trial Name: NCT05069831 — Phase 1
Abrocitinib (JAK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05069831 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What indications does Abrocitinib 100mg typically treat?

"Patients whose condition has been identified as requiring a therapeutic procedure, who have experienced the failure of one or more systemic therapies and are candidates for additional systemic therapy may be administered Abrocitinib 100mg."

Answered by AI

Is this experiment a pioneering endeavor?

"Pfizer's Abrocitinib 100mg drug is currently the subject of 2 active trials across 210 cities and 28 countries. The first study, launched in 2018 as part of Phase 3 for drug approval, enrolled over 3000 participants to evaluate its efficacy. Since then, 26 additional investigations have been conducted concerning this medication."

Answered by AI

Is Abrocitinib 100mg a dangerous dosage for individuals?

"Due to the limited clinical data available on Abrocitinib 100mg, our team at Power has assigned it a score of 1 in terms of safety. This is an initial Phase 1 trial and there are only preliminary findings regarding efficacy."

Answered by AI

Is the age requirement for this trial higher than 35 years?

"The age restriction for eligibility in this trial is between 18 and 50 years old. By contrast, there are 86 studies available to those younger than 18, while 159 trials exist that seek patients 65 or older."

Answered by AI

Are there any previous experiments conducted with Abrocitinib 100mg that could be referenced?

"At the moment, there is one Phase 3 study and another currently in progress for Abrocitinib 100mg. Most of these trials are situated near Saint Petersburg, Maryland but it can be found at 562 other locations across the world."

Answered by AI

What are the qualifications for participation in this scientific endeavor?

"This research study is currently enlisting 40 individuals with food allergies in the 18 - 50 age range. To be eligible, they must exhibit an history of allergic reactions to peanuts, cashew nuts, walnuts, hazelnuts, sesame seeds cod and/or shrimp; have a positive IgE skin or serum test result; practice avoidance of the allergenic foods; carry physician-prescribed epinephrine injectors at all times; possess eczema current or past; if female and of childbearing potential should provide proof that she isn't pregnant before enrolling and agree to abstinence from sexual activity during the trial period or use"

Answered by AI

How many people have enrolled in this medical research project?

"Affirmative. According to the data hosted by clinicaltrials.gov, this research is currently in search of participants with its initial posting date on May 16th 2022 and latest edit occurring on July 29th 2022. This study requires 40 patients from a single site location."

Answered by AI

Is this experimentation currently seeking out participants?

"Affirmative. According to information listed on clinicaltrials.gov, this medical study has been available since May 16th 2022 and was last updated in July 29th 2022; seeking a total of 40 participants from 1 site."

Answered by AI
~7 spots leftby Oct 2024