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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
Must not have
Use of any other biologic (monoclonal antibody) medication within 12 weeks or 5 half-lives of drug, if known
Prior use or allergy to drugs related to abrocitinib (ruxolitinib, upadacitinib, etc)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and after 4 months of treatment
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am between 18 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken any biologic medication in the last 12 weeks or 5 half-lives.
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I am allergic to or have used drugs similar to abrocitinib.
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I haven't taken drugs like carbamazepine recently.
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I haven't taken CYP2C9 or CYP2C19 inhibitors recently.
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I cannot swallow pills.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
904 Previous Clinical Trials
541,765 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
~7 spots leftby Jun 2025
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