Food AllergyPhase 1NCT05069831
JAK Inhibition in Food Allergy
A Phase 1 study testing Abrocitinib in people with Food Allergy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Abrocitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 13 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
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.
- Conditions
- Food Allergy
- Being tested
- Abrocitinib
- Keywords
- Food Allergy, JAK, JAK Inhibitor, Abrocitinib, Immunoglobulin E
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbrocitinibDrug
Abrocitinib daily for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Abrocitinib 100mg | Active comparator | This arm will receive 100mg of the study drug Receives: Drug: Abrocitinib |
| Abrocitinib 200mg | Active comparator | This arm will receive 200mg of the study drug Receives: Drug: Abrocitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in basophil activation
change in basophil activation as measured by %CD63 AUC
Measured: baseline and after 4 months of treatment
change in skin prick test
change in skin prick test size after four months of therapy.
Measured: baseline and after 4 months of treatment
Secondary outcomes (3)
change in antigen-specific T-cell
change in antigen-specific T-cell response
Measured: baseline and after 4 months of treatment
change in specific immunoglobulin E (sIgE)
change in sIgE to allergic trigger food(s)
Measured: baseline and after 4 months of treatment
change in FENO
Fractional Exhaled Nitric Oxide (FeNO) level
Measured: baseline and after 4 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start16 May 2022
- Primary completion13 Jun 2025
- Study completion13 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single center, blinded, randomized pilot study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Sicherer, Icahn School of Medicine at Mount Sinai
- Investigators
- Scott Sicherer, MD, Study chair, Icahn School of Medicine at Mount SinaiEmma Guttman, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069831
- Sponsor's protocol ID
- GCO 21-0781
- Status last verified
- Jul 2025
- First submitted
- 25 Sep 2021
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: data will be provided as a manuscript
Publications
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.
PubMed 38814736
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JAK Inhibition in Food Allergy
- ClinicalTrials.gov ID
- NCT05069831
- Acronym / sponsor ID
- GCO 21-0781
- Conditions
- Food Allergy
- Keywords
- Food Allergy, JAK, JAK Inhibitor, Abrocitinib, Immunoglobulin E
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a single center, blinded, randomized pilot study.
| Arm | Type | Receives |
|---|---|---|
| Abrocitinib 100mg | Active comparator | Drug: AbrocitinibThis arm will receive 100mg of the study drug |
| Abrocitinib 200mg | Active comparator | Drug: AbrocitinibThis arm will receive 200mg of the study drug |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbrocitinibAbrocitinib daily for 4 months | Drug | Abrocitinib 100mg, Abrocitinib 200mg |
Primary outcome
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.
3 secondary outcomes
change in antigen-specific T-cell
Time frame: baseline and after 4 months of treatment
change in specific immunoglobulin E (sIgE)
Time frame: baseline and after 4 months of treatment
change in FENO
Time frame: baseline and after 4 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Derived from this study: PubMed 38814736Ghelli 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.
- Individual participant dataSharing planned: No. data will be provided as a manuscript
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Sicherer, MD study chair
Icahn School of Medicine at Mount Sinai
Emma Guttman, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abrocitinib in people with Food Allergy, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in basophil activation (time frame: baseline and after 4 months of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05069831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.