Recruiting
Phase 1

Zileuton

Sponsor:

Abigail Lang

Code:

NCT07935616

Conditions

Food Allergies

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Zileuton extended release

Study Details

Brief summary:

Our proposed project will seek to determine if an oral medication called zileuton, which blocks the synthesis of inflammatory molecules called leukotrienes that are involved in allergic reactions, may be able to decrease absorption of food allergens and prevent severe food allergy reactions from occurring. Our study will measure levels of peanut in the blood before and after subjects consume an allergen they can tolerate and compare the results with and without administration of the study medication, zileuton. If our study shows that zileuton can decrease the absorption of a food allergen, this will allow us to see if this medication can be used to prevent anaphylaxis to food.

The goal of this proof-of-concept study is to determine whether zileuton inhibits food allergen absorption in children and adolescents with food allergy. The main questions it aims to answer are:

  • Does zileuton administration impact food allergen absorption in children and adolescents with food allergies?
  • What is the variability of food allergen absorption in children and adolescents with IgE-mediated food allergies?

Researchers will compare levels of peanut allergen proteins in the participants' blood with and without a dose of zileuton prior to a test meal of peanut protein.

  • Visit 1 will involve a baseline blood draw, a test meal of peanut protein and a post-meal blood draw.
  • Visit 2 will involve a baseline blood draw, a dose of zileuton before the test meal of peanut protein, and blood draws after the test meal.

Conditions

Food Allergies

Study ID

NCT07935616

Start date

Nov 3, 2026

Status verified date

Nov, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adolescent subjects ages 12-17
  • Parent or guardian fluent in English
  • Known IgE-mediated food allergy other than peanut

  • Confirmed by clinical history of reaction to the food antigen plus

1. positive skin prick testing and/or serum food-specific IgE AND
2. confirmation of the food allergy diagnosis by a board-certified allergist

Exclusion Criteria:

  • A previous positive peanut specific IgE test or skin prick test, or a history of any allergic symptoms following peanut consumption
  • Medical conditions known to affect the gastrointestinal tract
  • Any history of hepatic disease or previous abnormal liver function tests
  • Previous hypersensitivity or anaphylaxis to zileuton
  • Current use of a medication known to interact with zileuton, such as theophylline, warfarin, or propranolol
  • History of drug or alcohol abuse
  • Use of any investigational drugs within 30 days of screening
  • Initiation of allergen immunotherapy within 3 months prior to Visit 1 or a plan to begin therapy during the trial
  • Use of leukotriene antagonists/modifier such as montelukast
  • Pregnant persons
  • Individuals with uncontrolled neuropsychiatric disorders
  • Use of oral corticosteroids (OCS) within 2 weeks before screening or are scheduled to receive OCS during the study period for another condition
  • Monoclonal antibody or immunosuppressive treatment within 3 months of screening
  • Past or current medical problems which in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or may compromise the quality of the data obtained from the study
  • Inability or unwillingness of a parent or guardian to give written informed consent or participant to give assent
  • Non-English speaking participants

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study treatment

Treatment with a single dose of Zileuton administered at Visit 2.

Interventions

Zileuton extended release

Zileuton is available in 600 mg strength yellow-colored oval tablets. A single dose of 1200 mg zileuton ER (two 600 mg zileuton tablets) will be administered to each participant.

Primary outcome measure

  • Inhibition of food allergy absorption by zileuton [ Time Frame: 1.25 hours pre-meal and 1 hour post-test meal (Visit 1, Baseline); 2.25 hours pre-test meal and 0.25, 0.5, 1 hour post-test meal (Visit 2, 7 days after Visit 1) ]

Central Contacts and Locations

Central contacts

Abigail Lang, MD, MSCI

800-543-7362AllergyResearchNurse@luriechildrens.org

Michelle Catalano, BS, LPN

800-543-7362MCatalano@luriechildrens.org

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Michelle Catalano, BS, LPN

800-543-7362MCatalano@luriechildrens.org

Principal Investigator:

Abigail Lang, MD, MSCI

More Information

Sponsor

Abigail Lang

Last update posted

Nov 13, 2026

Last verified

Nov, 2026

Keywords

  • food allergies
  • zileuton
  • anaphylaxis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-14. This information was provided to ClinicalTrials.gov by Abigail Lang on 2026-11-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.