Effect of Omalizumab in the Skin of Food Allergy Patients

Part of paid clinical trials in Denver, Colorado.

Sponsor
National Jewish Health
Study ID
NCT06618963
Phase
PHASE4
Status
Recruiting
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Conditions

  • Food Allergy
  • Food Allergy in Children

Eligibility Criteria

Sex
ALL
Age
1 Year - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Omalizumab Injection — DRUG
    Omalizumab is a monoclonal antibody FDA-approved for treatment of food allergy.

Study Details

The goal of this interventional study is to evaluate whether skin barrier abnormalities occur in subjects with a food allergy, as determined by positive oral food challenge (OFC). The main question it aims to answer is whether these skin barrier abnormalities can be reversed by omalizumab. If there is a comparison group: Researchers will compare non-food allergic participants (who do not receive omalizumab) to see if they experience skin barrier abnormalities. All food allergic participants will receive 4 months of Omalizumab treatment as well as two Oral Food Challenges. Participants will all undergo skin barrier assessments.

Key Dates

Start date
Oct 1, 2024
Status verified
Sep 2024
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Participants with Food Allergy
    This group will receive 4 months of Omalizumab treatment, and undergo regular skin barrier assessments.
  • No Intervention: Participants without Food Allergy
    This group will undergo skin barrier assessment.

Primary Outcome Measure

Lipidomic analysis [ Time Frame: 5 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Jewish HealthDenverColorado80206
Lead Coordinator
[email protected]
303-398-1409

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By research site
National Jewish Health· Denver, CO

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