Actively Recruiting
Effect of Omalizumab in the Skin of Food Allergy Patients
Led by National Jewish Health · Updated on 2025-05-02
40
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
N
National Jewish Health
Lead Sponsor
R
Roche-Genentech
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Omalizumab in the Skin of Food Allergy Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or parent/legal guardian can provide informed consent or assent
- Male or female aged 1 to 55 years at screening
- Total IgE level and weight allow for eligible omalizumab dosing
- Food sensitization to peanut, hen's egg, tree nut, sesame seed, cow's milk, wheat, or soy within 1 year
- Dose-limiting IgE-mediated symptoms at or before 444mg of food protein during screening oral food challenge
- Negative pregnancy test if female of child-bearing potential
- Agree to abstain or use contraception during treatment and for 60 days after last dose
- Willing to be trained on and have an epinephrine autoinjector available during the study
You will not qualify if you...
- Unable or unwilling to provide consent or comply with study protocol
- Clinically significant lab abnormalities at screening
- Known allergy to omalizumab or ingredients in oral food challenge materials other than study foods
- Poorly controlled atopic dermatitis or severe asthma/wheezing
- History of severe anaphylaxis requiring intubation to study food
- Recent treatment with steroids (over 2 days in last 30 days) except for asthma/wheezing
- Current use of corticosteroids, tricyclic antidepressants, or beta-blockers
- Past or current cancer or under investigation for cancer
- Previous adverse reaction to omalizumab
- Recent immunotherapy to oral food challenge food within 4 months
- Recent monoclonal antibody or immunomodulatory therapy within 4 months
- On build-up phase of inhalant allergen immunotherapy
- Unable to stop antihistamines for required wash-out periods
- Current participation in another clinical trial or investigational drug use within 24 weeks
- Pregnant, breastfeeding, or planning pregnancy during study or 60 days after last dose
- Skin diseases other than atopic dermatitis affecting skin barrier
- History of serious reaction to tape or adhesives
- Healthy controls must not have atopic dermatitis, autoimmune, or other confounding conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
Research Team
L
Lead Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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