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
13 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
This research aims to understand whether skin barrier problems occur in people with food allergies confirmed by positive oral food challenges (OFC). It also evaluates if these skin barrier issues can be improved with treatment using omalizumab. The study includes both food allergic participants and a comparison group of non-food allergic individuals to observe differences in skin barrier function. Participants with food allergies will receive omalizumab injections for four months and undergo multiple skin barrier tests, including transepidermal water loss (TEWL) and skin tape strip (STS) analyses. Oral food challenges will be performed before and after treatment to measure allergic reactions. A control group without food allergies will have similar skin barrier assessments but will not receive omalizumab. Participants will have an initial screening to confirm eligibility, including allergy tests and an oral food challenge. During the study, skin assessments will be done before doses and at the midpoint of treatment. After four months of omalizumab, a final oral food challenge and skin assessments will be completed. Researchers will analyze skin lipids, metabolites, proteins, and cytokines, tracking changes over five months to evaluate treatment effects and safety.
CONDITIONS
Brief 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 suitable for omalizumab dosing per study guidelines
- Food sensitization and dose-limiting IgE-mediated symptoms to specified foods confirmed by oral food challenge
- Negative pregnancy test if female of child-bearing potential; healthy controls self-report pregnancy status
- Women of child-bearing potential agree to abstinence or use acceptable contraception during treatment and 60 days after last dose
- Willing to be trained on and keep epinephrine autoinjector available throughout study
You will not qualify if you...
- Unable or unwilling to give informed consent or comply with study protocol
- Significant laboratory abnormalities at screening
- Allergy or sensitivity to ingredients related to study food or omalizumab
- Poorly controlled atopic dermatitis or severe asthma/wheezing at screening
- History of severe anaphylaxis to study food
- Recent use of steroids for non-asthma reasons or 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 study foods or monoclonal antibody treatments
- Currently in build-up phase of inhalant allergen immunotherapy
- Inability to stop antihistamines for required washout before tests
- Participation in other clinical trials within 90 days
- Use of investigational drugs within 24 weeks
- Pregnant, breastfeeding, or intending 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 control participants cannot have atopic dermatitis, autoimmune, or other conditions that could affect study results or samples
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 4 months
Participants with food allergy receive omalizumab injections for 4 months with regular skin barrier assessments.
Skin tape strip and transepidermal water loss assessments before doses 1, 2, and 3; and mid-treatment assessment at 2 months; injections administered by research nurse
Duration - Short-term after treatment
After 4 months of treatment, participants undergo an end of study oral food challenge and skin barrier assessments to evaluate treatment effect.
1 end of study oral food challenge visit with skin assessments
Trial Site Locations
Total: 1 location
1
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
Research Team
L
Lead Coordinator
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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