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Monoclonal Antibodies
Omalizumab for Food Allergy
Phase 4
Waitlist Available
Research Sponsored by National Jewish Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female, 1-55 years old at screening
Be younger than 65 years old
Must not have
Currently receiving certain medications like corticosteroids, tricyclic antidepressants, or β-blockers
Poorly controlled or severe asthma/wheezing at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Summary
This trial aims to investigate if individuals with food allergies have skin barrier issues that can be improved with a medication called omalizumab. They will compare the skin barrier of food allergic participants before and
Who is the study for?
This trial is for individuals with confirmed food allergies, as shown by a positive oral food challenge. Participants will receive Omalizumab injections and undergo skin assessments to see if the treatment improves skin barrier issues related to their allergy.
What is being tested?
The study tests whether Omalizumab can reverse skin abnormalities in those with food allergies. Allergic participants get four months of treatment and two oral challenges, while non-allergic controls are observed for comparison.
What are the potential side effects?
Potential side effects of Omalizumab may include irritation at the injection site, headaches, fatigue, joint pain, and possible allergic reactions like hives or breathing difficulties.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 1 and 55 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medications such as corticosteroids, antidepressants, or β-blockers.
Select...
I have severe or poorly controlled asthma.
Select...
I have or am being checked for cancer.
Select...
I do not have any skin conditions affecting the outer layer of my skin besides atopic dermatitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Lipidomic analysis
Measurement of Transepidermal Water Loss
Metabolomic analysis
+1 moreSecondary study objectives
Cytokine analysis
Lipidomic analysis in non Food-Allergic participants
Measurement of Transepidermal Water Loss in non Food-Allergic Subjects
+2 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Participants without Food AllergyActive Control1 Intervention
This group will undergo skin barrier assessment.
Group II: Participants with Food AllergyActive Control1 Intervention
This group will receive 4 months of Omalizumab treatment, and undergo regular skin barrier assessments.
Find a Location
Who is running the clinical trial?
National Jewish HealthLead Sponsor
144 Previous Clinical Trials
317,334 Total Patients Enrolled
3 Trials studying Food Allergy
320 Patients Enrolled for Food Allergy
Roche-GenentechIndustry Sponsor
26 Previous Clinical Trials
3,751 Total Patients Enrolled