Effect of Omalizumab in the Skin of Food Allergy Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-55
SponsorNational Jewish Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participant and/or parent/legal guardian must be able to understand and provide informed consent and/or assent, as applicable.
Male or female, 1-55 years old at screening.
Total IgE level within 1 year of screening and weight at screening visit that together result in an eligible omalizumab dose according to the dosing table for FA (Appendix 8).
Participant must meet the following clinical FA criteria: Food sensitization to peanut, hen's egg, a tree nut, sesame seed, cow's milk, wheat, or soy, within 1 year of screening AND experience dose-limiting, IgE mediated symptoms at or before 444mg of food protein cumulatively during screening OFC to peanut, hen's egg, a tree nut, sesame seed, cow's milk, wheat, or soy.
Disqualifiers
Inability or unwillingness of a participant and/or parent/legal guardian to give written informed consent and/or assent or comply with the study protocol.
Clinically significant laboratory abnormalities at Screening.
Sensitivity or suspected/known allergy to any ingredients (including excipients) of the active OFC material (other than the study food), or drugs related to omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin).
Poorly controlled AD at Screening, per the PI's discretion.
Trial design
Design model
Parallel
Treatments tested in this trial
Omalizumab Injection
DrugOmalizumab is a monoclonal antibody FDA-approved for treatment of food allergy.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Participants with Food AllergyActive comparator 1 intervention
Group B: Participants without Food AllergyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Lipidomic analysis
Lipid measurements from Skin Tape Strips (STS), as detected at respective m/z from mass spectrometry
Time frame
5 months2
Metabolomic analysis
Metabolomics from STS, evaluated as a relative signal proportion of metabolites against the sum of all signals in the samples
Time frame
5 months3
Proteomic analysis
Proteomics from STS, comparison of global protein expression before vs after omalizumab treatment
Time frame
5 months4
Cytokine analysis
Cytokine levels from STS measured using preconfigured multiplex assays normalized to the total protein in each sample. Cytokines that will be measured: IL-1a, IL-1b, IL-18, IL-6, IL-8, TARC, MDC, TSLP, IL-33, IL-4, IL-13, IL-22, IL-31, eotaxins, IL-10, IL-17A/F, IL-17C, IL-12p70, IL-23, IP-10
Time frame
5 monthsSecondary outcomes
1
Measurement of Transepidermal Water Loss in non Food-Allergic Subjects
Transepidermal Water Loss (TEWL), grams water per square meter per hour (g/m\^2/h)
Time frame
5 months2
Lipidomic analysis in non Food-Allergic participants
Lipid measurements from Skin Tape Strips (STS), as detected at respective m/z from mass spectrometry
Time frame
5 months3
Metabolomic analysis in non Food-Allergic Participants
Metabolomics from STS, evaluated as a relative signal proportion of metabolites against the sum of all signals in the samples
Time frame
5 months4
Proteomic analysis in non Food-Allergic Participants
Proteomics from STS, baseline expression levels of proteins found in non-allergic skin tapes.
Time frame
5 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Jewish Health
Lead sponsor
Roche-Genentech
Collaborator
Source ClinicalTrials.gov