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
Qualifiers
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
Treatments tested in this trial
- Omalizumab Injection
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
National Jewish Health
Lead sponsor
Roche-Genentech
Collaborator
Source ClinicalTrials.gov