Omalizumab for the Treatment of Food Allergy in Patients With Elevated Total IgE Levels
ConditionFood Hypersensitivity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-55
SponsorJohns Hopkins University
About this trial
In this project, the investigators would like to learn if 24 weeks (about 5 and a half months) of omalizumab injections, given every 2 weeks, will be safe and effective for food allergic people who have a total immunoglobulin E (IgE) above the current FDA approved dosing regimen enabling a person to increase tolerance to the food(s) that the person is allergic to.
The investigators would also like to learn if participants who demonstrate increased tolerance to food after 24 weeks of omalizumab, can introduce the food into the diet utilizing an additional 8 weeks (about 2 months) of twice weekly omalizumab injections.
Eligibility criteria
Qualifiers
Age 1 to 55 years
A positive prick skin test (PST) with a wheal ≥ 6 mm to at least one of the relevant foods (peanut, cashew, walnut, egg, milk, or wheat)
Positive food-specific IgE (≥2.0 kilo units of allergen-specific IgE per liter (kUA/L)) to at least one of the study specific foods
A weight / IgE level that would have excluded the participant from the OUTMATCH study based on the dosing table noted above
Disqualifiers
Clinically significant laboratory abnormalities at screening.
Dose-limiting symptoms during the blinded food challenge to placebo during the screening DBPCFC.
Poorly controlled or severe asthma/wheezing at screening
History of severe anaphylaxis to participant-specific foods that will be used in this study, defined as neurological compromise or requiring intubation.
Trial design
Treatments tested in this trial
- Omalizumab
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Johns Hopkins University
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov