At a glance
ClinicalIndex Comparison Record- ✓Age 4 to 55 years
- ✓Moderate to severe IgE-mediated allergy to at least one target food (milk, egg, peanut, almond, wheat, cashew, sesame seed, soy, pecan, walnut, or hazelnut)
- ✓Positive skin prick test (≥6 mm wheal diameter) OR ImmunoCAP IgE >4 kU/L for each allergen
- ✓Clinical reaction during double-blind placebo-controlled food challenge (DBPCFC) to <500 mg food protein
- ✕Previous adverse reaction to Xolair
- ✕Total IgE >1,500 kU/L at screening
- ✕History of severe anaphylaxis (requiring intubation or ICU admission) to target food allergens
- ✕History of oat allergy or objective reaction to placebo (oat) DBPCFC challenge
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Controlled, Blinded, Pilot Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients
In Brief
A Phase 2 clinical trial evaluating Xolair and Placebo for Food Allergy. Completed, enrolled 48 participants across 1 site.
Detailed Summary
This is a pilot randomized, double-blind, placebo controlled study which will be conducted at a single center. All participants will receive oral immunotherapy for their specific food allergies (limited to 5 of those food allergens in IND 14831). In a 3:1 ratio, 36\* participants will receive Xolair for 16 weeks while 12\* will receive corresponding placebo instead of Xolair. 12 controls will be enrolled who will receive no OIT and no Xolair. These 12 controls are not part of the randomization. The total number of participants randomized to the two arms is 48\*.
Study Details
Timeline
Interventions
Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria
Placebo