NCT02643862

Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients

Randomized, Controlled, Blinded, Pilot Study Using Xolair in Rush Multi Oral Immunotherapy in Multi Food Allergic Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 4 Years – 55 Years
• Healthy volunteers: Not accepted

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\*.

Detailed description

We will enroll multi food allergic participants (4-55 years of age) with proven "multi food allergies". We anticipate enrolling 60 participants with allergies to, at least two foods. Participants must have food specific IgE\>4kU/L for each allergen or a skin test reactivity to each food allergen ≥ 6 mm wheal diameter. We have chosen criteria associated with a very low likelihood of natural loss of food allergy for the duration of this protocol. These values of specific IgE and SPT were chosen based on the opinions of 4 experts. Participants also must have a total IgE \<1500kU/L, a clinical reaction during a double blind placebo controlled food challenge (DBPCFC) with food proteins/powders to establish sensitivity to given food proteins/powders (milk, egg, peanut, almond, wheat, cashew, sesame seed, soy, walnut, hazelnut) and no clinical reaction during placebo (oat) as per CMC section of IND. Participants will undergo a rush desensitization day at week 8 to a maximum dose of 1,250 mg total protein. Participants will be ingesting either 2 to 5 food allergens, depending on their allergy screening. They will consume home doses for two weeks based on the these results and document reactions. Upon returning to the CFRU (Clinical Food Research Unit) two weeks later, a dose escalation will be attempted. This cycle will continue until the participant reaches a maximum dose of 2,000 mg protein daily of each food allergen (two to five food allergens to be ingested by the participant). No more than 5 allergens will be given.

Conditions

• Food Allergy

Interventions

Type	Name	Description
DRUG	Xolair	Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria
DRUG	Placebo	Placebo

Timeline

• Start date: 2015-03-18
• Primary completion: 2016-08-20
• Completion: 2016-08-20
• First posted: 2015-12-31
• Last updated: 2018-01-12
• Results posted: 2017-10-25

Locations

1 site across 1 country: United States