Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center

Stanford University

Status and phase

Completed

Phase 1

Conditions

Immune System Diseases

Treatments

Drug: Omalizumab

Dietary Supplement: Food proteins

Study type

Interventional

Funder types

Other

Identifiers

NCT01510626

22872

Details and patient eligibility

About

The long-term goal of the investigators study is to develop a better and safer treatment for, and to potentially cure patients with single or multiple food allergies. The investigators hypothesize that the application of this protocol will allow patients with severe and single or multiple food allergies to be safely and rapidly desensitized.

Enrollment

35 patients

Sex

All

Ages

4 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old.
Sensitivity to food allergen will be documented by a positive skin prick test result or allergen-specific ImmunoCAP IgE level, with 7 kU/L as a lower limit of eligibility.

Exclusion criteria

No absolute contraindications are known. However, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers).
Subjects with a total IgE at screening of >2,000 kU/L
Previous reaction to omalizumab
Subjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.