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

Phase 1

Completed

• Conditions: Immune System Diseases
• Interventions: Dietary Supplement: Food proteins; Drug: Omalizumab

• Registration Number: NCT01510626
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-16
• Primary Completion: 2014-04
• Status Verified: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One	Food proteins	-
One	Omalizumab	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events in the treatment population	2 years

Secondary Outcome Measures

Name	Time	Method
Number of subjects who reach 2g or more of food flour	2 years

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States