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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01510626

Enrollment

Registered

2012-01-16

Start date

2011-11-30

Completion date

2015-12-31

Last updated

2015-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune System Diseases

Keywords

Multiple food allergies

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.

Interventions

DIETARY_SUPPLEMENTFood proteins

Food proteins

DRUGOmalizumab

Drug

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame
Number of adverse events in the treatment population	2 years

Secondary

Measure	Time frame
Number of subjects who reach 2g or more of food flour	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026