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

Immune System Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510626
• Other study ID #: 22872
• Status: Completed
• Phase: Phase 1
• First received: November 29, 2011
• Last updated: December 9, 2015
• Start date: November 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT02062814

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 55 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Food Hypersensitivity
• Immune System Diseases

Intervention

Dietary Supplement:
• Food proteins
Food proteins

Drug:
• Omalizumab
Drug

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events in the treatment population		2 years	Yes
Secondary	Number of subjects who reach 2g or more of food flour		2 years	Yes