Back to resultsOmalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center
Primary Purpose
Immune System Diseases
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Food proteins
Omalizumab
Sponsored by
About this trial
This is an interventional treatment trial for Immune System Diseases focused on measuring Multiple food allergies
Eligibility Criteria
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.
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
One
Arm Description
Outcomes
Primary Outcome Measures
Number of adverse events in the treatment population
Secondary Outcome Measures
Number of subjects who reach 2g or more of food flour
Full Information
NCT ID
NCT01510626
First Posted
November 29, 2011
Last Updated
December 9, 2015
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT01510626
Brief Title
Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center
Official Title
Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune System Diseases
Keywords
Multiple food allergies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Food proteins
Intervention Description
Food proteins
Intervention Type
Drug
Intervention Name(s)
Omalizumab
Intervention Description
Drug
Primary Outcome Measure Information:
Title
Number of adverse events in the treatment population
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of subjects who reach 2g or more of food flour
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29296107
Citation
Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Observational long-term follow-up study of rapid food oral immunotherapy with omalizumab. Allergy Asthma Clin Immunol. 2017 Dec 21;13:51. doi: 10.1186/s13223-017-0223-8. eCollection 2017.
Results Reference
derived
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Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center
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