Back to resultsMechanisms of Desensitization During Peanut Oral Immunotherapy (PnOIT4)
Primary Purpose
Food Hypersensitivity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Open label peanut OIT
Sponsored by
About this trial
This is an interventional other trial for Food Hypersensitivity focused on measuring Peanut allergy
Eligibility Criteria
Inclusion Criteria:
- Age 4 to up to 12 years of age of any gender, race, or ethnicity.
- Minimum weight 16 kg at the time of enrollment.
- Physician diagnosis of peanut allergy OR convincing clinical history of an allergic reaction to peanut.
- Detectable serum peanut -specific IgE level (CAP-FEIA ≥ 0.35 kU/L) and a positive SPT (wheal ≥ 3mm on skin prick test to peanut extract compared to a negative control.)
- Allergic reaction to ≤ 1 gm peanut protein during a blinded oral challenge test conducted at screening (e.g., a double-blinded, placebo-controlled food challenge [DBPCFC]).
- Written informed consent from parent/guardian.
- Written assent from subject if applicable
- Consumption of oat-containing product within 90 days prior to enrollment
Exclusion Criteria:
- History of allergic reaction to peanut consistent with severe anaphylaxis (defined as hypotension/shock; or neurologic impairment).
- Chronic disease other than asthma, atopic dermatitis, rhinitis requiring therapy; e.g., heart disease or diabetes.
- Active eosinophilic gastrointestinal disease in the past 2 years
- Participation in any interventional study for the treatment of food allergy in the 6 months prior to visit -1
- Inhalant allergen immunotherapy that has not yet reached maintenance dosing.
- Asthma defined as moderate or severe persistent by National Asthma Education and Prevention Program Expert Panel Guidelines (e.g. asthma that requires more than fluticasone 440 mcg or its equivalent daily for adequate control).
- Inability to discontinue antihistamines for skin testing, OFC and the initial dose escalation.
- Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) in the 12 months prior to visit -1.
- Any systemic therapy which in the judgment of the investigator could be immunomodulatory (e.g. rituximab) in the 12 months prior to visit -1, Systemic corticosteroid therapy of up to a total of three weeks is allowed.
- Use of investigational drug in 90 days prior to visit -1.
- Plan to use any investigational drug during the study period.
- The presence of any medical condition that the investigator deems incompatible with participation in the trial.
- Inability to speak English.
Sites / Locations
- UNC Chapel Hill
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open label peanut OIT
Arm Description
Open label orally ingested peanut flour with maintenance dose of 1450mg
Outcomes
Primary Outcome Measures
Percentage of Subjects Who Develop Desensitization
The percentage of peanut allergic subjects who develop desensitization as defined by being able to consume 5000mg of peanut protein during a double blind food challenge after completing a build-up phase of peanut OIT.
Secondary Outcome Measures
Percentage of Subjects Who Maintain Desensitization Once OIT is Stopped
The percentage of subjects who maintain desensitization once the OIT is withdrawn at 1, 2, 3, and 4 week intervals.
Full Information
NCT ID
NCT01814241
First Posted
March 15, 2013
Last Updated
February 27, 2018
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT01814241
Brief Title
Mechanisms of Desensitization During Peanut Oral Immunotherapy
Acronym
PnOIT4
Official Title
Mechanisms of Desensitization During Peanut Oral Immunotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to attempt to understand how desensitization works in peanut allergic children who are undergoing oral immunotherapy (OIT) to peanut. We want to identify the early changes in the desensitization process the immune cells undergo to become desensitized to the peanut protein.
Detailed Description
Peanut allergic children will undergo an oral food challenge (OFC) to 1 gm peanut protein in order to accomplish two objectives: (1)to confirm the diagnosis of peanut allergy, and (2) to measure the amount of peanut protein it takes to cause an allergic reaction. Each subject will then undergo a modified rush phase in which the subject receives 6 doses of peanut protein in one day. The build-up phase begins afterward in which the subject's dose of peanut protein is increased every 2 weeks for 36 weeks. After the final build-up dose, the subject consumes that dose for 2 weeks after which he or she returns to the food allergy center for the second food challenge. If the subject successfully consumes this food challenge without symptoms, the daily dosing of peanut protein will be stopped and the subject will then undergo a third food challenge. If the subject successfully consumes the peanut protein during that challenge, he or she will return for a fourth food challenge to peanut.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Hypersensitivity
Keywords
Peanut allergy
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open label peanut OIT
Arm Type
Experimental
Arm Description
Open label orally ingested peanut flour with maintenance dose of 1450mg
Intervention Type
Drug
Intervention Name(s)
Open label peanut OIT
Other Intervention Name(s)
Peanut flour
Intervention Description
Subject will take increasing amounts of peanut protein up to a maximum maintenace dose of 1450mg.
Primary Outcome Measure Information:
Title
Percentage of Subjects Who Develop Desensitization
Description
The percentage of peanut allergic subjects who develop desensitization as defined by being able to consume 5000mg of peanut protein during a double blind food challenge after completing a build-up phase of peanut OIT.
Time Frame
40 weeks
Secondary Outcome Measure Information:
Title
Percentage of Subjects Who Maintain Desensitization Once OIT is Stopped
Description
The percentage of subjects who maintain desensitization once the OIT is withdrawn at 1, 2, 3, and 4 week intervals.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Change From Baseline in the Wheal Diameter, as Assessed by the Skin Prick Test (SPT) to Peanut
Description
Allergic reactivity of mast cells is assessed by skin prick testing through measurement of the wheal diameter after exposure to peanut. This outcome measure reports the change in skin prick test wheal diameter from baseline through the end of the treatment period.
Time Frame
44 weeks
Title
Change in Peanut Specific Immunoglobin E (IgE) From Baseline Until Desensitization Food Challenge
Description
The investigation of mechanistic changes that occur in the immune system over the duration of the study - Peanut specific immunoglobin E (IgE)
Time Frame
44 weeks
Title
Change in Immunoglobin G4 (IgG4) to Peanut From Baseline Until Desensitization Food Challenge
Description
The investigation of mechanistic changes that occur in the immune system dover the duration of the study - Immunoglobin G4 (IgG4) to peanut
Time Frame
44 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 4 to up to 12 years of age of any gender, race, or ethnicity.
Minimum weight 16 kg at the time of enrollment.
Physician diagnosis of peanut allergy OR convincing clinical history of an allergic reaction to peanut.
Detectable serum peanut -specific IgE level (CAP-FEIA ≥ 0.35 kU/L) and a positive SPT (wheal ≥ 3mm on skin prick test to peanut extract compared to a negative control.)
Allergic reaction to ≤ 1 gm peanut protein during a blinded oral challenge test conducted at screening (e.g., a double-blinded, placebo-controlled food challenge [DBPCFC]).
Written informed consent from parent/guardian.
Written assent from subject if applicable
Consumption of oat-containing product within 90 days prior to enrollment
Exclusion Criteria:
History of allergic reaction to peanut consistent with severe anaphylaxis (defined as hypotension/shock; or neurologic impairment).
Chronic disease other than asthma, atopic dermatitis, rhinitis requiring therapy; e.g., heart disease or diabetes.
Active eosinophilic gastrointestinal disease in the past 2 years
Participation in any interventional study for the treatment of food allergy in the 6 months prior to visit -1
Inhalant allergen immunotherapy that has not yet reached maintenance dosing.
Asthma defined as moderate or severe persistent by National Asthma Education and Prevention Program Expert Panel Guidelines (e.g. asthma that requires more than fluticasone 440 mcg or its equivalent daily for adequate control).
Inability to discontinue antihistamines for skin testing, OFC and the initial dose escalation.
Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) in the 12 months prior to visit -1.
Any systemic therapy which in the judgment of the investigator could be immunomodulatory (e.g. rituximab) in the 12 months prior to visit -1, Systemic corticosteroid therapy of up to a total of three weeks is allowed.
Use of investigational drug in 90 days prior to visit -1.
Plan to use any investigational drug during the study period.
The presence of any medical condition that the investigator deems incompatible with participation in the trial.
Inability to speak English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesley Burks, MD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edwin Kim, MD
Organizational Affiliation
UNC Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Mechanisms of Desensitization During Peanut Oral Immunotherapy
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