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Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study (DEVIL)

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ClinicalTrials.gov Identifier: NCT00932828
Recruitment Status : Completed
First Posted : July 3, 2009
Results First Posted : May 24, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit young subjects who have recently been diagnosed with peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).

Condition or disease Intervention/treatment Phase
Food Hypersensitivity Drug: Peanut oral immunotherapy Phase 2

Detailed Description:
Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies, it tends to be more persistent and its prevalence seems to be rising. Currently, there is no proven treatment other than strict avoidance. We are attempting to decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut mucosal immunotherapy (PMIT) more commonly called oral immunotherapy (OIT). We are also studying the effect of PMIT on the peanut-specific immune response to determine if tolerance to peanut protein will develop. Based on our preliminary work and recent studies supporting the importance of early oral exposure in tolerance induction, we propose that early treatment of peanut allergy with PMIT will be safe and effective. Children ages 9 to 36 months with peanut allergy will be randomized to receive high or low dose PMIT using peanut flour. Subjects will undergo desensitization on the first day and then increase the doses gradually to a maintenance dose. Doses will be taken daily at home except for dose increases which will be done on the research unit. Subjects will undergo a double-blinded, placebo-controlled food challenge (DBPCFC) if challenge criteria are met. Subjects passing the first challenge will stop PMIT and repeat the DBPCFC to assess tolerance. Outcome variables of interest include response to oral food challenges (OFC), skin prick testing, peanut specific serum immunoglobin E (IgE), immunoglobin G (IgG), and immunoglobin G4 (IgG4) and stool immunoglobin A (IgA), T and B cell responses, quality of life, and adverse events. As secondary and exploratory outcomes, these longitudinal results will be compared between high and low dose PMIT groups and controls using appropriate statistical analysis.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Intervention Model Description: For the purposes of the primary outcome, all subjects will receive peanut OIT and represent a single group. For exploratory analysis, subjects will be randomized to high and low dose OIT to potentially look for a dose response.
Masking: None (Open Label)
Masking Description: For exploratory analysis, subjects will be randomized 1:1 to high (3000mg) and low dose (300mg) OIT to potentially look for a dose response. Low dose will be masked by adding oat flour to provide a dose equal to high dose with respect to flour but with lower peanut protein content
Primary Purpose: Treatment
Official Title: Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study; Grant "Optimizing Tolerance Induction in Peanut Allergy: The DEVIL Study"
Actual Study Start Date : June 22, 2009
Actual Primary Completion Date : February 1, 2017
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Peanut oral immunotherapy
Newly diagnosed allergic children receiving peanut flour as oral immunotherapy for the treatment of peanut allergy.
Drug: Peanut oral immunotherapy
Defatted peanut in flour form to be used as treatment for peanut allergy
Other Names:
  • Peanut mucosal immunotherapy
  • Peanut OIT



Primary Outcome Measures :
  1. Determine the Percentage of Subjects Who Demonstrate Sustained Unresponsiveness (SU) by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC). [ Time Frame: After 36 months of OIT dosing followed by 1 month of avoidance ]
    The goal of the study is to treat peanut-allergic subjects with peanut OIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes SU. We expect to demonstrate the effectiveness of peanut OIT in inducing SU by showing that subjects will have a negative DBPCFC to 5 grams of peanut following completion of a 36-month course of peanut OIT followed by avoidance of therapy for 4 weeks.


Secondary Outcome Measures :
  1. Determine the Percentage of Subjects Who Demonstrate Desensitization by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC). [ Time Frame: After 36 months of OIT dosing ]
    We expect to demonstrate the effectiveness of peanut OIT in inducing desensitization by showing that subjects will have a negative DBPCFC to 5 grams of peanut following completion of a 36-month course of peanut OIT .

  2. Determine the Frequency of Treatment-related Adverse Effects (TAE) From Peanut OIT. [ Time Frame: After 36 months of OIT dosing followed by 1 month of avoidance ]
    In addition to studying the effectiveness of peanut OIT, we will also determine the safety of peanut OIT by reporting the average rate of TAEs per person per dose.



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Ages Eligible for Study:   9 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 9-36 months of either sex, any race, any ethnicity at the time of the initial visit
  • EITHER a positive skin prick test to peanuts or in vitro [CAP-FEIA] peanut immunoglobin E (IgE) level in the blood > 0.35 kU/L PLUS a history of a clinical allergic reaction (defined as significant clinical symptoms occurring within 60 minutes after ingesting peanuts) within 6 months of screening
  • OR a positive prick skin test to peanuts and in vitro [CAP-FEIA] peanut IgE level > 5 kU/L when there is no history of allergic reaction and no known peanut exposure
  • Provision of signed informed consent
  • Development of symptoms characteristic of IgE-mediated food allergy (urticaria, angioedema, respiratory distress/wheeze/cough, vomiting/diarrhea, anaphylaxis) during initial oral food challenge

Exclusion Criteria:

  • History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise
  • Currently participating in a study using an investigational new drug
  • Participation in any interventional study for the treatment of food allergy in the past 12 months
  • Subjects with a known wheat food allergy will be excluded because of cross contamination of oat with wheat
  • Severe atopic dermatitis
  • Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI) guidelines
  • Inability to discontinue antihistamines for skin testing and OFCs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932828


Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Arvil W Burks, MD University of North Carolina
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:
Study Protocol  [PDF] April 8, 2013
Statistical Analysis Plan  [PDF] April 8, 2013


Publications of Results:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00932828     History of Changes
Other Study ID Numbers: 11-2307
First Posted: July 3, 2009    Key Record Dates
Results First Posted: May 24, 2018
Last Update Posted: May 24, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of North Carolina, Chapel Hill:
Peanut allergy

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate