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

NCT00932828 | Completed Phase 2 Results DMC

• 1 other identifier: 11-2307
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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).

Conditions

Food Hypersensitivity

Keywords

Peanut allergy

Outcome Measures

Primary Outcomes (1)

• Determine the Percentage of Subjects Who Demonstrate Sustained Unresponsiveness (SU) by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC).

  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.

  After 36 months of OIT dosing followed by 1 month of avoidance

Secondary Outcomes (2)

• Determine the Percentage of Subjects Who Demonstrate Desensitization by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC).

  After 36 months of OIT dosing

• Determine the Frequency of Treatment-related Adverse Effects (TAE) From Peanut OIT.

  After 36 months of OIT dosing followed by 1 month of avoidance

Study Arms (1)

Peanut oral immunotherapy

EXPERIMENTAL

Newly diagnosed allergic children receiving peanut flour as oral immunotherapy for the treatment of peanut allergy.

Drug: Peanut oral immunotherapy

Interventions

Peanut oral immunotherapy DRUG

Defatted peanut in flour form to be used as treatment for peanut allergy

Also known as: Peanut mucosal immunotherapy, Peanut OIT

Peanut oral immunotherapy

Eligibility Criteria

• Age: 9 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Vickery BP, Berglund JP, Burk CM, Fine JP, Kim EH, Kim JI, Keet CA, Kulis M, Orgel KG, Guo R, Steele PH, Virkud YV, Ye P, Wright BL, Wood RA, Burks AW. Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective. J Allergy Clin Immunol. 2017 Jan;139(1):173-181.e8. doi: 10.1016/j.jaci.2016.05.027. Epub 2016 Aug 10.

  PMID: 27522159 RESULT

MeSH Terms

Conditions

Food Hypersensitivity; Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity

Results Point of Contact

• Title: Dr. Edwin Kim, Director of the UNC Food Allergy Initiative
• Organization: University of North Carolina at Chapel Hill

edwinkim@email.unc.edu

919-843-9087

Study Officials

• Arvil W Burks, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 3, 2009
• Study Start: June 22, 2009
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 24, 2018
• Results First Posted: May 24, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)