Oral Immunotherapy (OIT) for Peanut Allergy (PnOIT3)

Oral Immunotherapy for Peanut Allergy- Peanut Oral Immunotherapy (PnOIT3)

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

Study Overview

• Status: Completed
• Conditions: Peanut Hypersensitivity
• Intervention / Treatment: Drug: Peanut OIT; Drug: Placebo

Detailed Description

Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies it tends to be more persistent and also 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 oral immunotherapy (OIT). We are also studying the effect of peanut OIT on the peanut specific immune response to determine if tolerance to peanut protein will develop. Children ages one to six years of age with peanut allergy will be randomized to peanut OIT or placebo (active subjects). Thirty subjects will also be recruited as controls. These subjects will not receive any peanut or placebo but only have skin prick testing and lab work in addition to a history and physical exam. Active subjects will undergo a modified rush immunotherapy on the first day and then increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at home except for dose increases which will be done on the research unit. Outcome variables of interest include response to double-blind placebo controlled food challenge, skin prick testing, peanut specific IgE, and adverse events. These results will be compared between the start and end of peanut OIT using appropriate statistical analysis.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 1- 6 years all of either sex, any race, any ethnicity at the time of the initial visit
• The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal >3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7 kUA/L
• A history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts
• Provide signed informed consent

Exclusion Criteria:

• History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or oxygen saturation < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
• 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
• Poor control or persistent activation of atopic dermatitis
• Moderate to severe persistent asthma
• 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 oral food challenges (OFCs)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Peanut OIT; Subjects randomized to receive active treatment with peanut protein flour.	Drug: Peanut OIT; Peanut flour that is orally ingested in a graded fashion.; Other Names: Peanut flour
Placebo Comparator: Placebo; Subjects randomized to receive placebo in the form of oat flour.	Drug: Placebo; Oat flour used as a placebo that is orally ingested a graded fashion; Other Names: Oat flour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Achieving Tolerance as Defined by a Negative DBPCFC 4 Weeks After Discontinuation of Peanut OIT Therapy.	Upon completion of 60 months of peanut OIT treatment, subjects discontinued peanut OIT for 4 weeks. The primary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms 4 weeks after discontinuing peanut OIT.	61 months for those randomized to active treatment and 73 months for those randomized to placebo for the initial 12 months of therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Subjects Achieving Full Desensitization as Defined by a Negative DBPCFC After 60 Months of Peanut OIT Therapy.	Upon completion of 60 months of peanut OIT treatment, subjects underwent a double-blind placebo controlled food challenge (DBPCPFC) to assess desensitization. The secondary clinical efficacy outcome of the study was the percentage of peanut allergic subjects who completed a 5 gm peanut protein double-blind placebo controlled food challenge (DBPCPFC) without developing symptoms after completing peanut OIT therapy.	60 months for those randomized to active treatment and 72 months for those randomized to placebo for the initial 12 months of therapy
The Percentage of Subjects Who Tolerated the Initial-day Escalation to 6 mg of Peanut	The first day of peanut OIT dosing involved multiple increasing doses of peanut flour in what was called an initial escalation day up to a maximum dose of 6 mg of peanut protein. The secondary outcome measure assessed the percentage of subjects were successfully able to reach this 6 mg dose.	first day of peanut OIT dosing
The Percentage of Subjects Who Are Successfully Able to Escalate up to the 4000 mg Maximum Maintenance Dose of Peanut Protein OIT During the 60 Month Desensitization Phase of the Study	During the desensitization phase of the study, subjects under go an initial day escalation up to a maximum of 6 mg of peanut protein. They then undergo biweekly dose escalation over approximately 10 months up to a maximum dose of 4000 mg of peanut protein. This outcome reports the percentage of subjects that achieve this.	approximately 40 weeks (10 months)
Incidence of All Serious Adverse Events During the Study	All serious adverse events during the blinded and open-label phases of the study were recorded and reported as a safety outcome.	61 months for those randomized to active peanut OIT and 73 months for those randomized to placebo for the initial 12 months of the study.

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Patriarca G, Nucera E, Roncallo C, Pollastrini E, Bartolozzi F, De Pasquale T, Buonomo A, Gasbarrini G, Di Campli C, Schiavino D. Oral desensitizing treatment in food allergy: clinical and immunological results. Aliment Pharmacol Ther. 2003 Feb;17(3):459-65. doi: 10.1046/j.1365-2036.2003.01468.x. Erratum In: Aliment Pharmacol Ther. 2003 May 1;17(9):1205.
• Buchanan AD, Green TD, Jones SM, Scurlock AM, Christie L, Althage KA, Steele PH, Pons L, Helm RM, Lee LA, Burks AW. Egg oral immunotherapy in nonanaphylactic children with egg allergy. J Allergy Clin Immunol. 2007 Jan;119(1):199-205. doi: 10.1016/j.jaci.2006.09.016. Epub 2006 Oct 27.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): December 12, 2016
• Study Completion (Actual): December 12, 2016

Study Registration Dates

• First Submitted: December 26, 2008
• First Submitted That Met QC Criteria: December 26, 2008
• First Posted (Estimate): December 29, 2008

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Peanut Allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Nut and Peanut Hypersensitivity; Hypersensitivity; Peanut Hypersensitivity
• Other Study ID Numbers: 11-2315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No