Oral Immunotherapy (OIT) for Peanut Allergy

NCT00815035 | Completed Phase 2 Results DMC

• 1 other identifier: 11-2315
• Study Type: interventional
• Target: 16
• 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 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).

Conditions

Peanut Hypersensitivity

Keywords

Peanut Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The Percentage of Subjects Achieving Full Desensitization as Defined by a Negative DBPCFC After 60 Months of 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

  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

  approximately 40 weeks (10 months)

• Incidence of All Serious Adverse Events During the Study

  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.

Study Arms (2)

Peanut OIT

ACTIVE COMPARATOR

Subjects randomized to receive active treatment with peanut protein flour.

Drug: Peanut OIT

Placebo

PLACEBO COMPARATOR

Subjects randomized to receive placebo in the form of oat flour.

Drug: Placebo

Interventions

Peanut OIT DRUG

Peanut flour that is orally ingested in a graded fashion.

Also known as: Peanut flour

Peanut OIT

Placebo DRUG

Oat flour used as a placebo that is orally ingested a graded fashion

Also known as: Oat flour

Placebo

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

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 (2)

• 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.

  PMID: 12562461 BACKGROUND

• 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.

  PMID: 17208602 BACKGROUND

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

edwinkim@email.unc.edu

919-843-9087

Study Officials

• Wesley 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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2008
• First Posted: December 29, 2008
• Study Start: April 1, 2009
• Primary Completion: December 12, 2016
• Study Completion: December 12, 2016
• Last Updated: March 1, 2018
• Results First Posted: May 15, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)