Oral Immunotherapy for Peanut Allergy (PMIT)

NCT00597675 | Completed Phase 2 Results DMC

• 1 other identifier: Pro00000163
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects who have peanut allergy less allergic and induce changes in their immune system.

Conditions

Food Hypersensitivity

Keywords

Peanut allergy

Outcome Measures

Primary Outcomes (1)

• The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing Treatment With Peanut OIT.

  After completing the peanut OIT protocol (defined as treatment with peanut OIT for at least 36-months AND a peanut-specific IgE \>2 and \<15 AND skin prick test is \<5 mm OR a maximum of 60 months of treatment), the reaction threshold for subjects is assessed by a DBPCFC. This involves eating small increasing doses of peanut protein in a blinded fashion up to a cumulative total of 5000 mg. An identical food challenge is also performed with oat flour as a placebo. The cumulative amount of peanut protein ingested prior to the dose that causes a reaction requiring treatment is reported as the reaction threshold.

  36-60 months

Secondary Outcomes (4)

• The Amount of Peanut Protein Ingested Before An Allergic Reaction is Observed During the Double-blind, Placebo Controlled Food Challenge (DBPCFC) After Completing 12 Months of Blinded Peanut OIT or Placebo Treatment.

  12 months

• The Change From Baseline Through the End of Peanut OIT Treatment in Wheal Size Diameter Following Peanut Skin Prick Testing

  Baseline to end of open label phase treatment (36-60 months)

• The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgE in the Blood

  Baseline to end of open label phase treatment (36-60 months)

• The Change From Baseline Through the End of Peanut OIT Treatment in Peanut-specific IgG4 in the Blood.

  Baseline to end of open label phase treatment (36-60 months)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Oat flour ingested daily as a placebo

Biological: Placebo

Peanut OIT

ACTIVE COMPARATOR

Peanut flour ingested daily as oral mucosal immunotherapy

Biological: Peanut OIT

Interventions

Peanut OIT BIOLOGICAL

Defatted peanut flour ingested daily as oral mucosal immunotherapy

Peanut OIT

Placebo BIOLOGICAL

Oat flour matched by weight and consistency that is ingested daily as a placebo

Placebo

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subject between 1 and 18 years of age
• EITHER history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts greater than 6 months ago AND peanut specific IgE \>15 kU/L
• OR history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts within the past 6 months AND peanut specific IgE \> 7 kU/L
• A family that will be able to be compliant with all study visits
• All females of child bearing age must be using appropriate birth control

You may not qualify if:

• Subjects with a history of severe, anaphylaxis to peanut
• Medical history that would prevent a double blind placebo controlled oral food challenge (DBPCFC/OFC) to peanut
• Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
• Diagnosed oat allergy
• Pregnancy or lactation

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of Arkansas: collaborator

Study Sites (2)

University of Arkansas Medical Center

Little Rock, Arkansas, 72202, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

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, Chapel Hill

  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: January 4, 2008
• First Posted: January 18, 2008
• Study Start: March 1, 2007
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 27, 2018
• Results First Posted: May 3, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)