Peanut Oral Immunotherapy (OIT) - Initial Pilot Study in Adults

Phase 1

Terminated

• Conditions: Peanut Allergy
• Interventions: Drug: Peanut flour

• Registration Number: NCT01274429
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The goal of this study is to produce a new treatment that would benefit adult subjects by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance). This project is designed to study the innovative idea that oral immunotherapy (OIT), the ingestion of small increasing amounts of food allergen, will desensitize subjects with peanut hypersensitivity by regulating their mucosal and systemic immune reactivity and cause long-term tolerance.

Detailed Description

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). This is a research study to test stimulation of the immune system to improve peanut allergy. The approach the investigators will use for peanut allergy is called desensitization. A person becomes desensitized to a food by taking small, increasing amounts of the food to help the body become used to the food so that it no longer causes a severe allergic reaction.

The study also looks at the safety and immune system effects of the investigational study product, peanut protein. The word "investigational" means the study product is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA).

This project is designed to study if peanut oral immunotherapy (POIT) will desensitize subjects with peanut hypersensitivity by regulating their oral and systemic immune reactivity and cause long-term tolerance.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-09
• Study First Submitted QC: 2011-01-10
• Study First Posted: 2011-01-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Results First Submitted: 2017-01-21
• Results First Submitted QC: 2017-01-21
• Status Verified: 2017-03
• Results First Posted: 2017-03-10
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Age 18 to 50 years of age of any gender, race, or ethnicity.
• Diagnosis of peanut allergy OR convincing clinical history of peanut allergy.
• Detectable serum peanut -specific Immune globin E(IgE) level (CAP-FEIA ≥ 0.35 kU/L) and a positive skin prick test (SPT) to peanut.
• Participant willing to use effective method of contraception if female for the duration of the study, not pregnant or lactating, and not planning to become pregnant.
• Positive reaction to ≤ 2 gm peanut protein on entry challenge.

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Exclusion Criteria

• History of severe anaphylaxis to peanut per current National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) allergic reaction toxicity grading.
• Known sensitivity or intolerance to Oats.
• FEV1 value <80% predicted or any clinical features of moderate or persistent asthma per 2007 National Heart Lung and Blood Institute (NHLBI) guidelines.
• Exacerbation of asthma in the past year requiring hospitalization or greater than 1 emergency department (ED) visit for asthma in the past 6 months.
• Use Beta-blockers, ACE inhibitors, angiotensin receptor blocker (ARB) , or calcium channel blockers, xolair, or immunological treatments.
• Uncontrolled hypertension per JNC 7 Guidelines (BP > 145/95 seated readings on each of two or more office visits).
• Active eosinophilic gastrointestinal disease which could be exacerbated by peanut oral immunotherapy.
• Chronic diseases such as diabetes, liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, blood disorders, or history of ischemic cardiovascular disease, or other conditions that in the opinion of the Investigator make the subject unsuitable for induction of food allergy reactions.
• Unable to speak English.
• Inability to discontinue antihistamines prior to food challenges and skin prick tests.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open label peanut flour	Peanut flour	Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.

Primary Outcome Measures

Name	Time	Method
Determine Whether This Peanut OIT Protocol Lowers Their Risk of Anaphylactic Reactions and Causes Long-term Tolerance.	2-3 years	Assess mg of peanut tolerated on double-blind placebo-controlled food challenge as a measure of desensitization and tolerance

Secondary Outcome Measures

Name	Time	Method
Determine the Effect That PNOIT Has on the Peanut-specific Cellular and Humoral Response in Peanut-allergic Subjects.	2-3 years	Measure changes over the course of treatment in serum specific IgE and IgG4, skin prick tests, TH1 and TH2 cytokines, and CD4+ CD25+ FoxP3+ regulatory T cells

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States