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

NCT01274429 | Terminated Phase 1 Results DMC

• 1 other identifier: 11-2314
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Peanut Allergy

Keywords

Peanut allergy; Immunotherapy; OIT

Outcome Measures

Primary Outcomes (1)

• Determine Whether This Peanut OIT Protocol Lowers Their Risk of Anaphylactic Reactions and Causes Long-term Tolerance.

  Assess mg of peanut tolerated on double-blind placebo-controlled food challenge as a measure of desensitization and tolerance

  2-3 years

Secondary Outcomes (1)

• Determine the Effect That PNOIT Has on the Peanut-specific Cellular and Humoral Response in Peanut-allergic Subjects.

  2-3 years

Study Arms (1)

Open label peanut flour

EXPERIMENTAL

Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.

Drug: Peanut flour

Interventions

Peanut flour DRUG

Peanut flour that is ingested daily and administered in gradually increasing amounts up to a maximum maintenance dose.

Also known as: Peanut OIT

Open label peanut flour

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Early termination due to lack of funding prior to any subjects reaching the primary endpoint.

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

• Wesley Burks, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2011
• First Posted: January 11, 2011
• Study Start: December 1, 2010
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 27, 2018
• Results First Posted: March 10, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)