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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01274429
Study type	Interventional
Source	University of North Carolina, Chapel Hill
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	December 2010
Completion date	November 2015

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05667610` - Immune-supportive Diet and Gut Permeability in Allergic Children	N/A
Recruiting	`NCT05440643` - Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy	Phase 1
Terminated	`NCT03849079` - Validation of the HYPONUT Product	N/A
Completed	`NCT02979600` - Clinical and Biological Efficacy of Peanut Oral Immunotherapy	N/A
Completed	`NCT01955109` - Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children	Phase 2
Completed	`NCT01950533` - The Utility of Food-Specific IgE Measured With the IMMULITE 2000 Assay to Predict Symptomatic Food Allergy
Recruiting	`NCT04415593` - High and Low Dose Oral Peanut Immunotherapy - Comparison of Efficacy and Safety	N/A
Active, not recruiting	`NCT04511494` - Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT	N/A
Active, not recruiting	`NCT04887441` - Allergology: Information, Data and Knowledge Organization
Active, not recruiting	`NCT04881773` - Oral Low Doses Tolerance INduction Study for Peanuts
Completed	`NCT03682770` - Study in Pediatric Subjects With Peanut Allergy to Evaluate Efficacy and Safety of Dupilumab as Adjunct to AR101 (Peanut Oral Immunotherapy)	Phase 2
Terminated	`NCT03703791` - Real World, Open Label, QOL Assessment of Peanut Immunotherapy AR101 in Children and Adolescents	Phase 3
Completed	`NCT02916446` - Safety Study of Viaskin Peanut to Treat Peanut Allergy	Phase 3
Active, not recruiting	`NCT02402231` - Treatment of Severe Peanut Allergy With Xolair (Omalizumab) and Oral Immunotherapy	Phase 2
Completed	`NCT03337542` - AR101 Real-World Open-Label Extension Study	Phase 3
Recruiting	`NCT05476497` - Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects	Phase 1
Completed	`NCT03648320` - The Grown Up Peanut Immunotherapy Study	N/A
Completed	`NCT03292484` - Longer-term Study of AR101 in Subjects Who Participated in a Prior AR101 Study (ARC008)	Phase 3
Completed	`NCT03852342` - Reactive Doses and Times During Oral Food Challenge to Peanut
Recruiting	`NCT05138757` - Pinpoint Trial: Prebiotics IN Peanut Oral ImmunoTherapy	Phase 1/Phase 2