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The Peanut Oral Immunotherapy Study: Safety, Efficacy and Discovery

NCT02103270 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-09-04

Study results available
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Summary

Determine whether peanut oral immunotherapy (OIT) induces clinical tolerance as assessed after the initial 3 month avoidance period

Secondary Objectives:

* Identify the basic immune mechanisms which can explain the differences in the effects of OIT in desensitized vs. tolerant individuals.
* Determine whether immune monitoring measurements reflecting underlying mechanisms during OIT can be used to predict responses to OIT in individual subjects and, ultimately, to improve the safety and efficacy outcomes in peanut OIT protocols.

Conditions

Interventions

DRUG

Peanut Protein 4,000mg

Arm A will be defined as "clinically tolerant" if there is no clinical reactivity at the Week 104 and Week 117 DBPCFC. Clinical reactivity is defined as any reaction ≥ Grade 1 based on the Bock's Criteria (Appendix 4). Individuals in Arm A who meet the definition of "clinically tolerant" will continue to avoid peanut protein (i.e. continue on 600 mg per day of oat flour) as long as each subsequent DBPCFC (performed every 13 weeks until end of study) shows no clinical reactivity.

DRUG

Oat Flour

Arm C will be defined as "natural loss of responsiveness" if they show no clinical reactivity at DBPCFCs (week 117 to end of study).

DRUG

Peanut Protein 300 mg

Arm B will be defined as "desensitized" to a minimum of 300 mg per day of peanut protein if they show no clinical reactivity at DBPCFCs (week 117 to end of study).

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Stanford University

    lead OTHER

Principal Investigators

  • Kari C Nadeau, MD PhD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2018-07-25
Completion
2018-09-01

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02103270 on ClinicalTrials.gov