NCT01867671

Brief Summary

This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

August 13, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 22, 2020

Completed
Last Updated

March 16, 2020

Status Verified

February 1, 2020

Enrollment Period

4.9 years

First QC Date

May 23, 2013

Results QC Date

December 20, 2019

Last Update Submit

February 26, 2020

Conditions

Peanut Hypersensitivity

Keywords

Allergy, PeanutPeanut allergyHypersensitivityImmunotherapyDesensitization, Immunologic

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT)

    Definition of desensitized to peanut: A participant who passed the blinded (masked) oral food challenge (OFC) to10 grams of peanut flour (=5 grams of peanut protein) without significant symptoms.\* \*Significant symptoms include hives, wheezing, vomiting, or laryngeal edema.

    Week 134

Secondary Outcomes (4)

  • Percentage of Tolerant Participants at Week 160

    Week 160

  • Count of Participants With Transient Desensitization

    Week 134, Week 160

  • Highest Tolerated Cumulative Dose

    Week 160

  • Percentage of Participants That Withdrew From the Study

    Initial Dose Escalation through Week 160 (Tolerance Assessment)

Study Arms (2)

Peanut Oral Immune Therapy (OIT)

EXPERIMENTAL

Peanut OIT for 134 weeks followed by peanut avoidance for 26 weeks.

Biological: Peanut Oral Immunotherapy - Liquid ExtractBiological: Peanut Oral Immunotherapy - Peanut Flour

Peanut Placebo

PLACEBO COMPARATOR

Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. The placebo extract will be derived from oat flour source material.

Biological: Placebo for Peanut Oral Immunotherapy - Liquid Extract formBiological: Placebo for Peanut Oral Immunotherapy - Peanut Flour

Interventions

Peanut Oral Immunotherapy - Liquid ExtractBIOLOGICAL

Used during initial dose escalation for doses 0.1 to 0.8 mg.

Peanut Oral Immune Therapy (OIT)
Placebo for Peanut Oral Immunotherapy - Liquid Extract formBIOLOGICAL

Similar in appearance, texture, and taste to peanut liquid extract.

Peanut Placebo
Peanut Oral Immunotherapy - Peanut FlourBIOLOGICAL

This will be used for the remainder of dose escalation, build-up, and maintenance.

Peanut Oral Immune Therapy (OIT)
Placebo for Peanut Oral Immunotherapy - Peanut FlourBIOLOGICAL

Similar in appearance, texture, and taste to peanut flour.

Peanut Placebo

Eligibility Criteria

Age12 Months - 48 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical history of peanut allergy or avoidance of peanut without ever having eaten peanut;
  • Serum immunoglobulin E (IgE) to peanut of ≥5 kUA/L determined by UniCAP™, an in-vitro test system for diagnosis and monitoring of allergy and inflammation;
  • Wheal ≥ 3mm on skin prick test to peanut extract compared to a negative control;
  • A clinical reaction at or below ingestion of 1 g peanut flour (500 mg peanut protein) during screening OFC;
  • Written informed consent from parent/guardian.

You may not qualify if:

  • History of severe anaphylaxis with hypotension to peanut;
  • Documented clinical history of allergy to oat;
  • Suspected allergy to oat and a wheal ≥7mm on skin prick test to oat extract compared to a negative control;
  • Chronic disease other than asthma, atopic dermatitis, rhinitis requiring therapy; e.g., heart disease or diabetes;
  • Active eosinophilic gastrointestinal disease in the past 2 years;
  • Participation in any interventional study for the treatment of food allergy in the 6 months prior to visit -1;
  • Inhalant allergen immunotherapy that has not yet reached maintenance dosing;
  • Severe asthma, as indicated by repeated hospitalizations or hospital emergency department visits;
  • Moderate asthma defined according to National Asthma Education and Prevention Program Expert;
  • Panel that requires more than fluticasone 440 mcg or its equivalent daily for adequate control;
  • Inability to discontinue antihistamines for skin testing, OFC and the initial dose escalation;
  • Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) in the 12 months prior to visit -1;
  • Any systemic therapy which in the judgment of the investigator could be immunomodulatory (e.g. rituximab) in the 12 months prior to visit -1, systemic corticosteroid therapy of up to a total of three weeks is allowed;
  • Use of any investigational drug in 90 days prior to visit -1;
  • Plan to use any investigational drug during the study period;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Arkansas for Medical Sciences: Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Stanford University School of Medicine

Stanford, California, 94040, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

UNC Chapel-Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

MeSH Terms

Conditions

Peanut HypersensitivityHypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut HypersensitivityFood HypersensitivityHypersensitivity, ImmediateImmune System Diseases

Results Point of Contact

Title
Director, Clinical Research Operations Program
Organization
DAIT/NIAID
DAITClinicalTrialsGov@niaid.nih.gov
301-594-7669

Study Officials

  • Wesley Burks, MD

    UNC Chapel-Hill

    STUDY CHAIR

  • Stacie M. Jones, MD

    University of Arkansas

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
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
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2013

First Posted

June 4, 2013

Study Start

August 13, 2013

Primary Completion

July 2, 2018

Study Completion

December 21, 2018

Last Updated

March 16, 2020

Results First Posted

January 22, 2020

Record last verified: 2020-02

Locations

US(5)