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History of Changes for Study: NCT01867671
Peanut Oral Immunotherapy in Children (IMPACT)
Latest version (submitted February 26, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 29, 2013 None (earliest Version on record)
2 August 2, 2013 Arms and Interventions, Contacts/Locations and Study Status
3 August 6, 2013 References and Study Status
4 June 12, 2014 Study Status and Contacts/Locations
5 May 22, 2015 Study Status and Contacts/Locations
6 June 4, 2015 Study Status
7 June 29, 2015 Study Description, Contacts/Locations, Eligibility and Study Status
8 November 5, 2015 Contacts/Locations, Study Status and Eligibility
9 November 9, 2015 Recruitment Status, Study Status, Contacts/Locations and Study Design
10 December 7, 2016 References, Study Status and Eligibility
11 December 27, 2017 Study Status and Contacts/Locations
12 June 1, 2018 Study Status
13 July 17, 2018 Study Status
14 September 26, 2018 Study Status
15 January 15, 2019 Recruitment Status, Study Status
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Results Submission Events
16 January 10, 2020 Outcome Measures, Study Status, More Information, Document Section, Adverse Events, Baseline Characteristics and Participant Flow
17 February 26, 2020 Outcome Measures and Study Status
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Study NCT01867671
Submitted Date:  May 29, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: DAIT ITN050AD
Brief Title: Peanut Oral Immunotherapy in Children (IMPACT)
Official Title: Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (ITN050AD)
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2013
Overall Status: Recruiting
Study Start: May 2013
Primary Completion: October 2015 [Anticipated]
Study Completion: October 2015 [Anticipated]
First Submitted: May 23, 2013
First Submitted that
Met QC Criteria:
May 29, 2013
First Posted: June 4, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 29, 2013
Last Update Posted: June 4, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Responsible Party: Sponsor
Collaborators: Immune Tolerance Network (ITN)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo. 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.

An initial oral food challenge (OFC) to 1 g of peanut flour (500 mg peanut protein) will be conducted. Participants must have a clinical reaction during this OFC to initiate study dosing. After the initial OFC, the study design includes four phases:

  • Initial dose escalation (1 day): Peanut or placebo dosing will be given incrementally and increase every 20 minutes until a dose of 12 mg peanut flour (6 mg peanut protein) or placebo flour is given.
  • Build-up (30 weeks): Initial observed dose administration of highest tolerated dose, followed by daily OIT at home with return visit every 2 weeks for dose escalation.
  • Maintenance (104 weeks):The participant will continue on daily OIT with return visits every 13 weeks. At the end of this phase the participant will undergo a blinded OFC to 10 g peanut flour (5 g peanut protein).
  • Avoidance (26 weeks): In this final phase participants will be seen every 13 weeks. At the completion of this phase participants will have a final blinded OFC to 10g peanut flour (5 g peanut protein).
Detailed Description:
Open or close this module Conditions
Conditions: Peanut Hypersensitivity
Keywords: Allergy, Peanut
Peanut allergy
Hypersensitivity
Immunotherapy
Desensitization, Immunologic
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 144 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Peanut Oral Immune Therapy (OIT)
Peanut OIT for 134 weeks followed by peanut avoidance for 26 weeks.
Biological: Peanut Oral Immunotherapy
There will be two forms of peanut oral immunotherapy. Both forms will be derived from the peanut flour source material. One form will be a liquid extract which will be used during initial dose escalation for doses 0.1 to 0.8 mg of peanut protein. Another form will be the peanut flour which will be used for the remainder of dose escalation, build-up and maintenance. Each form will have its own placebo.
Placebo Comparator: Peanut Placebo
Peanut placebo for 134 weeks followed by peanut avoidance for 26 weeks. The placebo extract will be derived from oat flour source material.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Proportion of Desensitized Subjects
[ Time Frame: week 134 ]

Participants who pass an oral food challenge (OFC) to 10 g of peanut flour (5 g of peanut protein) at this time without significant symptoms will be considered desensitized to peanut. Failure will be defined as either unable to undergo the final food challenge or inability to tolerate the maximum dose because of significant symptoms such as hives, wheezing, vomiting, or laryngeal edema.
Secondary Outcome Measures:
1. Tolerance Endpoint
[ Time Frame: week 160 ]

The proportion of participants who pass the OFC to 10 g peanut flour (5 g peanut protein).
2. Transient Desensitization
[ Time Frame: week 134 to week 160 ]

The change in proportion of participants who pass the OFC to 10 g peanut flour (5 g peanut protein)at week 134 and week 160.
3. Highest Tolerated Cumulative Dose
[ Time Frame: week 160 ]

The highest tolerated cumulative dose of peanut protein during the OFCs.
4. The incidence of all adverse events
[ Time Frame: week 160 ]

5. Rates of Withdrawal from OIT or Placebo
[ Time Frame: week 160 ]

Open or close this module Eligibility
Minimum Age: 12 Months
Maximum Age: 48 Months
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of severe anaphylaxis with hypotension to peanut
  • Documented clinical history of allergy to oat
  • Suspected allergy to oat and a wheal greater than or equal to 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
  • The presence of any medical condition that the investigator deems incompatible with participation in the trial
Open or close this module Contacts/Locations
Study Officials: Wesley Burks, MD
Study Chair
UNC Chapel-Hill
Stacie M. Jones, MD
Study Chair
University of Arkansas
Locations: United States, Arkansas
Univeristy of Arkansas for Medical Sciences: Arkansas Children's Hospital
[Not yet recruiting]
Little Rock, Arkansas, United States, 72202
Contact:Contact: Anne Hiegel 501-364-3755 hiegelannem@uams.edu
Contact:Principal Investigator: Stacie Jones, MD
United States, California
Stanford University School of Medicine
[Not yet recruiting]
Stanford, California, United States, 94040
Contact:Contact: Kyrsten Spann 650-724-0293 knspann@comcast.net
Contact:Principal Investigator: Kari Nadeau
United States, North Carolina
UNC Chapel-Hill
[Recruiting]
Chapel-Hill, North Carolina, United States, 27599
Contact:Contact: Corinne Barnes, MD 919-962-4406 cmbarnes@unc.edu
Contact:Principal Investigator: Wesley Burks, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: National Institute of Allergy and Infectious Diseases (NIAID)
Description: Immune Tolerance Network
Available IPD/Information:

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