Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Peanut Oral Immunotherapy in Children (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01867671
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : January 22, 2020
Last Update Posted : March 16, 2020
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.

Condition or disease Intervention/treatment Phase
Peanut Hypersensitivity Biological: Peanut Oral Immunotherapy - Liquid Extract Biological: Placebo for Peanut Oral Immunotherapy - Liquid Extract form Biological: Peanut Oral Immunotherapy - Peanut Flour Biological: Placebo for Peanut Oral Immunotherapy - Peanut Flour Phase 2

Detailed Description:

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (ITN050AD)
Actual Study Start Date : August 13, 2013
Actual Primary Completion Date : July 2, 2018
Actual Study Completion Date : December 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Experimental: Peanut Oral Immune Therapy (OIT)
Peanut OIT for 134 weeks followed by peanut avoidance for 26 weeks.
Biological: Peanut Oral Immunotherapy - Liquid Extract
Used during initial dose escalation for doses 0.1 to 0.8 mg.

Biological: Peanut Oral Immunotherapy - Peanut Flour
This will be used for the remainder of dose escalation, build-up, and maintenance.

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.
Biological: Placebo for Peanut Oral Immunotherapy - Liquid Extract form
Similar in appearance, texture, and taste to peanut liquid extract.

Biological: Placebo for Peanut Oral Immunotherapy - Peanut Flour
Similar in appearance, texture, and taste to peanut flour.




Primary Outcome Measures :
  1. Percentage of Participants Desensitized to Peanut Protein After 134 Weeks of Oral Immunotherapy (OIT) [ Time Frame: Week 134 ]

    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.



Secondary Outcome Measures :
  1. Percentage of Tolerant Participants at Week 160 [ Time Frame: Week 160 ]
    Definition of Tolerant: A participant who passed the oral food challenge (OFC) to 10 grams of peanut flour (=5 grams of peanut protein).

  2. Count of Participants With Transient Desensitization [ Time Frame: Week 134, Week 160 ]
    Definition of transient desensitization: A participant who passed the blinded (masked) oral food challenge (OFC) to 10 grams peanut flour (=5 grams peanut protein) at week 134 and failed the week 160 in the Peanut oral immunotherapy (OIT) group.

  3. Highest Tolerated Cumulative Dose [ Time Frame: Week 160 ]

    The highest tolerated cumulative dose of peanut protein during the blinded (masked) oral food challenge (OFC) at Week 160, analyzed within and between both placebo and peanut OIT groups. The highest cumulative dose of peanut protein tolerated for each participant was analyzed as a continuous outcome.

    Any randomized participant without an evaluable blinded (masked) OFC was imputed as not tolerant. For the continuous highest cumulative dose endpoint, this is defined as having a highest cumulative dose imputed as zero.


  4. Percentage of Participants That Withdrew From the Study [ Time Frame: Initial Dose Escalation through Week 160 (Tolerance Assessment) ]
    Percentage of participants that withdrew from study participation, listed by study phase (at time of study withdrawal).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Months to 48 Months   (Child)
Sexes Eligible for Study:   All
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 ≥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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867671


Locations
Layout table for location information
United States, Arkansas
University of Arkansas for Medical Sciences: Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94040
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
UNC Chapel-Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Investigators
Layout table for investigator information
Study Chair: Wesley Burks, MD UNC Chapel-Hill
Study Chair: Stacie M. Jones, MD University of Arkansas
  Study Documents (Full-Text)

Documents provided by National Institute of Allergy and Infectious Diseases (NIAID):
Additional Information:
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01867671    
Other Study ID Numbers: DAIT ITN050AD
First Posted: June 4, 2013    Key Record Dates
Results First Posted: January 22, 2020
Last Update Posted: March 16, 2020
Last Verified: February 2020
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Allergy, Peanut
Peanut allergy
Hypersensitivity
Immunotherapy
Desensitization, Immunologic
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Immunologic Factors
Physiological Effects of Drugs