Peanut Oral Immunotherapy in Children (IMPACT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01867671
First received: May 23, 2013
Last updated: November 9, 2015
Last verified: November 2015
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (ITN050AD)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Proportion of Desensitized Subjects [ Time Frame: week 134 ] [ Designated as safety issue: No ]
    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:
  • Tolerance Endpoint [ Time Frame: week 160 ] [ Designated as safety issue: No ]
    The proportion of participants who pass the OFC to 10 g peanut flour (5 g peanut protein).

  • Transient Desensitization [ Time Frame: week 134 to week 160 ] [ Designated as safety issue: No ]
    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.

  • Highest Tolerated Cumulative Dose [ Time Frame: week 160 ] [ Designated as safety issue: No ]
    The highest tolerated cumulative dose of peanut protein during the OFCs.

  • The incidence of all adverse events [ Time Frame: week 160 ] [ Designated as safety issue: Yes ]
  • Rates of Withdrawal from OIT or Placebo [ Time Frame: week 160 ] [ Designated as safety issue: No ]

Enrollment: 146
Study Start Date: August 2013
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
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 - 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.

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).
  Eligibility

Ages Eligible for Study:   12 Months to 48 Months   (Child)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01867671

Locations
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
Study Chair: Wesley Burks, MD UNC Chapel-Hill
Study Chair: Stacie M. Jones, MD University of Arkansas
  More Information

Additional Information:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01867671     History of Changes
Other Study ID Numbers: DAIT ITN050AD 
Study First Received: May 23, 2013
Last Updated: November 9, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Allergy, Peanut
Peanut allergy
Hypersensitivity
Immunotherapy
Desensitization, Immunologic

Additional relevant MeSH terms:
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 27, 2016