Peanut Epicutaneous Immunotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Consortium of Food Allergy Research
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01904604
First received: July 15, 2013
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

Food allergy happens when the immune system reacts against foods. The immune system is the part of the body that protects us from illness and germs, but it can also cause allergies. Peanut allergy occurs in 1 - 2% of people in the United States and other Western countries. There is proof that allergy to peanut is increasing. Allergic reactions to peanut can be severe and life threatening. The only way that you can prevent an allergic reaction is to avoid exposure to peanuts. However, peanut proteins are found in a variety of foods and people can be accidently exposed to peanut proteins. Treatment for accidental exposure include antihistamines (medications like Benadryl), and injectable epinephrine (adrenalin) which must be carried at all times. DBV Technologies has developed an epicutaneous delivery system, a patch that puts the peanut protein on the skin. The study will try to find out if peanut epicutaneous immunotherapy can protect people who are allergic to peanuts from having severe allergic reactions, when accidentally exposed to peanuts. The study also looks at the safety of the treatment and the effects it has on the immune system.


Condition Intervention Phase
Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Biological: 250 microgram (mcg) DBV712 Viaskin Patch
Biological: 100 microgram DBV712 Viaskin Patch
Biological: Placebo Viaskin Patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Epicutaneous Immunotherapy (EPIT) for Peanut Allergy: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study in Children and Adults (DAIT COFAR6)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percent of subjects desensitized to peanut protein [ Time Frame: after 52 weeks of therapy ] [ Designated as safety issue: No ]
    Desensitization is defined as a subject who can consume a cumulative dose of peanut protein equal to or greater than 5044 mg or at least a 10-fold increase, when compared to the dose received at the baseline oral food challenge (OFC).


Secondary Outcome Measures:
  • Percent of subjects desensitized to peanut protein [ Time Frame: after 30 months of therapy (week 130) ] [ Designated as safety issue: No ]

    Desensitization is defined based on the starting OFC threshold as follows:

    1. Those who successfully consumed (without dose-limiting symptoms) a cumulative dose of 0-44 mg of peanut protein at baseline must successfully consume a cumulative dose of at least 444 mg of peanut protein at the 30 month OFC;
    2. Those who successfully consume a cumulative dose of greater than 44 mg to less than 444 mg of peanut protein at baseline must successfully consume at least a 10-fold increase in peanut protein at the 30 month OFC;
    3. Those who successfully consume a cumulative dose of ≥444 mg of peanut protein at baseline must successfully consume at least 5,044 mg of peanut protein at the 30 month OFC.

  • Percent of subjects who can successfully consume two different cumulative doses of peanut protein without dose-limiting symptoms [ Time Frame: after 30 months of therapy (week 130) ] [ Designated as safety issue: No ]
    Dose levels of 1044 mg and 5044 mg of peanut protein.

  • Percent of desensitized subjects by dose level [ Time Frame: after 52 weeks of therapy ] [ Designated as safety issue: No ]
    Desensitization will be defined by sucessful OFCs for subjects on the higher-dose DBV712 Viaskin patch and those on the lower-dose DBV712 Viaskin patch.

  • Percent of desensitized subjects as measured by successful 5044 mg peanut protein OFC. [ Time Frame: after 52 weeks of therapy ] [ Designated as safety issue: No ]
  • Number of all adverse events related to therapy [ Time Frame: Baseline to 30 months of therapy (week 130) ] [ Designated as safety issue: Yes ]
  • Number of adverse events in subjects receiving the higher-dose DBV712 Viaskin patch, compared to those in the placebo group [ Time Frame: after 30 months of therapy (week 130) ] [ Designated as safety issue: Yes ]
  • Number of adverse events in subjects receiving the lower-dose DBV712 Viaskin patch doses compared to the placebo group [ Time Frame: after 30 months of therapy (week 130) ] [ Designated as safety issue: Yes ]
  • Percentage of subjects who pass an OFC to 5044 mg of peanut protein [ Time Frame: after 8 weeks and 20 weeks of discontinuation of dosing ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: September 2013
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-dose DBV712 Viaskin Patch
Active subjects who fail the 5044 mg peanut protein OFC at 52 weeks and those who fail the off-therapy OFC at 60 or 72 weeks, will continue on active treatment dosing through 30 months (130 weeks). At the end of study, all subjects on active therapy will undergo a 5044 mg peanut protein OFC on treatment; those who pass the 5044 mg peanut protein OFC will discontinue treatment for 8 weeks and then an additional 12 weeks, for a total of 20 weeks, to assess for sustained unresponsiveness. Subjects demonstrating sustained unresponsiveness will have follow up for 6 months. Active subjects who fail the 5044 mg peanut protein OFC at the following time points: 130 weeks, 138 weeks or at 150 weeks will be given dietary advice and will have follow-up for 3 months.
Biological: 250 microgram (mcg) DBV712 Viaskin Patch
250mcg dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours
Experimental: Low-dose DBV712 Viaskin Patch
Active subjects who fail the 5044 mg peanut protein OFC at 52 weeks and those who fail the off-therapy OFC at 60 or 72 weeks, will continue on active treatment dosing through 30 months (130 weeks). At the end of study, all subjects on active therapy will undergo a 5044 mg peanut protein OFC on treatment; those who pass the 5044 mg peanut protein OFC will discontinue treatment for 8 weeks and 20 weeks, to assess for sustained unresponsiveness. These subjects will be discontinued from further study therapy and will have follow up for 6 months. Active subjects who fail the 5044 mg peanut protein OFC at the following time points: 130 weeks, 138 weeks or at 150 weeks will be given dietary advice and will have follow-up for 3 months.
Biological: 100 microgram DBV712 Viaskin Patch
100 mcg dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours
Placebo Comparator: Placebo Viaskin Patch
Placebo-treated subjects who do not pass the 5044 mg peanut protein OFC at week 52 will cross-over to active treatment at a dose of 250 mcg for a total of 30 months (130 weeks) of active therapy. Placebo subjects who pass the week 52, 5044 mg peanut protein OFC will have an open feeding of 2 tablespoons of peanut butter and if passed, will be instructed to add peanut to their diet. These subjects will be discontinued from further study therapy and will have follow up for 6 months.
Biological: Placebo Viaskin Patch

  Eligibility

Ages Eligible for Study:   4 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Physician-diagnosed peanut allergy OR convincing history of peanut allergy.
  • A skin prick test positive to peanut (wheal diameter ≥3mm greater than the saline control) OR detectable peanut specific Immunoglobulin E (IgE) (ImmunoCAP >0.35 kUA/L)
  • Positive reaction to a cumulative dose of ≤1044 mg peanut protein in the initial qualifying Oral Food Challenge (OFC)
  • Use of an effective method of contraception by females of childbearing potential to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of their participation in the study
  • Ability to perform spirometry maneuvers in accordance with the American Thoracic Society (ATS) guidelines (1994). Children ages 4-11 years who have documented inability to adequately perform spirometry may be enrolled if Peak Expiratory Flow (PEF) is >80% of predicted
  • Provide signed informed consent or assent where indicated

Exclusion Criteria:

  • History of anaphylaxis to peanut resulting in hypotension, neurological compromise or requiring mechanical ventilation
  • Participation in a study using an investigational new drug in the last 30 days
  • Participation in any interventional study for the treatment of food allergy in the past 6 months
  • Pregnancy or lactation
  • Current or known allergy to the Viaskin Peanut/Placebo patch device or excipients
  • Current or known allergy to the placebo allergen (oat flour)
  • Currently in a build-up phase of any allergen immunotherapy
  • Severe or poorly controlled atopic dermatitis or greater than a mild flare of active disease at enrollment
  • Forced Expiratory Volume in 1 Second (FEV1) value <80% predicted or any clinical features of moderate or severe persistent asthma baseline severity (as defined by the 2007 NHLBI Guidelines) and greater than high daily doses of inhaled corticosteroids (>500mcg of Fluticasone or equivalent)
  • Use of steroid medications in the following manners: history of daily oral steroid dosing for >1 month during the past year, or burst or steroid course in the past 3 months, or >1 burst oral steroid course in the past year or use of oral or parenteral steroids for a non-asthma indication within the past 30 days
  • Asthma requiring >1 hospitalization in the past year for asthma or >1 ED visit in the past 6 months for asthma
  • Any previous intubation/mechanical ventilation due to allergies or asthma
  • Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulatory or biologic therapy in the past year
  • Use of beta-adrenergic blockers, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or calcium channel blockers in the past 30 days
  • Inability to discontinue antihistamines for skin testing and OFC
  • History of alcohol or drug abuse
  • History of cardiovascular disease, uncontrolled hypertension, arrhythmias, chronic lung disease, active eosinophilic gastrointestinal disease, or other medical conditions including immunologic disorders or HIV infection which, in the opinion of the investigator, make the subject unsuitable for treatment or at increased risk of anaphylaxis or poor outcome
  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: NCT01904604

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Maryland
The Johns Hopkins University
Baltimore, Maryland, United States
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States
United States, North Carolina
University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, United States
Sponsors and Collaborators
Consortium of Food Allergy Research
Investigators
Principal Investigator: Hugh Sampson, M.D. Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01904604     History of Changes
Other Study ID Numbers: DAIT CoFAR6, 5U19AI066738-07
Study First Received: July 15, 2013
Last Updated: August 25, 2014
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Peanut Allergy
Food Allergy
Viaskin peanut patch
Allergen Immunotherapy
Epicutaneous Immunotherapy
Whole peanut extract
Allergenic product
Immediate hypersensitivity

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

ClinicalTrials.gov processed this record on October 21, 2014