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Peanut Epicutaneous Phase II Immunotherapy Clinical Trial

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: July 15, 2016
Last verified: July 2016
  Purpose
Food allergy occurs 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.

Condition Intervention Phase
Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity
Hypersensitivity, Immediate
Biological: Placebo Viaskin® Patch
Biological: Low-dose DBV712 Viaskin® Patch
Biological: High-dose DBV712 Viaskin® Patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover 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:
  • Percentage of Subjects With a Successful Treatment Response [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    Treatment response is defined as a subject who can either (a) successfully consume a cumulative dose of peanut protein equal to or greater than 5044 mg or (b) successfully consume at least a 10-fold increase in peanut protein at the Week 52 oral food challenge (OFC), when compared to the cumulative successfully consumed dose at the baseline OFC.


Secondary Outcome Measures:
  • Percentage of Subjects Desensitized to Peanut Protein [ Time Frame: Week 130 (Month 30) ] [ Designated as safety issue: No ]

    Desensitization is defined based on successfully consumed dose in mg protein at the Week 130 oral food challenge (OFC) as follows:

    1) 0-44 mg at BL, >=444 mg at Wk 130 2) >44-<444 mg at BL, 10-fold increase at Wk 130 3) >=444 mg at BL, >=5,044 mg at Wk 130.

    BL=Baseline, Wk 130=Week 130 (Month 30)


  • Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein [ Time Frame: Week 130 (Month 30) ] [ Designated as safety issue: No ]
    Subjects who successfully consumed without dose-limiting symptoms 1044 mg or 5044 mg peanut protein during the Week 130 oral food challenge (OFC).

  • Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

    Desensitization is defined based on successfully consumed dose in mg protein at the Week 52 oral food challenge (OFC) as follows:

    0-44 mg at BL, >=444 mg at Wk52 2) >44-<444 mg at BL, 10-fold increase at Wk 52 3) >=444 mg at BL, >=5,044 mg at Wk 52.

    BL=Baseline, Wk 52=Week 52


  • Average Successfully Consumed Dose in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
    The successfully consumed dose (SCD) is the cumulative dose consumed during an oral food challenge without dose-limiting symptoms that led to the termination of the challenge.

  • Percentage of Subjects Who Pass an OFC to 5044 mg of Peanut Protein Followed by an Open Feeding of Peanut Butter After 8 Weeks or 20 Weeks of Discontinuation of Dosing Subsequent to Passing the Week 130 Oral Food Challenge (OFC) [ Time Frame: 8 and 20 weeks after the Week 130 (Month 30) OFC ] [ Designated as safety issue: No ]
    Subjects who after passing the Week 130 (Month 30) discontinue dosing for 8 weeks and later 20 weeks successfully consumed 5044 mg peanut protein during an OFC followed by an open feeding of peanut butter.

  • Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months [ Time Frame: Week 52 and Month 30 (Week 130) ] [ Designated as safety issue: Yes ]
    Adverse events (AEs) related to study therapy includes both unsolicited AEs where there was a reasonable possibility that the study product caused the event as well as solicited AEs related to dosing.

  • Percentage of Subjects Who Successfully Complete the Dosing Regimen With no More Than Mild Symptoms Related to Peanut Patch Dosing After 30 Months of Therapy [ Time Frame: Month 30 (Week 130) ] [ Designated as safety issue: Yes ]
    Mild symptoms related to peanut patch dosing are defined as patch site reactions up to Grade 2 in severity or mild systemic dosing symptoms.


Enrollment: 75
Study Start Date: September 2013
Estimated Study Completion Date: December 2018
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Patch
Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Biological: Placebo Viaskin® Patch
Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.
Experimental: 100 µg Peanut Patch
Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).
Biological: Low-dose DBV712 Viaskin® Patch
100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
Experimental: 250 µg Peanut Patch
Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).
Biological: High-dose DBV712 Viaskin® Patch
250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

Detailed Description:
This study will evaluate whether peanut epicutaneous immunotherapy can protect individuals 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.
  Eligibility

Ages Eligible for Study:   4 Years to 25 Years   (Child, Adult)
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) in oral food challenge (OFC)
  • 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 Emergency Department (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, 21287
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Consortium of Food Allergy Research
Investigators
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: NCT01904604     History of Changes
Other Study ID Numbers: DAIT CoFAR6  5U19AI066738-07 
Study First Received: July 15, 2013
Results First Received: July 15, 2016
Last Updated: July 15, 2016
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration
United States: Data and Safety Monitoring 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:
Hypersensitivity
Food Hypersensitivity
Peanut Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2016