Peanut Epicutaneous Phase II Immunotherapy Clinical Trial
Epicutaneous Immunotherapy (EPIT) for Peanut Allergy: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study in Children and Adults (DAIT COFAR6)
2 other identifiers
interventional
75
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2013
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2013
CompletedFirst Posted
Study publicly available on registry
July 22, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedResults Posted
Study results publicly available
August 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2018
CompletedJuly 1, 2019
June 1, 2019
1.9 years
July 15, 2013
July 15, 2016
June 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects With a Successful Treatment Response
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.
Week 52
Secondary Outcomes (7)
Percentage of Subjects Desensitized to Peanut Protein
Week 130 (Month 30)
Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein
Week 130 (Month 30)
Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)
Week 52
Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)
Week 52
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)
8 and 20 weeks after the Week 130 (Month 30) OFC
- +2 more secondary outcomes
Study Arms (3)
Placebo Patch
PLACEBO COMPARATORSubjects 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).
100 µg Peanut Patch
EXPERIMENTALSubjects 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).
250 µg Peanut Patch
EXPERIMENTALSubjects 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).
Interventions
Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.
100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
National Jewish Health
Denver, Colorado, 80206, United States
The Johns Hopkins University
Baltimore, Maryland, 21287, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27599, United States
Related Publications (4)
Keet CA, Wood RA. Emerging therapies for food allergy. J Clin Invest. 2014 May;124(5):1880-6. doi: 10.1172/JCI72061. Epub 2014 May 1.
PMID: 24789880BACKGROUNDJones SM, Sicherer SH, Burks AW, Leung DY, Lindblad RW, Dawson P, Henning AK, Berin MC, Chiang D, Vickery BP, Pesek RD, Cho CB, Davidson WF, Plaut M, Sampson HA, Wood RA; Consortium of Food Allergy Research. Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults. J Allergy Clin Immunol. 2017 Apr;139(4):1242-1252.e9. doi: 10.1016/j.jaci.2016.08.017. Epub 2016 Oct 26.
PMID: 28091362RESULTScurlock AM, Burks AW, Sicherer SH, Leung DYM, Kim EH, Henning AK, Dawson P, Lindblad RW, Berin MC, Cho CB, Davidson WF, Plaut M, Sampson HA, Wood RA, Jones SM; Consortium for Food Allergy Research (CoFAR). Epicutaneous immunotherapy for treatment of peanut allergy: Follow-up from the Consortium for Food Allergy Research. J Allergy Clin Immunol. 2021 Mar;147(3):992-1003.e5. doi: 10.1016/j.jaci.2020.11.027. Epub 2020 Dec 5.
PMID: 33290772DERIVEDChiang D, Chen X, Jones SM, Wood RA, Sicherer SH, Burks AW, Leung DYM, Agashe C, Grishin A, Dawson P, Davidson WF, Newman L, Sebra R, Merad M, Sampson HA, Losic B, Berin MC. Single-cell profiling of peanut-responsive T cells in patients with peanut allergy reveals heterogeneous effector TH2 subsets. J Allergy Clin Immunol. 2018 Jun;141(6):2107-2120. doi: 10.1016/j.jaci.2017.11.060. Epub 2018 Jan 31.
PMID: 29408715DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research Program
- Organization
- DAIT/NIAID
Study Officials
- STUDY CHAIR
Stacie M. Jones, MD
University of Arkansas
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2013
First Posted
July 22, 2013
Study Start
September 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 21, 2018
Last Updated
July 1, 2019
Results First Posted
August 26, 2016
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After completion of the trial.
- Access Criteria
- After completion of the trial.
The plan is to share data in ImmPort \[https://immport.niaid.nih.gov/ \], a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.