Overview

This trial is active, not recruiting.

Conditions peanut hypersensitivity, food hypersensitivity, hypersensitivity, hypersensitivity, immediate
Treatments high-dose dbv712 viaskin® patch, low-dose dbv712 viaskin® patch, placebo viaskin patch
Phase phase 2
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator Consortium of Food Allergy Research
Start date September 2013
End date August 2015
Trial size 75 participants
Trial identifier NCT01904604, 5U19AI066738-07, DAIT CoFAR6

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
high-dose dbv712 viaskin® patch
250 microgram (mcg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
(Experimental)
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.
low-dose dbv712 viaskin® patch
100 microgram (mcg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
(Placebo Comparator)
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.
placebo viaskin patch Placebo Patch
Placebo (e.g., no antigen) path in an epicutaneous application for 24 hours every 24 hours.

Primary Outcomes

Measure
Percent of subjects desensitized to peanut protein
time frame: after 52 weeks of therapy

Secondary Outcomes

Measure
Percent of subjects desensitized to peanut protein
time frame: after 30 months of therapy (week 130)
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)
Percent of desensitized subjects by dose level
time frame: after 52 weeks of therapy
Percent of desensitized subjects as measured by successful 5044 mg peanut protein OFC.
time frame: after 52 weeks of therapy
Number of all adverse events related to therapy
time frame: Baseline to 30 months of therapy (week 130)
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)
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)
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

Eligibility Criteria

Male or female participants from 4 years up to 25 years old.

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

Additional Information

Official title Epicutaneous Immunotherapy (EPIT) for Peanut Allergy: A Randomized, Double-Blind, Placebo-Controlled, Phase II Study in Children and Adults (DAIT COFAR6)
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID).