Peanut Epicutaneous Phase II Immunotherapy Clinical Trial

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2018-08-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peanut Hypersensitivity Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type PLACEBO_COMPARATOR

Placebo Viaskin® Patch

Intervention Type BIOLOGICAL

Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.

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).

Group Type EXPERIMENTAL

Low-dose DBV712 Viaskin® Patch

Intervention Type BIOLOGICAL

100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

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).

Group Type EXPERIMENTAL

High-dose DBV712 Viaskin® Patch

Intervention Type BIOLOGICAL

250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

Interventions

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Placebo Viaskin® Patch

Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.

Intervention Type BIOLOGICAL

Low-dose DBV712 Viaskin® Patch

100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

Intervention Type BIOLOGICAL

High-dose DBV712 Viaskin® Patch

250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No