Peanut Epicutaneous Phase II Immunotherapy Clinical Trial

Phase 2

Completed

Conditions: Hypersensitivity
Peanut Hypersensitivity
Hypersensitivity, Immediate
Food Hypersensitivity

Interventions: Biological: Placebo Viaskin® Patch
Biological: High-dose DBV712 Viaskin® Patch
Biological: Low-dose DBV712 Viaskin® Patch

Registration Number: NCT01904604

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 75

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Patch	Placebo Viaskin® 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).
250 µg Peanut Patch	High-dose DBV712 Viaskin® 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).
100 µg Peanut Patch	Low-dose DBV712 Viaskin® 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).

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With a Successful Treatment Response	Week 52	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

Name	Time	Method
Percentage of Subjects Desensitized to Peanut Protein	Week 130 (Month 30)	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	Week 130 (Month 30)	Subjects who successfully consumed without dose-limiting symptoms 1044 mg or 5044 mg peanut protein during the Week 130 oral food challenge (OFC). This is referred to as the successfully consumed dose (SCD). The maximum SCD for this OFC was 5044 mg peanut protein.
Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)	Week 52	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 as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)	Week 52	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 Successfully Complete the Dosing Regimen With no More Than Mild Symptoms Related to Peanut Patch Dosing After 30 Months of Therapy	Month 30 (Week 130)	Mild symptoms related to peanut patch dosing are defined as patch site reactions up to Grade 2 in severity or mild systemic dosing symptoms.
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	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	Week 52 and Month 30 (Week 130)	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.

Trial Locations

Locations (5): Arkansas Children's Hospital
🇺🇸
Little Rock, Arkansas, United States
National Jewish Health
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Denver, Colorado, United States
The Johns Hopkins University
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Baltimore, Maryland, United States
University of North Carolina at Chapel Hill School of Medicine
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Chapel Hill, North Carolina, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States