Phase 2 N=75 Randomized Quadruple-blind Treatment

Peanut Epicutaneous Phase II Immunotherapy Clinical Trial

Peanut Hypersensitivity · Food Hypersensitivity · Hypersensitivity · Hypersensitivity, Immediate

Bottom Line

View on ClinicalTrials.gov: NCT01904604 ↗

Enrolled (actual)

Serious AEs

3.2%

Results posted

Aug 2016

Primary outcome: Primary: Percentage of Subjects With a Successful Treatment Response — 12.0; 45.8; 48.0 percentage of participants — p=0.005

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo Viaskin® Patch (Biological); Low-dose DBV712 Viaskin® Patch (Biological); High-dose DBV712 Viaskin® Patch (Biological)
Age: Pediatric, Adult · 4+ yrs
Sex: All
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With a Successful Treatment Response	12.0; 45.8; 48.0	0.005 sig
SECONDARY Percentage of Subjects Desensitized to Peanut Protein	5.0; 20.8; 36.0	—
SECONDARY Percentage of Subjects Who Can Successfully Consume 1044 mg or 5044 mg Peanut Protein	10.0; 16.7; 32.0; 0.0; 0.0; 0.0	—
SECONDARY Percentage of Desensitized Subjects in the Active Treatment Arms as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)	12.5; 20.0	—
SECONDARY Average Successfully Consumed Dose as Measured by 5044 mg Peanut Protein Oral Food Challenge (OFC)	14; 144; 144	0.80
SECONDARY 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)	—	—
SECONDARY Percentage of Subjects With Adverse Events Related to Therapy Through Week 52 and Through 30 Months	88.0; 100.0; 100.0; 100.0; 100.0; 100.0	—
SECONDARY 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	65.0; 62.5; 64.0	—

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.

Eligibility 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01904604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.