Treatment of peanut allergy in adults and children age 7 years and older with documented hypersensitivity to peanut. The induction of clinical desensitization to peanut in patients allergic to peanut should reduce the risk of anaphylaxis in case of accidental exposure to small amounts of peanut proteins. MedDRA version: 16.1 Level: LLT Classification code 10034202 Term: Peanut allergy System Organ Class: 100000004870
Conditions
Interventions
Product Name: Viaskin Peanut
Product Code: DBV712
Pharmaceutical Form: Cutaneous patch
INN or Proposed INN: peanut allergen extract
Other descriptive name: peanut allergen extract
Concentration unit:
Sponsors
DBV Technologies S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult and pediatric subjects (=7 years) who completed the VIPES study, with a mandatory and documented Double-Blind Placebo-Controlled Food Challenge (DBPCFC) at Month 12 in the VIPES study. Are the trial subjects under 18? yes Number of subjects for this age range: 180 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Severe reaction during the DBPCFC at Month 12 in the VIPES study, defined as need for intubation, hypotension persisting after epinephrine administration, and/or the need for more than two doses of epinephrine. 2. Pregnancy or lactation. 3. Females of childbearing potential planning a pregnancy in the coming 2 to 3 years. 4. Subjects who became allergic to chocolate or who do not want to consume the chocolate study challenge vehicle anymore. 5. Subjects who developed hypersensitivity to excipients of the Viaskin patches or of the food challenge formula used during the VIPES study. 6. Inability to discontinue short-acting antihistamines for three days or long-acting antihistamines for five to seven days (depending on half-life) prior to skin prick testing or food challenges. 7. Subjects with asthma that has evolved and now fulfills any of the criteria defined as follows: a. uncontrolled persistent asthma by National Asthma Education and Prevention Program Asthma guidelines (2007) or by Global Initiative for Asthma (2011) or being treated with combination therapy of medium dose inhaled corticosteroid with a long acting inhaled ß2-agonists. b. at least two systemic corticosteroid courses for asthma in the past year or one oral corticosteroid course for asthma in the past three months. c. prior intubation for asthma in the past year. 8. Subjects receiving ß-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy. 9. Subjects receiving or planning to receive anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy. 10. Subjects receiving or planning to receive any type of immunotherapy to any food (e.g. oral immunotherapy, sublingual immunotherapy, specific oral tolerance induction) during their participation in the study. 11. Subjects receiving or planning to receive any aeroallergen immunotherapy during their participation in the study. 12. Allergy or know history of reaction to Tegaderm® with no possibilities to use an alternative dressing approved by the sponsor. 13. Subjects suffering from generalized dermatologic disease (e.g. severe atopic dermatitis, uncontrolled generalized eczema, ichthyosis vulgaris) with no intact zones to apply the Viaskin® patches. 14. Subjects or parent(s)/guardian(s) of subjects with obvious excessive anxiety and unlikely to cope with the conditions of a food challenge. 15. Past or current disease(s) which, in the opinion of the Investigator or the Sponsor, may affect the subject’s participation in this study, including but not limited to active eosinophilic gastrointestinal disorders, autoimmune disorders, immunodeficiency, malignancy, uncontrolled diseases (e.g. hypertension, psychiatric, cardiac), or other disorders (e.g. liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders). 16. Any new disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias. 17. A history of drug or alcohol abuse while in the VIPES study. 18. A history of non compliance in the VIPES study. Non compliance is defined as subjects not applying the patch at all for 60 days or more (this can be either consecutive or intermittent non application of the patches) during the whole VIPES study duration. 19. Subjects unable to follow the protocol requirem
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of Viaskin Peanut after up to 36 months of Epicutaneous Immunotherapy (EPIT) in peanut-allergic subjects.;Secondary Objective: To evaluate the safety of long-term treatments with Viaskin Peanut. To evaluate the sustained unresponsiveness to peanut after a period of 2 months without treatment in subjects showing desensitization to peanut after EPIT with Viaskin Peanut. ;Primary end point(s): Efficacy endpoints: 1/ Proportion of subjects with a peanut protein eliciting dose equal to or greater than 1000 mg peanut or with a =10-fold increase of the eliciting dose compared to their baseline eliciting dose observed in the VIPES study. 2/ The proportion of subjects unresponsive (i.e. showing no objective symptoms during DBPCFC) to a cumulative dose of 1440 mg peanut protein or above. 3/ The proportion of subjects with a sustained unresponsiveness (i.e. showing no objective symptoms during DBPCFC after a period of 2 months without treatment) to a cumulative dose of 1440 mg peanut protein or above at Month 26.;Timepoint(s) of evaluation of this end point: 1/ Month 12 and month 24 2/ Month 12 and month 24 3/ Month 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Initial visit and 6, 12, 18, 24, 26 months;Secondary end point(s): Safety endpoints: Adverse events (AEs) by system organ class, severity and relatedness to Viaskin® Peanut (all subjects and by age strata). Serious AEs (SAEs) by system organ class, severity and relatedness to Viaskin® Peanut (all subjects and by age strata). Systemic allergic symptoms and relatedness to Viaskin® Peanut (all subjects and by age strata). Severity of AEs or SAEs elicited during the study and the DBPCFCs (all subjects). Laboratory data, physical examinations and vital signs (all subjects). Spirometry results (all subjects). | — |
Countries
Canada, France, Netherlands, United States
Contacts
Public ContactClinical trials officer
DBV Technologies S.A
Outcome results
None listed