Peanut allergy MedDRA version: 20.1 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
Current Sponsor code: DBV712
Concentration unit: % percent
Concentr
Sponsors
DBV Technologies S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or Female age 6 to 50 years at enrollment Physician-diagnosed peanut allergy or convincing history of peanut allergy regardless of the degree of the reaction A positive skin prick test to peanut allergen with a wheal diameter >8 mm AND peanut-specific IgE measured by ImmunoCAP >5kU/L. Use of an effective method of contraception by females of childbearing potential and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study. Women who have had a hysterectomy or tubal ligation at least 6 months prior to the screening visit or who have been post-menopausal for at least 1 year prior to the screening visit are not considered to be of childbearing potential. Ability to perform spirometry maneuvers in accordance with the American Thoracic Society guidelines (1994). Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participation in a study using an investigational new drug in the last 30 days prior to the screening visit. Participation in any interventional study for the treatment of food allergy in the past 6 months prior to the screening visit. Pregnancy or lactation. Allergy or known hypersensitivity to the Viaskin patch or adhesives. Severe or poorly controlled atopic dermatitis or generalized eczema. FEV1 value 1 month during the past year, or burst oral steroid course in the past 6 months, or >1 burst oral steroid course in the past year, prior to the screening visit. Use of oral steroids as described above after the screening visit and before randomization will render the subject non eligible for randomization. Asthma requiring 1 or more hospitalization(s) in the past year or >1 emergency department visit in the past 6 months, prior to the screening visit. Occurrence of asthma in these conditions after the screening visit and before randomization will render the subject non eligible for randomization. Use of omalizumab or immunomodulatory or biologic therapy in the past year prior to the screening visit. Use of nontraditional forms of allergen immunotherapy (such as oral immunotherapy or sublingual immunotherapy) in the past year prior to the screening visit. Use of subcutaneous immunotherapy other than a stable maintenance dose for less than a year prior to the screening visit. Use of beta-blockers, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers. Inability to discontinue antihistamines for at least 1 week to allow skin testing at the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of repeated application of “DBV712 Peanut allergy vaccine“ or “DBV712“ in adult, adolescent, and child subjects with a known allergy to peanut.;Secondary Objective: To evaluate the safety of DBV712 versus placebo by measuring the proportion of subjects who experienced and required a treatment for systemic reactions related to DBV712 or placebo and to evaluate the overall adherence to the study treatment.;Primary end point(s): The primary outcome measure is safety and the subjects will undergo the following procedures: physical examination including patch application site examination for evaluation of any skin reaction, vital signs, blood and urine collection for blood and urine analysis, ECG, Peak Expiratory Flow and spirometry (FEV1). Adverse events, treatment-emergent adverse events, and serious adverse events will be classified according to severity, treatment relatedness, the system/organ class affected, and the countermeasures taken. ;Timepoint(s) of evaluation of this end point: Safety evaluation to be performed at each visit during the 2-week treatment and at the follow-up visit one week after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Safety evaluation to be performed at each visit during the 2-week treatment and at the follow-up visit one week after the end of treatment. ;Secondary end point(s): The proportion of subjects that experience systemic reactions such as urticaria, asthma and acute dyspnea, change in blood pressure, and digestive symptoms (vomiting, diarrhea) associated with experimental treatment versus placebo. The proportion of subjects requiring treatment for systemic reactions related to experimental treatment or placebo. Overall adherence to the study treatment | — |
Countries
United States
Contacts
Public ContactClinical Trial
DBV Technologies
Outcome results
None listed