Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy
The purpose of this phase 1b study is to evaluate the safety and tolerability of repeated epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device) in peanut allergic subjects.
Biological: Whole peanut extract
Biological: Placebo formulation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Epicutaneous Immunotherapy (EPIT) for Peanut Allergy: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Safety Study in Adult and Pediatric Subjects|
- Safety evaluation [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
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.
- Systemic reactions evaluation and treatment; treatment adherence [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
- 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
|Study Start Date:||July 2010|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: DBV712 Viaskin
The experimental arm is composed of subjects treated with whole peanut extract on an epicutaneous delivery system (Viaskin patch)
Biological: Whole peanut extract
Four different doses of whole peanut extract expressed as micrograms (mcg) of peanut proteins (20, 100, 250, 500 mcg) and two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested for determination of the maximum tolerated dose during a 2-week treatment period.
Other Name: DBV712 Viaskin
Placebo Comparator: Placebo Viaskin
The placebo arm is composed of subjects treated with a placebo formulation on an epicutaneous delivery system (Viaskin patch)
Biological: Placebo formulation
Matching placebo at two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested in parallel to the peanut proteins doses for determination of the maximum tolerated dose during a 2-week treatment period.
Other Name: Placebo Viaskin
Peanut allergy is a common allergy in the United States, with a prevalence in the general population as high as 1%. So far, there is no approved treatment of peanut allergy. Peanut allergy management is based on strict peanut avoidance and injectable epinephrine after the allergic systemic reactions have started. Specific Immunotherapy methods currently available have shown some limitations in their use because of safety issues. Hence, there is an important unmet medical need for efficient and safe treatment of peanut allergy.
DBV Technologies has developed an epicutaneous delivery system, called Viaskin, a method based on delivering precise quantity of the allergen on the upper layers of the skin. Avoiding contact between the allergen and the bloodstream should confer to epicutaneous immunotherapy (EPIT) a higher level of safety as systemic reactions should be circumvented.
The aim of this phase 1b study is to evaluate the safety and tolerability of the epicutaneous immunotherapy method in subjects allergic to peanut. The trial will randomize 110 participants. Four doses of peanut proteins, 20 mcg, 100 mcg, 250 mcg and 500 mcg will be repeatedly delivered on the skin by dose escalation in consecutive cohorts of 5 subjects, starting with the lowest dose. In each cohort of 5, 4 subjects will receive peanut proteins and one will receive placebo in a blinded manner. For each dose, the peanut proteins will be applied on the skin either every day or every other day. The total duration of the treatment for each subject is 2 weeks. Firstly, adult subjects (18 to 50 years) with a history of non-severe anaphylaxis to peanut (Grade ≤3) will enroll and safety information be reviewed. If there are no major concerns, adolescent cohorts (12 to 17 years) with history of non-severe anaphylaxis to peanut will then enroll and safety again be reviewed. If there are no concerns, then child cohorts (6 to 11 years) with history of non-severe anaphylaxis to peanut will finally enroll.
Also, after the safety review of the treated adult non-severe cohorts is satisfactorily performed, adult subjects with a history of severe anaphylaxis to peanut (Grades 4 or 5) will enroll and dose escalation will undergo.
For the safety review, all the following parameters will be checked at each patient visit: physical examination, vital signs, skin examination, lab values, PEF values. FEV1, skin prick test to peanut and peanut-specific IgE values will also be determined at screening and end of treatment visits.
|United States, Arkansas|
|Arkansas Children's Hospital|
|Little Rock, Arkansas, United States, 72202|
|United States, Colorado|
|National Jewish Health|
|Denver, Colorado, United States, 80206|
|United States, New Jersey|
|Willingboro, New Jersey, United States, 08046|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Utah|
|Aspen Clinical Research|
|Orem, Utah, United States, 84058|