Clinical Trial: Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Epicutaneous Immunotherapy (EPIT) for Peanut Allergy: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Safety Study in Adult and Pediatric Subjects

Brief Summary: 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.

Detailed Summary:

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 a
Sponsor: DBV Technologies

Current Primary Outcome: 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. ]

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.



Original Primary Outcome: 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. ]

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 analyis, 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.



Current Secondary Outcome: 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. ]

Secondary outcomes:

  1. 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.
  2. The proportion of subjects requiring treatment for systemic reactions related to experimental treatment or placebo.
  3. Overall adherence to the study treatment


Original Secondary Outcome: Same as current

Information By: DBV Technologies

Dates:
Date Received: July 24, 2010
Date Started: July 2010
Date Completion:
Last Updated: March 22, 2012
Last Verified: March 2012