And remember, we also have our expanded access program for subjects that have completed in treatment in a DBV clinical trial. And once you continue to receive Viaskin Peanut. So that test is set up to provide another large robust dataset unmatched by any other peanut allergy study in this age group. Recall that the population in the test is considered to be more sensitive than subjects in our previous studies with the inclusion eliciting dose set at 100 milligrams. This is aligned with a younger four to seven year old age group, where we believe Viaskin Peanut can provide great clinical benefit. In the test we have 86 clinical centers spread across the US, Canada, Australia and Europe, sites in every country are open and actively recruiting subjects like other sponsors we were set back by the new European clinical trials directive, which significantly delayed our opening of our European sites.
However, that’s behind us now and we expect to build momentum and complete screening by Q3 this year. That brings me to the COMFORT Children supplemental safety study in four to seven year olds. This will have a six month core period followed by an open-label extension that will provide an additional six months of treatment for subjects randomized to active product and 12 months of treatment for subjects randomized to placebo. Every subjects will have the opportunity to receive Viaskin Peanut for a full year. This will be a 270 subjects study randomized three to one active to placebo. The main inclusion criteria will be based on skin prick test and peanut-specific IgE levels. These criteria are sufficient to ensure a similar patient population relative to the tests.
Thus, there is no need for a food challenge, as part of the inclusion criteria. One of the differences in COMFORT Children relative to the tests, is the use of a simplified instructions for use. The safety study IFU states each DBV’s 712 -microgram epi-cutaneous system is intended to be worn for a full day 24 hours. This is a shift away from the 24 plus minus four hours per day and the minimum wear time used in previous studies. This new IFU, more accurately reflects allergen immunotherapy and how we expect our product to be enabled, if approved. Based on a past similar safety study, we conducted in four to 11 year olds, we believe COMFORT Children would be on attractive study, with potential subjects and at research centers. Be assured that study start-up activities with our CRO have already begun so that we will be in a good position, to initiate the study at an optimal time.
Okay. Let’s move to the top of the program. The results from the first 12 months of the EPITOPE study were published last year in the New England Journal of Medicine. The Open-Label Extension to EPITOPE is ongoing. Recall that all subjects have the option to receive Viaskin Peanut for up to three years. For subjects or originally randomized to active treatment, we have data for two years on treatment and for those randomized to placebo, we have the one-year crossover data from placebo to active. These data were presented as the very first ever, late-breaker at the American College of Allergy, Asthma and Immunology annual meeting last November. In the interim data, from the Open-Label Extension to EPITOPE, we observed continued improvement and treatment response following the 2nd year of treatments, which is consistent with our previous Open-Label Extension data in four to 11 years olds.
Using the Responder criteria and EPITOPE, the response rate increased from 67% to almost 84% and four out of five subjects, 81% consumed an eliciting dose of greater than or equal to 1000 milligrams. To put this into perspective, the median eliciting dose at baseline was 100 milligrams. That’s a tenfold increase. Finally, participants consumed sorry 56% of participants consumed the entire food challenge of nearly 3.5 grams or about 14 peanut kernels without meeting the food challenge stopping criteria. We believe these are really impressive results that continue to build upon our extensive and robust Viaskin Peanut clinical dataset. During the 2nd year of treatment, the safety results in toddlers were entirely consistent with trials in older children, which demonstrated a well-tolerated, predictable safety profile.
Local application site reactions were the most commonly reported adverse events, though notably the frequency of such reactions decreased in the 2nd year of treatment with Viaskin Peanut. No subjects had treatment-related serious, treatment-emergent adverse events during the 2nd year of treatment, with Viaskin Peanut and no treatment related permanent study discontinuations occurred. Furthermore, there were no treatment related anaphylactic events, during the 2nd year of treatment with Viaskin Peanut. Remember, our studies used a very broad definition of anaphylaxis, principally designed to set a very low bar in reporting anaphylactic events. Overall, we were extremely pleased, with the results of the 2nd year of treatment from an efficacy point as well as from a safety point.
We didn’t present the placebo crossover data in the slides today, but it was discussed at the college meeting in November, and the placebo crossover efficacy and safety appeared to be virtually identical to the first 12 month data set in EPITOPE that was published in the New England Journal. This confirms, what was observed previously, and also provides reassurance that slightly older subjects of three year olds and EPITOPE that crossed over as four year olds in the Open-Label extension some had a robust treatment effect. This bodes well for the VITESSE study. Let me wrap-up with the toddler, COMFORT Toddler study. This is a six month study that will include 400 subjects randomized three to one active to placebo. Like the COMFORT Children study, subjects will have the opportunity to receive active treatment for up to one year.
COMFORT Toddlers will use the same IFU as COMFORT Children. So, there will be consistency between the two studies. This study will use the same square patch as the EPITOPE study. One of the differences between COMFORT Toddlers and COMFORT Children other than the obvious difference in age range and patch is that the toddler study will use a double-blind placebo-controlled food challenge as part of the inclusion criteria. We chose to include a food challenge to ensure that the study population in the safety study would be as closely matched to that as EPITOPE as possible. We believe the food challenge was the best way to ensure that outcome, unit-specific IgE is more reliable as a biomarker of peanut allergy in older children, but is less reliable in toddlers.
