French biopharmaceutical company DBV Technologies (DBV) has started the Phase III REAL LIfe Use and Safety of EPIT (REALISE) study of Viaskin Peanut 250 μg to treat children allergic to peanuts.
Viaskin Peanut is based on DBV’s patented technology platform, epicutaneous immunotherapy (EPIT), which issues biologically active compounds to the immune system through the skin.
The multicentre, randomised, double-blind, placebo-controlled Phase III REALISE trial has been designed to evaluate the comparable safety of Viaskin Peanut 250 μg administered to children aged four to 11 years against placebo.
The trial is expected to enrol about 335 patients.
During the first six months of the trial, the patients will be randomised on a 3:1 ratio to be treated with Viaskin Peanut and placebo.
The trial will mainly examine the treatment-emergent adverse events after the first six months and the patients will be continued to be monitored during the open-label portion of the study.
DBV Technologies chief medical officer Dr Lucia Septien said: “With REALISE, we want to capture that enthusiasm, and increase the number of patients and centres that are currently participating in one of our four clinical trials with a Viaskin product candidate.
“This trial also gives our investigators the opportunity to study patients with severe anaphylaxis, who have been excluded from pharmaceutical development to date, but are in serious need of treatment.”
The trial will be conducted in conjunction with the Peanut EPIT Efficacy and Safety Study (PEPITES) study and is seen as the company’s attempt to expand its global clinical development programme for children allergic to peanuts.