The trial aims to prove the non-inferiority of the investigational drug in two dosages as compared with the reference drug, as well as to assess its safety and tolerability. This study will be conducted in three arms in the form of a parallel group comparison. It is planned to randomize more than 650 male and female patients aged from 18 to 70 years old. The enrollment will take about 24 months with up to 100 investigational sites in Europe being involved.
In this project, OCT team is in charge of selection and monitoring of sites in Russia and Ukraine, corresponding interaction activities, drug import, export of biological samples, investigators meeting and regulatory support.