OCT Has Obtained Regulatory Approval For the Phase III Study in Ulcerative Colitis in Russia
OCT has obtained approval to conduct a study of the drug for the treatment of patients with ulcerative colitis.
This is a multicenter, double-blind, randomized, placebo-controlled phase III study. The treatment period is 8 weeks. The planned recruitment target is 180 female and male patients aged from 18 to 65.
The study is aimed at measuring the efficacy of the study drug vs. active comparator.
Within this project, OCT is responsible for a scope of services including regulatory support, logistics, patient enrollment, project management, clinical and medical monitoring.Back to the list