This is an open-label proof-of-concept phase 2A study. The aim of the study is to evaluate the efficacy and safety of BCD-085 in combination with ursodeoxycholic acid in patients with primary biliary cholangitis (PBC) with compensated liver function with an inadequate (suboptimal) response to ursodeoxycholic acid.~In this study the inadequate (suboptimal) response to ursodeoxycholic acid (UDCA) is defined as screening alkaline phosphatase (ALP) level > 1.67 ULN (the upper limit of normal) despite treatment with UDCA in stable dose for at least 6 months before signing the ICF.
BCD-085 is an innovative drug, anti-interleukin-17 monoclonal antibody. The aim of the study is to evaluate the efficacy and safety of BCD-085 in patients with primary biliary cholangitis (PBC).