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Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary Cholangitis

Liver Cirrhosis, Biliary Clinical Trial

Official title:
Open-label Non-comparative Study to Evaluate the Efficacy and Safety of BCD-085 (JSC BIOCAD, Russia) in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cholangitis

Clinical Trial Summary

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).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03476993
Study type Interventional
Source Biocad
Contact
Status Terminated
Phase Phase 2
Start date April 27, 2018
Completion date July 1, 2019
View Details
See also
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