NCT03476993

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Biocad · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Liver Cirrhosis, Biliary

Interventions

Type	Name	Description
BIOLOGICAL	BCD-085	All patients will receive BCD-085 (subcutaneous injections) once a week during the period of induction of remission, then once every 2 weeks during the period of remission maintenance and then once every 4 weeks during the period of accumulation of treatment effect. All patients will receive ursodeoxycholic acid (UDCA) in standard dose 13-15 mg/kg/day.

Timeline

• Start date: 2018-04-27
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2018-03-26
• Last updated: 2019-10-11

Locations

3 sites across 1 country: Russia