MedTrace Logo

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

NCT03476993 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-10-11

No results posted yet for this study

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).

Conditions

  • Liver Cirrhosis, Biliary

Interventions

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.

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Principal Investigators

  • Marina Maevskaya · State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-27
Primary Completion
2019-07-01
Completion
2019-07-01

Countries

  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03476993 on ClinicalTrials.gov