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

NCT03476993 | Terminated Phase 2

• 1 other identifier: BCD-085-6
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

primary biliary cholangitis; IL-17 monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with alkaline phosphatase (ALP) decrease > 40% from Baseline (day 1 week 0) or with normal ALP level (Barcelona criteria) after 24 weeks of treatment with BCD-085 in combination with UDCA.

  Biochemical response is defined as ALP decrease \> 40% from Baseline or normalisation of ALP level (Barcelona criteria).

  week 24

Study Arms (1)

BCD-085

EXPERIMENTAL

All patients will receive BCD-085 (subcutaneous injection) in combination with ursodeoxycholic acid (UDCA) in standard dose 13-15 mg/kg/day

Biological: BCD-085

Interventions

BCD-085 BIOLOGICAL

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.

BCD-085

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singed informed consent form (ICF)
• Men and women, age 18 - 80 years at the time of signing the ICF
• Established diagnosis of PBC with following criteria (according to EASL 2017 guidelines):
• documented ALP elevation
• documented АМА ≥ 1:40 or PBC-specific ANА (anti-sp100/anti-gp210).
• Suboptimal response to ursodeoxycholic acid (UDCA) taken in stable dose for at least 6 months before signing ICF with screening alkaline phosphatase (ALP) level \> 1.67 ULN (the upper limit of normal)
• Fertile patients and their partners agree to use barrier contraception throughout the study and 4 weeks after its completion.

You may not qualify if:

• History of gastrointestinal bleeding, hepatic encephalopathy or ascites requiring treatment with diuretics.
• MELD ≥ 15, history of liver transplantation, staying in the Liver Transplant Waiting List.
• Established diagnosis of hepatocellular carcinoma (HCC), hepatorenal syndrome.
• Direct bilirubin \> 1.0 mg/dL at screening.
• Documented diagnosis: nonalcoholic steatohepatitis, autoimmune hepatitis, primary sclerosing cholangitis, alcoholic liver disease, Gilbert's syndrome, Wilson disease, hemochromatosis, alfa-1-antitrypsin deficiency.
• HIV, hepatitis B, hepatitis C or syphilis.
• Use of colchicine, methotrexate, azathioprine or systemic corticosteroids within 3 months before signing the ICF.
• Previous use of monoclonal antibodies targeting IL17 or its receptor.
• Vaccination with live or attenuated vaccines within 8 weeks before signing the ICF.
• Any active systemic infection or recurrent infection at screening or 30 days before signing the ICF.
• Established diagnosis of chronic disease (e.g. sepsis, invasive mycosis, histoplasmosis etc.) that may increase the risk of infectious adverse events during the study.
• Severe infections (including those that required hospitalization or parenteral antibacterial/antimycotic/antiprotozoal treatment) within 6 months before signing the ICF
• Established diagnosis of herpes zoster infection (or history of herpes zoster infection).
• latent tuberculosis infection (positive results of the Diaskintest or QuantiFERON test, or T-spot).
• Concurrent diseases at screening that may increase the risk of adverse events during the study or affect the evaluation of PBC symptoms (mask, enhance or alter the symptoms of PBC, or cause clinical or laboratory signs/symptoms similar to those of PBC)

Sponsors & Collaborators

• Biocad: lead

Study Sites (3)

State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University

Moscow, Russia

Location

North-Western State Medical University named after I.I. Mechnikov

Saint Petersburg, Russia

Location

Smolensk state medical university

Smolensk, Russia

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marina Maevskaya

  State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 26, 2018
• Study Start: April 27, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)