Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 24 of 34 for:    Biliary Cirrhosis, Primary, 4

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03476993
Recruitment Status : Terminated (Sponosor's decision)
First Posted : March 26, 2018
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Biocad

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).

Condition or disease Intervention/treatment Phase
Liver Cirrhosis, Biliary Biological: BCD-085 Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 27, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019


Arm Intervention/treatment
Experimental: BCD-085
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
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.




Primary Outcome Measures :
  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. [ Time Frame: week 24 ]
    Biochemical response is defined as ALP decrease > 40% from Baseline or normalisation of ALP level (Barcelona criteria).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Singed informed consent form (ICF)
  2. Men and women, age 18 - 80 years at the time of signing the ICF
  3. 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).
  4. 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)
  5. Fertile patients and their partners agree to use barrier contraception throughout the study and 4 weeks after its completion.

Exclusion Criteria:

  1. History of gastrointestinal bleeding, hepatic encephalopathy or ascites requiring treatment with diuretics.
  2. MELD ≥ 15, history of liver transplantation, staying in the Liver Transplant Waiting List.
  3. Established diagnosis of hepatocellular carcinoma (HCC), hepatorenal syndrome.
  4. Direct bilirubin > 1.0 mg/dL at screening.
  5. Documented diagnosis: nonalcoholic steatohepatitis, autoimmune hepatitis, primary sclerosing cholangitis, alcoholic liver disease, Gilbert's syndrome, Wilson disease, hemochromatosis, alfa-1-antitrypsin deficiency.
  6. HIV, hepatitis B, hepatitis C or syphilis.
  7. Use of colchicine, methotrexate, azathioprine or systemic corticosteroids within 3 months before signing the ICF.
  8. Previous use of monoclonal antibodies targeting IL17 or its receptor.
  9. Vaccination with live or attenuated vaccines within 8 weeks before signing the ICF.
  10. Any active systemic infection or recurrent infection at screening or 30 days before signing the ICF.
  11. Established diagnosis of chronic disease (e.g. sepsis, invasive mycosis, histoplasmosis etc.) that may increase the risk of infectious adverse events during the study.
  12. Severe infections (including those that required hospitalization or parenteral antibacterial/antimycotic/antiprotozoal treatment) within 6 months before signing the ICF
  13. Established diagnosis of herpes zoster infection (or history of herpes zoster infection).
  14. latent tuberculosis infection (positive results of the Diaskintest or QuantiFERON test, or T-spot).
  15. 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)
  16. Known allergy or intolerance to monoclonal antibody drugs (murine, chimeric, humanized, or human) or any other components of BCD-085.
  17. Pregnancy, breastfeeding or planning of pregnancy during the study.
  18. Any psychiatric conditions including severe depressive disorders and/or any history of suicidal thoughts or suicidal attempts that may constitute the excessive risk for the patient or that may affect the patient's ability to follow the protocol.
  19. Alcohol or substance abuse.
  20. Participation in other clinical trials within less than 90 days before signing the ICF.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476993


Locations
Layout table for location information
Russian Federation
State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
Moscow, Russian Federation
North-Western State Medical University named after I.I. Mechnikov
Saint Petersburg, Russian Federation
Smolensk state medical university
Smolensk, Russian Federation
Sponsors and Collaborators
Biocad
Investigators
Layout table for investigator information
Principal Investigator: Marina Maevskaya State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University

Layout table for additonal information
Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT03476993     History of Changes
Other Study ID Numbers: BCD-085-6
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biocad:
primary biliary cholangitis
IL-17 monoclonal antibody
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Cirrhosis
Liver Cirrhosis, Biliary
Biliary Tract Diseases
Cholangitis
Liver Diseases
Digestive System Diseases
Bile Duct Diseases
Cholestasis, Intrahepatic
Cholestasis
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents