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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03476993
• Date of registration: 20/03/2018
• Prospective Registration: Yes
• Primary sponsor: Biocad
• Public title: Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary Cholangitis
• Scientific 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
• Date of first enrolment: April 27, 2018
• Target sample size: 9
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03476993
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Russian Federation

Contacts

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

Key inclusion & exclusion 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 ??? = 1:40 or PBC-specific AN? (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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Liver Cirrhosis, Biliary

Intervention(s)

Biological: BCD-085

Primary Outcome(s)

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]

Secondary ID(s)

BCD-085-6

Source(s) of Monetary Support

Please refer to primary and secondary sponsors