Liver Cirrhosis, BiliaryPhase 2NCT03476993
Non-comparative Study of BCD-085 in Combination With UDCA in Patients With Primary Biliary Cholangitis
A Phase 2 study testing BCD-085 in people with Liver Cirrhosis, Biliary, run by Biocad at 3 sites in Russia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Cirrhosis, Biliary
- What is being tested?
- BCD-085
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesRussia
- Study dates
- 27 Apr 2018to 1 Jul 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)
- Known allergy or intolerance to monoclonal antibody drugs (murine, chimeric, humanized, or human) or any other components of BCD-085.
- Pregnancy, breastfeeding or planning of pregnancy during the study.
- 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.
- Alcohol or substance abuse.
- Participation in other clinical trials within less than 90 days before signing the ICF.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
Moscow
North-Western State Medical University named after I.I. Mechnikov
Saint Petersburg
Smolensk state medical university
Smolensk
About this study
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
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).
Read the 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
- Being tested
- BCD-085
- Keywords
- primary biliary cholangitis, IL-17 monoclonal antibody
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-085Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: BCD-085 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start27 Apr 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Why it stopped: Sponosor's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cirrhosis, BiliaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marina Maevskaya, Principal investigator, State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476993
- Sponsor's protocol ID
- BCD-085-6
- Status last verified
- Oct 2019
- First submitted
- 20 Mar 2018
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03476993
- Acronym / sponsor ID
- BCD-085-6
- Conditions
- Liver Cirrhosis, Biliary
- Keywords
- primary biliary cholangitis, IL-17 monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponosor's decision
- Enrolment
- 9 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCD-085 | Experimental | Biological: BCD-085All patients will receive BCD-085 (subcutaneous injection) in combination with ursodeoxycholic acid (UDCA) in standard dose 13-15 mg/kg/day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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):
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCD-085All 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. | Biological | BCD-085 |
Primary outcome
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).
Results and safety
The study was stopped early (reason given: Sponosor's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Maevskaya principal investigator
State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BCD-085 in people with Liver Cirrhosis, Biliary, run by Biocad at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponosor's decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.