Effectiveness of setanaxib in primary biliary cholangitis

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    What is this study about?

    This clinical trial aims to study the effectiveness of a new medication called setanaxib on patients suffering from primary biliary cholangitis (PBC), a type of liver disorder, and with elevated liver stiffness. The drug is being tested for its ability to improve patients’ health over a course of a year. Participants of the study, adults aged 18 years and older, are either not responding adequately or are intolerant to a common PBC treatment, Ursodeoxycholic acid (UDCA). The study employs a randomized double-blind method, meaning patients are randomly placed into groups and neither patients nor researchers know who gets the actual drug or a placebo. The trial will last 52 weeks with an extension phase that could last an additional year. 

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Linz , Austria

      Wels , Austria

      Graz , Austria

      Innsbruck , Austria

      Bruxelles , Belgium

      Laeken , Belgium

      Leuven , Belgium

      Gent , Belgium

      Praha , Czechia

      Hradec Kru00e1lovu00e9 , Czechia

      Lille , France

      Cru00e9teil , France

      Grenoble , France

      Limoges , France

      Vandu0153uvre-lu00e8s-Nancy , France

      Toulouse , France

      Toulouse , France

      Angers , France

      Amiens , France

      Lyon , France

      Lille , France

      Marseille , France

      Nice , France

      Paris , France

      Munich , Germany

      Frankfurt , Germany

      Wiesbaden , Germany

      Hannover , Germany

      Leipzig , Germany

      Homburg , Germany

      Heraklion , Greece

      Larissa , Greece

      Budapest , Hungary

      Milan , Italy

      Rozzano , Italy

      Monza , Italy

      Ancona , Italy

      Messina , Italy

      Milano , Italy

      Napoli , Italy

      Novara , Italy

      Bytom , Poland

      Myslowice , Poland

      Wrocu0142aw , Poland

      Badalona , Spain

      Sabadell , Spain

      La Laguna , Spain

      Alicante , Spain

      Almeru00eda , Spain

      Barcelona , Spain

      Barcelona , Spain

      Cu00f3rdoba , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Mu00e1laga , Spain

      Santiago , Spain

      Sevilla , Spain

      Valu00e8ncia , Spain

      Zaragoza , Spain

      Uppsala , Sweden

      Gloucester , United Kingdom

      London , United Kingdom

      Newcastle upon Tyne , United Kingdom

      Nottingham , United Kingdom

      Sheffield , United Kingdom

      Southampton , United Kingdom

      Glasgow , United Kingdom

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The steps a patient needs to take in this clinical trial involve administering the drug setanaxib as follows:

      1. Participants will take a dose of 1200 mg/day of setanaxib for the initial 52-week double-blind treatment period.
      2. After the initial 52-week, there is a 52-week extension period. Depending on the interim analysis outcome, the dose may be escalated. If a participant is receiving 1200 mg/day, their dose could be escalated to 1600 mg/day for the continued extension period.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you would need to have a diagnosis of definite or probable primary biliary cholangitis (PBC), which is demonstrated by the presence of at least two of the following three diagnostic factors:

      1. Documented history of elevated alkaline phosphatase (ALP) levels at least 1.67 times the upper limit of normal (ULN) of the local reference range.
      2. Documented history of positive antimitochondrial antibodies (AMA) titer or positive PBC-specific antibodies (anti-GP210 or anti-SP100 or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex]).
      3. Historical liver biopsy consistent with PBC.

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      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here is a list of the inclusion criteria for the clinical study along with explanations for medical terms where applicable:

      Inclusion Criteria:

      1. Male or female participant aged 18 years or older at the time of informed consent.
      2. Willing and able to give written informed consent and to comply with the requirements of the study.
      3. A definite or probable diagnosis of primary biliary cholangitis (PBC), as demonstrated by the presence of at least 2 of the following 3 diagnostic factors:
        1. Documented history of elevated levels of alkaline phosphatase (ALP) at least 1.67 times the upper limit of normal (ULN) of the local reference range.
          (ALP) is an enzyme found in the blood that is a marker for bone and liver disease.
        2. Documented history of positive antimitochondrial antibodies (AMA) titer or positive PBC-specific antibodies (antibodies against proteins like GP210 or SP100 or against the major M2 components, which are specific for PBC).
        3. Historical liver biopsy consistent with PBC – A procedure where a small sample of liver tissue is taken to be examined for signs of disease.
      4. Serum ALP level at least 1.67 times the ULN at Screening.
      5. Liver stiffness measured by transient elastography (FibroScan®) of at least 8.8 kilopascals (kPa) and an interquartile range over median ratio (IQR/med) of <=30% at Screening.
        (Liver stiffness) is an indicator of fibrosis or scarring of the liver, with results expressed in kilopascals.
      6. Ursodeoxycholic acid (UDCA) prescription dose use for the past 6 months (at a stable dose for more than 3 months prior to Screening) OR intolerance to UDCA (last dose of UDCA more than 3 months prior to Screening). Intolerance to UDCA is defined as an inability to tolerate the full-labelled dose of UDCA in PBC (13-15 mg/kg) due to gastrointestinal symptoms such as diarrhea and abdominal pain.
        (UDCA) is a medication used to treat certain types of liver disease.
      7. Participants receiving obeticholic acid (OCA), fenofibrate, or bezafibrate treatment for at least 6 months and at stable dose for more than 3 months prior to Screening.
      8. For participants intolerant to OCA, the drug must have been discontinued more than 3 months prior to Screening.
      9. Female participants of childbearing potential must use a highly effective method of contraception to prevent pregnancy for at least 4 weeks before Randomization and must agree to continue strict contraception up to 90 days after the last dose of investigational medicinal product (IMP).
        1. Highly effective contraception includes methods that have a failure rate of less than 1% per year when used consistently and correctly, such as certain hormonal contraceptions, intrauterine devices/systems, bilateral tubal occlusion, vasectomized partner, or sexual abstinence.
      10. Female participants of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Randomization before dosing.
      11. Male participants with female partners of childbearing potential must be willing to use a condom and require their partner to use a highly effective contraceptive method. This requirement begins at the time of informed consent and ends 90 days after receiving the last dose of IMP.
      12. Male participants must be willing not to donate sperm, and female study participants must be willing not to donate eggs, from Baseline until 90 days after the last dose of IMP.

      The inclusion criteria are specifically designed to ensure the safety and efficacy of the clinical trial and proper interpretation of the study results.

      What Reasons Could Exclude Me from the Study?

      Here are the conditions that may exclude you from participating in the study, along with explanations for any medical terms involved:

      1. Pregnancy or Breastfeeding: A positive pregnancy test or breastfeeding if you are a female participant.
      2. Hepatic Decompensation Events: Historical or current serious liver conditions that include variceal bleeding (bleeding from enlarged veins in the digestive tract), hepatic encephalopathy (brain disorder caused by liver disease), spontaneous bacterial peritonitis (infection of the fluid in the abdominal cavity), ascites requiring treatment (accumulation of fluid in the abdomen), or being listed for a liver transplantation.
      3. Liver Transplant History: If you have had a liver transplantation or are currently on a liver transplant list, or if your Model for End-Stage Liver Disease (MELD) score is 12 or higher (unless you are on anticoagulant therapy), or have a Child-Pugh Score of 6 or higher, which are signs of advanced liver disease.
      4. Cirrhosis Complications: Complications from cirrhosis such as hepatocellular carcinoma (a type of liver cancer).
      5. Bilirubin Levels: Total bilirubin higher than twice the upper limit of normal (ULN). Bilirubin is a substance found in bile, and high levels in the blood can indicate liver issues.
      6. Liver Enzymes: Plasma alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than three times the ULN. These enzymes, when elevated, can signal liver damage.
      7. International Normalized Ratio (INR): INR higher than 1.2 unless on anticoagulant therapy. INR is a measure of blood clotting.
      8. eGFR: Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m², indicating kidney function levels.
      9. Thyroid Function: Thyroid-stimulating hormone (TSH) levels above the ULN. TSH controls thyroid gland activity, affecting metabolism.
      10. Other Liver Diseases: Presence of other liver diseases such as hepatitis C (unless cured), active hepatitis B (indicated by HBsAg positive), nonalcoholic steatohepatitis (NASH), and others.
      11. Nonhepatic ALP Increase: Conditions that can cause an increase in alkaline phosphatase (ALP) unrelated to liver disease, such as Paget’s disease.
      12. HIV Infection: Known history of human immunodeficiency virus infection.
      13. Medication Absorption Issues: Any surgery (such as stomach bypass) or medical conditions that might affect the absorption of medications.
      14. Substance Use: Positive urine drug screen unless due to prescribed medication or stable methadone or buprenorphine maintenance treatment for at least 6 months prior to screening.

      Please note that some criteria might allow for re-evaluation under certain conditions, such as being on stable anticoagulant therapy or re-testing at a later screening visit.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The clinical trial involves two drugs—or more accurately, one active drug and a placebo. The list of the drug and its brief description is as follows:

      1. Setanaxib: This is the active drug used in the study. It is being administered in two dosages, 1200 mg/day and 1600 mg/day, with each participant receiving a 52-week double-blind treatment followed by a 52-week extension period. Setanaxib is given as oral tablets, and the dose may be adjusted based on interim analysis outcomes. Setanaxib’s active substance is not specified in the provided document.
      2. Placebo: This is an inactive substance designed to mimic the treatment drug in form without containing the active drug. Participants initially receive a placebo for the 52-week double-blind treatment period, after which they may be switched to active setanaxib depending on the interim analysis outcome.

      There is no information provided in the document about the active substance in setanaxib, so further research would be required to provide those details.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial involves an investigational drug known as Setanaxib. Here is the information about Setanaxib:

      1. Setanaxib: Setanaxib is currently being administered to participants in this clinical trial as an experimental intervention. It is provided as oral tablets with a dosage of 400 mg per tablet. As for the pre-existing knowledge about Setanaxib in the medical literature, since it is being investigated in a clinical trial that includes Phase 2 and Phase 3, it suggests that while Setanaxib may be known and have some existing data from earlier clinical phases, it is not yet established as a standard treatment and is still undergoing evaluation for its efficacy and safety.

      Please note that the fact it is in a clinical trial implies that while there may be some information available from earlier phases of research, it is still being studied to fully understand its effects and potential as a treatment.


      Study ID

      CT-EU-00022687

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      II

      Medicinal Product