TRANSFORM: A 52-week Randomized Placebo-controlled Double-blind Adaptive Phase 2b/3 Trial of Setanaxib with a 52-week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Primary Biliary Cholangitis
  • Age: Between 18 Year(s) - 120 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Willing and able to give written informed consent and to comply with the requirements of the study.
    2. Ursodeoxycholic acid (UDCA) prescriptional dose use for the past 6 months (at a stable dose for >3 months prior to Screening) OR intolerant to UDCA (last dose of UDCA >3 months prior to Screening).
    3. For patients receiving obeticholic acid (OCA), fenofibrate, or bezafibrate treatment for at least 6 months and stable dose for >3 months prior to Screening.
    4. For patients intolerant to OCA, OCA must have been discontinued >3 months prior to Screening.
    5. For patients previously treated with bezafibrate or fenofibrate, these agents must have been be discontinued >3 months prior to Screening.
    6. Female patients of childbearing potential must use a highly effective method of contraception to prevent pregnancy for =4 weeks before Randomization and must agree to continue strict contraception up to 90 days after the last dose of investigational medicinal product (IMP).
    7. Male patients with female partners of childbearing potential must be willing to use a condom and require their partner to use an additional form of adequate contraception.
    8. Male patients 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.

You may not be eligible for this study if the following are true:

    1. A positive pregnancy test or breastfeeding for female patients.
    2. Any historical or current hepatic decompensation event defined as variceal/portal hypertension bleed and/or hepatic encephalopathy, spontaneous bacterial peritonitis, ascites requiring treatment, or liver transplantation list inclusion.
    3. History of liver transplantation, current placement on a liver transplant list.
    4. Cirrhosis with complications, including history or presence of hepatocellular carcinoma.
    5. Known history of HIV infection.
    6. Positive urine drug screen (if not due to prescriptional use of a concomitant medication, as confirmed by the Investigator) at Screening.
    7. Treatment or planned treatment, with a pacemaker, implanted cardioverter-defibrillator, or other implanted electronic device.
    8. History of a malignancy within 5 years of Screening with the following exceptions:
      • a. Adequately treated carcinoma in situ of the cervix
      • b. Adequately treated basal or squamous cell cancer or other localized nonmelanoma skin cancer.
    9. A history of bone marrow disorder including aplastic anemia.
    10. Prior treatment with setanaxib or participation in a previous setanaxib clinical trial.
    11. Unstable cardiovascular disease as defined by any of the following:
      • Unstable angina within 6 months prior to Screening.
      • Myocardial infarction, coronary artery bypass graft surgery, or coronary angioplasty within 6 months prior to Screening.
      • Cerebrovascular accident within 6 months prior to Screening.
      • New York Heart Association Class III or IV heart failure.

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