RESPONSE: A Placebo-controlled Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

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 - 75 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants must provide written informed consent
    2. Male or female with a diagnosis of PBC based on any two of the following criteria:
      • History of ALP above 1.0× ULN for at least 6 months
      • Positive AMA titeror positive PBC-specific antinuclear antibodies
      • Documented liver biopsy results consistent with PBC
    3. UDCA for the past 12 months (stable dose for >3 months prior to screening) OR intolerant to UDCA (last dose of UDCA >3 months prior to screening)
    4. Laboratory parameters measured by the Central Laboratory at screening
    5. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose

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

    1. Previous exposure to seladelpar (MBX-8025)
    2. A medical condition other than PBC that, in the investigator’s opinion, would preclude full participation in the study (eg, cancer) or confound its results
    3. Advanced PBC as defined by the Rotterdam criteria
    4. Presence of clinically important hepatic decompensation including the following:
      • History of liver transplantation, current placement on liver transplantation list
      • Complications of portal hypertension
      • Cirrhosis with complications
    5. Other chronic liver diseases:
      • Current features of autoimmune hepatitis
      • Primary sclerosing cholangitis
      • History or clinical evidence of alcoholic liver disease
      • History or clinical evidence of alpha-1-antitrypsin deficiency
      • History of biopsy confirmed NASH
      • History or evidence of Gilbert’s syndrome with elevated total bilirubin
      • History or evidence of hemochromatosis
      • Hepatitis B
      • Hepatitis C
      • History, evidence, or high suspicion of hepatobiliary malignancy
    6. Known history of human immunodeficiency virus (HIV) or positive antibody test at screening
    7. Clinically important alcohol consumption
    8. History of malignancy diagnosed or treated, actively or within 2 years, or ongoing evaluation for malignancy; localized treatment of squamous or noninvasive basal cell skin cancers and cervical carcinoma in situ is allowed if appropriately treated prior to screening
    9. Treatment with OCA, fibrates 3 months prior to screening
    10. Treatment with colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids (>2 weeks) during 2 months prior to screening
    11. Treatment with anti-pruritic drugs
    12. Treatment with any other investigational therapy or device within 30 days or within 5 half-lives, whichever is longer, prior to screening
    13. For females, pregnancy or breastfeeding
    14. Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the investigator
    15. Immunosuppressant therapies
    16. Other medications that effect liver or GI functions, such as absorption of medications, may be prohibited and should be discussed with the medical monitor on a case-bycase basis

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