Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects With Primary Biliary Cholangitis (PBC)

Korábbi kezelés

• Previous exposure to seladelpar (MBX-8025).
• Treatment with obeticholic acid or fibrates 6 weeks prior to screening.
• Treatment with colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids within 2 months prior to screening.
• Initiation or dose adjustment of anti-pruritic drugs indicated for the treatment of pruritus within 1 month prior to screening.
• Immunosuppressant therapies within 6 months prior to screening.
• Other medications that affect liver or gastrointestinal functions, as well as the roux-en-y gastric bypass procedure, may be prohibited and should be discussed with the medical monitor on a case by-case basis.
• Treatment with any other investigational therapy or device within 30 days or within halflives, whichever is longer, prior to screening.

Más betegség

• 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.
• Other chronic liver diseases.
• Known history of human immunodeficiency virus (HIV) or positive antibody test at screening.
• History of malignancy diagnosed or treated, active 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.
• History of drug abuse that would compromise the quality of the clinical study.
• Any other condition(s) that would compromise the safety of the individual or compromise the quality of the clinical study, as judged by the investigator.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Laborértékek

• Laboratory parameters measured by the Central Laboratory at screening.

Egyéb

• Advanced PBC as defined by the Rotterdam criteria.
• Clinically important hepatic decompensation.
• Clinically important alcohol consumption, defined as more than 2 drink units per day in women and 3 drink units per day in men, or inability to quantify alcohol intake reliably.
• Pregnancy or plans to become pregnant, or breastfeeding.

• Individuals must meet the following criteria to be eligible for study participation:
• Male or female with a diagnosis of primary biliary cholangitis (PBC) based on history.
• Ursodeoxycholic acid (UDCA) for the 12 months prior to screening (with stable dose for > 3 months prior to screening) OR intolerant to UDCA (last dose of UDCA > 3 months prior to screening).
• ALP > 1× ULN and < 1.67× ULN.
• 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 participants 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.