Phase 2 Primary Biliary Cholangitis Trial, Not Yet Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years old or older
• You are willing to use at least one reliable form of birth control (such as hormonal contraceptives, an IUD, a double-barrier method, or surgical sterilization) during the study and for 30 days after your last dose — or you are a woman who has gone through menopause (no periods for 12 months or more, or at least 6 weeks after having both ovaries removed)
• You have been diagnosed with Primary Sclerosing Cholangitis (PSC), a condition affecting the bile ducts in the liver
• Your blood test shows a liver enzyme called alkaline phosphatase (ALP) is more than twice the normal upper limit
• A specialist scan (MRCP or ERCP) taken within the last 6 months has confirmed scarring or narrowing in multiple bile ducts
• You are able to understand what the study involves and can give written consent to take part

Who may not be able to join:

• You drink an average of more than 20 grams of alcohol per day (roughly 1.5 standard drinks) over the past 2 years
• You have been diagnosed with type 1 diabetes, or type 2 diabetes that is not well controlled (confirm with trial site)
• You have another chronic liver disease besides PSC, such as fatty liver disease, viral hepatitis, alcoholic liver disease, or others
• You have been diagnosed with primary biliary cholangitis or secondary sclerosing cholangitis (a related but different bile duct condition)
• You cannot have an MRCP scan — for example, if you have a pacemaker, a metal implant in your eye, a clipped brain aneurysm, or severe claustrophobia
• Your blood tests show certain liver enzymes (ALT or AST) are more than 5 times the normal upper limit
• Your blood test shows a kidney marker called creatinine is at 2 mg/dl or higher, suggesting reduced kidney function
• You have cirrhosis, severe metabolic disease, severe kidney failure, severe lung disease, severe nerve or mental health conditions, or muscle disease (as judged by the study doctor)
• You have any significant heart or cardiovascular disease
• You have an uncontrolled thyroid condition — though if your thyroid condition has been stably managed for at least 6 months, you may still be eligible (confirm with trial site)
• You have a history of certain immune system diseases such as lupus, rheumatoid arthritis, or severe psoriasis — though mild or well-managed atopic dermatitis (eczema) may be acceptable (confirm with trial site)
• You had weight-loss (bariatric) surgery within the 6 months before the study screening
• You have already had a liver transplant, are waiting for one, or have advanced end-stage liver disease
• Your screening blood tests come back positive for HIV, hepatitis B, or hepatitis C
• You have a history of serious or ongoing infections, or currently have symptoms like fever or cough — though people with mild-to-moderate inflammatory bowel disease (IBD) that is well controlled may be eligible (confirm with trial site)
• You have an active infection at the time of screening
• You have been diagnosed with cancer that was not fully cured within the past 5 years
• You have recently taken certain medications that may affect the liver or are related to PSC treatment, including high-dose vitamin E, certain immunosuppressants, or others — the study team will review your medication history in detail (confirm with trial site)
• You have taken herbal medicines or folk remedies for liver conditions within the 2 weeks before screening
• You have a history of alcohol or drug abuse within the past 5 years
• You have a known allergy or sensitivity to any ingredients in the study drug
• You have taken part in another drug trial within the 30 days before screening
• The study doctor has another reason to consider you unsuitable for the trial (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.