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 between 18 and 70 years old (any gender).
• You have been diagnosed with Atopic Dermatitis (a chronic skin condition causing itchy, inflamed skin) that has lasted more than 6 months, is present on both sides of the body, AND either you or a close family member has a history of allergic conditions (such as eczema, hay fever, or asthma), OR certain blood/allergy test results are abnormal.
• You have moderate-to-severe itching, rated 4 or higher on a scale of 0–10.
• You have been diagnosed with Primary Biliary Cholangitis (PBC, a liver condition), meeting at least two of these: abnormal liver enzyme blood tests, a positive result for specific antibodies in the blood, or liver tissue showing signs of the disease (confirm with trial site).
• For PBC: you have been taking the standard medication ursodeoxycholic acid (UDCA) for at least 12 months, plus at least two other additional treatments for at least 3 months, and your liver enzyme levels are still significantly above normal at the screening visit.
• You have been diagnosed with Primary Sclerosing Cholangitis (PSC, another liver condition) confirmed by imaging and/or liver tissue testing, with other causes ruled out.
• For PSC: you have been taking UDCA for at least 3 months, and your liver enzyme levels are still significantly above normal at the screening visit.

Who may not be able to join:

• You have, or have had, another liver or bile duct disease, such as active hepatitis B or C, a blocked bile duct, acute gallbladder inflammation, gallstones causing symptoms, or liver or bile duct cancer.
• You have severe (Class C) liver cirrhosis, have had a liver transplant, are on a transplant waiting list, have a high liver disease severity score (MELD score above 20), or have serious complications from cirrhosis such as severe varicose veins in the food pipe or stomach, fluid buildup resistant to treatment, or other major liver-related complications.
• Your bilirubin (a substance measured in blood that indicates liver function) is more than 10 times the upper limit of normal.
• Your kidney function tests show your kidneys are not working well enough (confirm with trial site).
• Your platelet count (cells that help blood clot) is too low.
• Your blood clotting test (INR) result is above 1.5, suggesting your blood does not clot normally.
• Your blood protein (albumin) level is below 3.0 g/dL, suggesting poor nutrition or liver function.
• You are currently taking, or plan to take, certain medications that strongly affect how the body processes drugs (CYP3A4 inhibitors or inducers — confirm with trial site which medications this includes).
• You have a condition unrelated to the liver that could cause abnormal enzyme results, or a condition where your life expectancy is less than 2 years.
• You have had a drug or alcohol problem in the last 6 months, or you regularly drink more than 14 standard alcoholic drinks per week.
• You have other unstable health conditions or are taking medications that cannot remain at a steady dose throughout the study.
• You are pregnant, planning to become pregnant, breastfeeding, or you are unwilling to use at least one reliable form of contraception from the time you join the study until 30 days after your last dose.
• You have taken part in another clinical trial or received an experimental treatment within the last 3 months.
• You have tested positive for HIV or syphilis.
• The trial doctors decide for any other reason that the study would not be appropriate for you.

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