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:

• Adults between 18 and 75 years old (men or women) at the time of signing the consent form.
• People diagnosed with Primary Biliary Cholangitis (PBC), confirmed by at least 2 of the following: a long-term history of raised liver enzyme levels (for at least 6 months), certain positive antibody blood test results, or a liver biopsy consistent with PBC.
• People whose liver enzyme level (ALP) is not extremely high — specifically below 10 times the upper limit of the normal range.
• People already taking certain liver or itch-related medications (such as UDCA, obeticholic acid, elafibranor, seladelpar, fibrates, cholestyramine, or antihistamines), as long as the dose has been stable for more than 12 weeks before the screening visit.
• People who experience noticeable itching (pruritus), with a worst daily itch score above 4 out of 10, both at the screening visit and on at least 4 days during a 1-week observation period before the trial starts.
• Women who are not pregnant or breastfeeding, and who either cannot become pregnant (e.g., post-menopausal or have had a tubal ligation or hysterectomy) or who agree to use effective birth control during the study.
• Men with female partners who agree to use effective birth control throughout the study.
• People who are able to understand and sign the consent form and follow the study requirements.

Who may not be able to join:

• People with certain blood test results at screening that are too high, including: bilirubin more than 2 times the normal upper limit, liver enzymes ALT or AST more than 4 times the normal upper limit, or creatinine (a kidney marker) above a certain level.
• People who have had serious liver complications such as internal bleeding from swollen veins, confusion caused by liver failure (encephalopathy), or poorly controlled fluid build-up in the abdomen (ascites).
• People who have other liver conditions alongside PBC, such as hepatitis B or C, primary sclerosing cholangitis, alcoholic liver disease, autoimmune hepatitis, or a certain type of fatty liver disease.
• People whose thyroid hormone levels are outside the normal range.
• People who have taken certain medications in the 3 months before screening, including colchicine, methotrexate, azathioprine, opioids, opioid blockers, or steroid tablets.
• People with a history of inflammatory bowel conditions such as Crohn's disease, chronic diarrhoea, or diarrhoea related to the body not absorbing nutrients properly.
• People with certain abnormal heart rhythm readings on an ECG (electrocardiogram) (confirm with trial site).
• People with a known allergy or sensitivity to any of the study medications or their ingredients.
• People who have been regularly drinking more alcohol than recommended — more than 21 units per week for men or 14 units per week for women — in the 6 months before screening.
• People who test positive for drugs or alcohol at screening (including amphetamines, cocaine, opiates, cannabis, barbiturates, or benzodiazepines).
• People for whom taking part would require more than 500 mL of blood to be taken within any 56-day period.
• People who have taken sertraline (an antidepressant) or rifampicin (an antibiotic) within 4 weeks before the screening visit.
• People with a significant problem affecting the lining of the mouth (cheek area) that could affect how the study drug is absorbed.
• People who have taken part in another clinical trial with an experimental treatment recently (within 30 days or longer, depending on the treatment) before this study begins.
• People with advanced (decompensated) liver disease, including those with a high Child Pugh score (above 10) (confirm with trial site).

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