Primary Sclerosing Cholangitis (PSC) Clinical Trials

Primary Sclerosing Cholangitis is characterized by progressive fibro-inflammatory destruction of bile ducts, leading to stricturing and cholestasis. The pathophysiology remains incompletely understood but likely involves aberrant immune response to bile ducts, possibly triggered by microbial antigens or damage-associated molecular patterns. Intestinal dysbiosis and increased bacterial translocation appear to play roles.

The most common symptoms of Primary Sclerosing Cholangitis include Fatigue and malaise, Pruritus and skin itching, Jaundice with yellowing of skin and eyes, Abdominal pain and discomfort, Cholangitis with fever, right upper quadrant pain, and jaundice, among others. About 13.5 per 100,000 people in a 2024 pooled analysis of 12 population studies from North America, Europe, Asia and Oceania, with about 0.9 new cases per 100,000 people a year (Cooper et al., Inflamm Bowel Dis 2024); higher in Scandinavian countries; associated with IBD in 50-80% of PSC patients. Symptoms can range from mild to severe and may vary between individuals.

Trial Friend lists all active clinical trials for Primary Sclerosing Cholangitis from ClinicalTrials.gov, with eligibility criteria translated into plain English. Patients can filter by trial phase and recruitment status, search by location, and use the Match Me tool to score trials against their profile. Research in Primary Sclerosing Cholangitis focuses on slowing the bile duct scarring that eventually leads to liver failure, and on easing itch. Studies on ClinicalTrials.gov test norucholic acid in a Phase 3 trial (NCT06886360), oral vancomycin and fecal microbiota transplants aimed at gut bacteria, and fenofibrate to keep PSC from returning after a liver transplant.

As of October 21, 2026, no current FDA drug label names Primary Sclerosing Cholangitis as a condition the drug treats.

The exact cause of Primary Sclerosing Cholangitis is not fully understood. It is not caused by a single gene; inherited variants raise risk, and immune, environmental or other triggers are thought to set it off. Cause is unknown; genes, immune dysfunction and the gut microbiome are thought to contribute, and no diagnostic gene test exists. About 13.5 per 100,000 people in a 2024 pooled analysis of 12 population studies from North America, Europe, Asia and Oceania, with about 0.9 new cases per 100,000 people a year (Cooper et al., Inflamm Bowel Dis 2024); higher in Scandinavian countries; associated with IBD in 50-80% of PSC patients. Research is ongoing to better understand the disease mechanism.

No single gene test diagnoses Primary Sclerosing Cholangitis. The diagnosis rests on clinical findings and laboratory or imaging results; genetic variants shift risk rather than cause the disease. Cause is unknown; genes, immune dysfunction and the gut microbiome are thought to contribute, and no diagnostic gene test exists.

Some trials collect genetic samples for research or check specific risk markers. The Genetic Testing section of this page shows any tests listed in the NIH Genetic Testing Registry, which for this condition are usually research or risk-marker tests rather than diagnostic ones.

Eligibility for Primary Sclerosing Cholangitis clinical trials depends on factors like age, diagnosis, treatment history, and overall health. Each trial sets its own inclusion and exclusion criteria. Trial Friend translates these requirements from medical language into plain English so patients can review them more easily. The Match Me tool can score your profile against active trials to help identify studies that may be a fit.

Participating in a Primary Sclerosing Cholangitis clinical trial typically involves scheduled visits, medical tests, and close monitoring by a research team. Depending on the study phase, you may receive an investigational treatment, a placebo, or the current standard of care. Trials may last from a few weeks to several years. Study participation is voluntary, and you can withdraw at any time.