Slow the Progress of Liver Damage caused by PSC

What is the purpose of the PRIMIS study?

This study is testing an investigational drug called cilofexor in non-cirrhotic adults with primary sclerosing cholangitis (PSC) to see if it can potentially slow the progress of liver scarring (fibrosis) caused by PSC. PSC is a chronic disease which causes scarring of the bile ducts. Then the bile ducts are damaged, the ducts become hard and narrow and this can block the flow of bile which can cause damage to the liver over time. Around 400 people will participate in the study at about 200 study clinics around the world. The PRIMIS study will help evaluate the safety and effectiveness of cilofexor in patients with PSC.

Cilofexor is an investigational agent and its safety and efficacy have not been established. There is no guarantee that the investigational agent will be filed with or approved by any regulatory agency.

About the study:

Participation in the study will last about 2 years and will require approximately 13 visits to the research clinic.

The study is divided into several phases: All study-related visits, tests, and study medications will be provided to participants at no cost by the biopharmaceutical company sponsoring this clinical trial.

  • Screening Period (about 2 months): Tests will be performed to determine if you can enroll in the study and adjustments may be made to current medications. You may need to have a liver biopsy performed if you have not had one within the last 6 months.
  • Study Treatment Period (about 22 months): You will be randomly assigned (like the flip of a coin) to study treatment with either the investigational drug (cilofexor) or placebo (an inactive substance). You have a 1 in 3 chance of receiving placebo. You will return to the study clinic every 1-3 months for health checks and study procedures.
  • Follow-Up Period: You will have one last visit about 4 weeks after the Study Treatment Period ends to check on your health and any potential side effects.

Eligibility Criteria

You may qualify to participate if you:

  • Are 18 to 75 years of age
  • Have been diagnosed with large duct PSC (a specific type of PSC)
  • Do not have current or prior history of cirrhosis, liver transplant, bile duct cancer, cancer within the last 5 years, or unstable cardiovascular disease
  • Do not have currently active inflammatory bowel disease (IBD) that is considered moderate to severe; examples of IBD include ulcerative colitis and Crohn’s disease

Other criteria will be reviewed to determine if you qualify for this study.

How Do I Get Involved?

If you feel you are interested in participating in the PRIMIS clinical study, please contact Jessie Covell at (318) 525-3237 to determine if the trial is right for you.