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You live with Primary Sclerosing Cholangitis every day.
We need your help now to find potential treatments.
Learn about the PRIMIS study on cilofexor (GS-9674), an investigational drug for PSC.
Cilofexor is an investigational medicinal product and its safety and efficacy have not been established. There is no guarantee that the investigational product will be filed with or approved by any regulatory agency.
What is Primary Sclerosing Cholangitis (PSC)?

PSC is a chronic disease which causes scarring of the bile ducts. When 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.

What is a clinical research study?

A clinical research study (also known as a clinical trial) is designed to help medical research learn more about disease and improve healthcare for people in the future, by evaluating the safety and efficacy of an investigational medicinal product for a disease or condition. The results of clinical studies help regulatory agencies to decide if an investigational medicine works and is safe to use. Clinical trials offer a chance to help researchers find better treatments for people in the future.

This is a Phase 3 Study. Clinical trials are divided into 4 different phases:

Every clinical study is reviewed by an independent review board (IRB) or an ethics committee (EC), both of which ensure that the study is conducted safely and that the rights and safety of study participants are protected. Clinical trials are conducted by medical professionals who monitor the health of participants during the study.

Every day, research uncovers new information about medical conditions and their treatment. The involvement of patient volunteers in clinical research studies is critical in the development of new therapies. Clinical studies offer a chance to help researchers find better treatments for people in the future.
What is the purpose of the PRIMIS study?

This study is testing an investigational medicinal product called cilofexor in adults with primary sclerosing cholangitis (PSC) to see if it can potentially slow the progress of liver scarring caused by PSC. PSC is a chronic disease which causes scarring of the bile ducts. When 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 a broader population of patients with PSC.

About the PRIMIS study

Participation in the study will last about 2 years and will require approximately 14 visits to the research clinic and multiple, regularly scheduled phone calls.

The study is divided into several phases:

  • Screening Period (about 2 months): Tests will be carried out to determine if you can enrol in the study and adjustments may be made to your current medication. 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 clinical study treatment with either the investigational medicine ( cilofexor) or a placebo (an inactive substance). Participants have a 1 in 3 chance of receiving the placebo. You'll need to visit the study clinic once every 1-3 months for health checks and study procedures. You'll also receive regularly scheduled calls from the study clinic to check on your health.
  • Follow-Up Period: About 4 weeks after the Study Treatment Period ends, you'll need to visit one last time for a check-up on your health and any potential side effects.

Take a quick survey now & find out if you qualify.

Who can participate in the PRIMIS study?

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 a current or prior history of cirrhosis, liver transplant, bile duct cancer, other cancer within the last 5 years, or unstable cardiovascular disease
  • Do not currently have 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.

Please answer the questions below to help us determine if you may qualify for the PRIMIS clinical research study for primary sclerosing cholangitis (PSC). You must be between 18-75 years of age to complete this survey. If your responses indicate that you may qualify, you will be provided with contact information of a study site within your chosen radius. Prequalification on this website does not guarantee your eligibility to participate in the study. Additional qualification criteria exist. Study site staff will answer any questions you may have and will discuss next steps to determine whether you may qualify for this study.

What will happen to my information? The information you provide will not be stored. By providing answers on this form, you are agreeing to provide permission to the host of this website to use your information for the purposes of determining whether you may qualify for the PRIMIS study for primary sclerosing cholangitis. For more information, please see our Data Protection & Privacy policy

Start the survey

Thank you for your interest.

Based on your answers, you do not currently qualify to participate in the PRIMIS study for primary sclerosing cholangitis.

Finished survey

Thank you for taking the time to complete the study questionnaire. Based on your responses, it looks like you prequalify to be provided with additional information about the study. To find out if there is a study site near you, please enter below your postal code and the maximum distance you will travel.

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Maximum distance in miles (km) I will travel

Frequently Asked Questions

Taking part in the PRIMIS study is completely voluntary. Participation is not required, and if enrolled, you can choose to end participation at any time and for any reason.
The investigational product, clinic visits, laboratory tests and procedures that are part of the study will be provided at no cost. You and/or your usual healthcare payor will be responsible for any other healthcare costs. You may be reimbursed for your travel expenses.
No. Cilofexor is an investigational medicinal product and its safety and efficacy have not been established. There is no guarantee that the investigational product will be filed with or approved by any regulatory agency.
For additional information about the study, please visit www.clinicaltrials.gov. To find out if you may be eligible and to find a study center near you, click here.

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