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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 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.
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 health care for people in the future, such as evaluating the safety and efficacy of an investigational drug for a disease or condition. The results of clinical studies help regulatory agencies like the U.S. Food and Drug Administration (FDA) to decide if an investigational drug works and is safe. Clinical trials offer a chance to help researchers find better treatments for others in the future.

Clinical trials are divided into 4 different phases:

Every clinical study is reviewed by an independent review board or ethics committee (IRB or EC), who helps 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 for the development of new therapies. Clinical studies offer a chance to help researchers find better treatments for others in the future.
What is the purpose of the PRIMIS study?

This study is testing an investigational drug called cilofexor in 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. 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

PRIMIS is a phase 3 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:

  • 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 experimental drug (cilofexor) or a placebo (an inactive substance). You have a 1 in 3 chance of receiving the 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.

Take a quick survey & learn if you qualify now.

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 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.

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. The sites will be listed in order of closest to furthest based on the zip code entered. 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 the 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 answering 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 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 additional information about the study. To find out if there is a study center near you, please enter your Zip / Postal code.

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You may be paid for study-related time and reimbursed for your travel expenses. The study staff will provide more information about any possible compensation.

Please contact a participating study site of your choice to further determine if you may qualify:

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 study drug, clinic visits, laboratory tests, and procedures that are part of the study will be provided at no cost. You and/or your usual health care payer will be responsible for any other health care costs. You may be paid for study-related time and reimbursed for your travel expenses. The study staff will provide more information about any possible compensation.
No. 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.
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.
Yes. We are currently conducting a Phase I study in the United States. Please use the link below to access additional information: https://clinicaltrials.gov/ct2/show/NCT04060147

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