The INTEGRIS-PSC clinical trial is studying PLN-74809, an oral investigational medicine designed to directly target the development of liver fibrosis (when tissue becomes damaged and scarred, affecting normal function of the organ) in patients with primary sclerosing cholangitis, or PSC. It is taken once per day for 12 weeks.
By stopping the cellular process that causes fibrosis, PLN-74809 may have the potential to slow or stop the progressive decline in liver function that happens with PSC. This study will help determine if PLN-74809 affects worsening of the disease and improves quality of life.
What to expect in the INTEGRIS-PSC clinical trial
The study will consist of:
- A screening period, up to 42 days
- A treatment period of 12 weeks
- A follow-up period of 4 weeks
During the study period, you will have a total of eight visits so that several measurements of liver function can be made. Some of these visits will be on site with your doctors. At-home option: If you and your doctor agree, a study nurse may come to your home to conduct a portion of the required appointments.
Can I participate?
Talk to your doctor about participating in this clinical trial if:
- If you are an adult patient with confirmed PSC diagnosis
- Your alkaline phosphatase level is 1.5 X ULN
- You do not have cirrhosis
Patients with small duct PSC, overlapping autoimmune hepatitis or bile duct stents are not eligible for the study.
In addition to your PSC, if you are currently being treated for Inflammatory Bowel Disease (IBD), you may enroll in this trial and continue your IBD medication throughout the duration of the trial. If you are being treated with UDCA, you are eligible for this study.
- The trial is open to women and men
- The trial will include 60 study sites across the U.S. and the rest of the world
We are committed to protecting patients and clinicians from the spread of COVID-19. Our clinical trial sites are following all government and institutional safety guidelines.
Additionally, we are minimizing participants’ visits to trial sites by offering home-health solutions – with some tests and measures conducted through telehealth appointments in participant homes.
Pliant Therapeutics will continue to work closely with site investigators and update our practices accordingly to ensure the safe continuation of the trial.