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. The medicine has been tested in over 450 individuals and was well tolerated. It is taken orally 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 establish the PLN-74809 safety profile and provide early insights on whether it affects the progression of the disease.
What to expect in the INTEGRIS-PSC clinical trial
The study will consist of:
- Practical visit schedule with monthly visits starting at week 4
- 75% of participants receive active study drug and 25% receive placebo
- Short study duration including:
- 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. You will continue to receive standard of care treatment during the duration of your participation in the clinical trial.
Can I participate?
Talk to your doctor about participating in this clinical trial if:
- If you are an adult patient with confirmed PSC diagnosis
- You have normal or elevated serum alkaline phosphatase concentration ≤10 × upper limit of normal
- 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
Pliant is committed to protecting patients and clinicians from the spread of COVID-19. Our clinical trial sites are following all government and institutional safety guidelines. Pliant will continue to work closely with site investigators and update our practices accordingly to ensure the safe continuation of the trial.