The RESPONSE Clinical Research Study

STUDY BASICS

Do you have a diagnosis of primary biliary cholangitis (PBC)? Are you aged 18-75? You may be able to participate in a research study to help find out if an investigational drug called seladelpar is a safe and effective treatment for people with PBC. Eligible participants have either been on a stable dose of ursodeoxycholic acid (UDCA or ursodiol) for the past 12 months or cannot tolerate UDCA.

STUDY PURPOSE

Primary biliary cholangitis (PBC) is a rare autoimmune disease of the liver. Although many people with PBC do not initially have symptoms, ongoing liver damage often causes excessive scarring called fibrosis. Over time, as scar tissue replaces healthy liver tissue, fibrosis can progress to cirrhosis—a serious condition that increases the risk of liver failure and liver cancer.

 

The purpose of this study is to find out if an investigational drug called seladelpar is a safe and effective treatment for people with PBC. Previous studies have shown that seladelpar may help lower an enzyme associated with the disease and decrease the itching some PBC patients experience. 

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 18-75
• Diagnosed with primary biliary cholangitis (PBC)
• Have been on a stable dose of ursodeoxycholic acid (UDCA) for the past 12 months or stopped taking UDCA due to side effects

WHAT PARTICIPANTS CAN EXPECT

Participants will be randomly assigned (like the flip of a coin) to receive either seladelpar or placebo (the placebo looks like seladelpar but contains no active ingredients) once per day by mouth for 52 weeks. If you are currently taking UDCA, you will continue to take your UDCA during study participation. Study procedures include questionnaires, physical exams, ultrasound, electrocardiogram, optional biopsies, and other tests and assessments.