The purpose of this study is to determine the safety and effectiveness of an experimental drug called K-808 in participants with primary biliary cholangitis (PBC). K-808 (also called K-877-ER or pemafibrate) is designed to slow down the worsening of PBC and help improve disease symptoms. The medication is also expected to lower the level of a liver enzyme, alkaline phosphatase, in the blood. K-808 works by joining onto a protein found in the body’s cells and may also reduce inflammation. Participants will be randomly assigned to 1 of 4 groups. The first group will receive placebo (inactive substance) for 12 weeks, then K-808 at .02 mg for 52 weeks. The second group will receive placebo for 12 weeks, then K-808 at .04 mg for 52 weeks. The third group will receive K-808 at .02 mg for 12 weeks, then continue with K-808 at .02 mg for 52 weeks. The fourth group will receive K-808 at .04 mg for 12 weeks, then continue with K-808 at .04 mg for 52 weeks. Participants will also be asked to complete blood draws, electrocardiograms, imaging (such as liver ultrasounds), urine collections, and fasting.
What is the full name of this clinical trial?
A Phase 2, Randomized, Placebo-controlled, Parallel Group, Multicenter 12-week Study with a 52-week Extension to Evaluate the Efficacy and Safety of Two Doses of K-808 in Subjects with Primary Biliary Cholangitis with Inadequate Response to Ursodeoxycholic Acid and/or Obeticholic Acid Treatment