K-808 (Pemafibrate) in Primary Biliary Cholangitis

What is the Purpose of this Study?

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.


Eligibility

  • * Male or female participant who has a PBC diagnosis as demonstrated by the presence of ≥2 of the following three diagnostic criteria:
  • * History of ALP above ULN for at least 6 months
  • * History of positive antimitochondrial antibody (AMA) titer or positive PBC-specific antinuclear antibody (ANA) titer
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Where can I participate?

Beverly

More about this Clinical Trial

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

Study Details
Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Co-Investigators

Walid Ayoub

Age Group

Adult

Phase

II

IRB Number

STUDY00003295

ClinicalTrials.gov ID

NCT06247735

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

II

IRB Number

K-808-2-01

ClinicalTrials.gov ID

NCT06247735

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org