Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Primary Biliary Cholangitis

In brief

Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.

Key facts

Study ID

NCT06247735

Run by

Kowa Research Institute, Inc.

People needed

46

Starts

2024-02-07

Expected to finish

2026-07-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Historical liver biopsy consistent with PBC
• Participant has the following qualifying biochemistry value at Screening:
• ALP ≥1.5 × ULN
• Participant is ≥18 years of age at consent.
• Participant meets all other eligibility criteria outlined in the Clinical Study Protocol.

You may not qualify if…

• Participant meets any one of the following criteria at Screening:
• ALP>10 × ULN
• ALT or AST >5 × ULN
• Hepatitis C treatment within 5 years of Screening, or active hepatitis C as defined by positive hepatitis C antibody with the presence of hepatitis C virus ribonucleic acid; subjects with active hepatitis B (HBV) infection (hepatitis B surface antigen [HbsAg] positive) will be excluded. A subject with resolved hepatitis A at least 3 months prior to the Screening Visit can be screened.
• Primary sclerosing cholangitis and secondary sclerosing cholangitis (eg, due to cholangiolithiasis, ischemia, telangiectasia, vasculitis, infectious diseases)
• Alcoholic liver disease
• History of definite autoimmune hepatitis or PBC/autoimmune hepatitis overlap, defined as both of the following: 1) IgG >2 × ULN and/or positive anti-smooth muscle antibodies, 2) liver histology revealing moderate or severe periportal or periseptal inflammation
• Nonalcoholic steatohepatitis (NASH)
• Gilbert's Syndrome
• Alpha-1-antitrypsin deficiency, cystic fibrosis, Wilson's disease, hemochromatosis based on historically established diagnosis
• Drug-induced liver injury (DILI) as defined by typical exposure and history
• Known condition that involves bile duct obstruction or cholestasis other than PBC, eg, vascular diseases (eg, Budd-Chiari syndrome, sinusoidal obstruction syndrome, congestive hepatopathy), congenital conditions (ductal plate malformations, Caroli syndrome, congenital liver fibrosis), idiopathic ductopenia
• Hepatocellular carcinoma
• Participant meets any other exclusion criteria outlined in the Clinical Study Protocol.

Where it is running

• UA Thomas D. Boyer Liver Institute — Tucson, Arizona, United States
• Southern California Research Center - Coronado — Coronado, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Velocity Clinical Research — Santa Ana, California, United States
• Peak Gastroenterology Associates Colorado Springs — Colorado Springs, Colorado, United States
• University of Florida Hepatology Research at CTRB — Gainesville, Florida, United States
• Florida Research Institute — Lakewood Rch, Florida, United States
• University of Miami Leonard M. Miller School of Medicine — Miami, Florida, United States
• Springfield Clinic — Springfield, Illinois, United States
• Mercy Medical Center - Mcauley Plaza — Baltimore, Maryland, United States
• CommonSpirit Health Research Institute — Omaha, Nebraska, United States
• New York University Hepatology Associates — New York, New York, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Einstein Medical Center — Philadelphia, Pennsylvania, United States
• Rapid City Medical Center — Rapid City, South Dakota, United States
• Vanderbilt Digestive Disease Center — Nashville, Tennessee, United States
• Pioneer Research Solutions — Houston, Texas, United States
• UVA Health - University of Virginia Health System — Charlottesville, Virginia, United States
• Gastrointestinal and Liver Specialists of Tidewater - Digestive and Liver Disease Specialists — Norfolk, Virginia, United States
• Liver Institute Northwest — Seattle, Washington, United States
• (G.I,R,I) GI Research Institute — Vancouver, British Columbia, Canada
• Office of Dr. Gauthier — North Bay, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM) — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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