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

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 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Inadequate Response to Ursodeoxycholic Acid and/or Obeticholic Acid Treatment

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071230106

Enrollment

Registered

2024-01-18

Start date

2024-01-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Biliary Cholangitis

Interventions

-Placebo for 12 weeks followed by K-808 (DoseA) for 52 weeks: administrated orally once daily -Placebo for 12 weeks followed by K-808 (DoseB) for 52 weeks: administrated orally once daily -K-808 (Dose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: -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; participant with active hepatitis B (HBV) infection (hepatitis B surface antigen [HbsAg] positive) will be excluded. A participant 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-smoothmuscle antibodies and 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 confirmed 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.

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in serum ALP after 12 weeks of treatment	—

Countries

Canada, Japan, United States

Contacts

Public Contact- Contact for clinical trial information

Kowa Company, Ltd.

ctrdinfo@kowa.co.jp+81-3-3279-7454

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026