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.

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

February 7, 2024

Primary Completion Date

June 26, 2025

Study Completion Date

June 30, 2026

Conditions
Primary Biliary Cholangitis
Interventions
DRUG

K-808 (Dose A)

Administered orally once daily

DRUG

K-808 (Dose B)

Administered orally once daily

DRUG

Placebo

Administered orally once daily

Trial Locations (38)

10016

New York University Hepatology Associates, New York

19141

Einstein Medical Center, Philadelphia

21202

Mercy Medical Center - Mcauley Plaza, Baltimore

22908

UVA Health - University of Virginia Health System, Charlottesville

23502

Gastrointestinal and Liver Specialists of Tidewater - Digestive and Liver Disease Specialists, Norfolk

27157

Wake Forest University Baptist Medical Center, Winston-Salem

32610

University of Florida Hepatology Research at CTRB, Gainesville

33136

University of Miami Leonard M. Miller School of Medicine, Miami

34211

Florida Research Institute, Lakewood Rch

37232

Vanderbilt Digestive Disease Center, Nashville

45267

University of Cincinnati, Cincinnati

57701

Rapid City Medical Center, Rapid City

62702

Springfield Clinic, Springfield

68124

CommonSpirit Health Research Institute, Omaha

77099

Pioneer Research Solutions, Houston

80921

Peak Gastroenterology Associates Colorado Springs, Colorado Springs

85724

UA Thomas D. Boyer Liver Institute, Tucson

90048

Cedars-Sinai Medical Center, Los Angeles

92118

Southern California Research Center - Coronado, Coronado

92704

Velocity Clinical Research, Santa Ana

98105

Liver Institute Northwest, Seattle

V6Z 2K5

(G.I,R,I) GI Research Institute, Vancouver

P1B 2H3

Office of Dr. Gauthier, North Bay

M5G 2C4

Toronto General Hospital, Toronto

H2X 0A9

Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), Montreal

Unknown

306, Fukui

313, Fukuoka

305, Hamamatsu

308, Hirakata

309, Hiroshima

304, Isehara

303, Itabashi-ku

312, Kanazawa

307, Matsumoto

311, Ōmura

302, Sapporo

Teine Keijinkai Hospital, Sapporo

314, Yokohama

Sponsors
All Listed Sponsors
lead

Kowa Research Institute, Inc.

INDUSTRY