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
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
UA Thomas D. Boyer Liver Institute
Tucson
California
Southern California Research Center - Coronado
Coronado
Cedars-Sinai Medical Center
Los Angeles
Velocity Clinical Research
Santa Ana
Colorado
Peak Gastroenterology Associates Colorado Springs
Colorado Springs
Florida
University of Florida Hepatology Research at CTRB
Gainesville
Florida Research Institute
Lakewood Rch
University of Miami Leonard M. Miller School of Medicine
Miami
Illinois
Springfield Clinic
Springfield
Maryland
Mercy Medical Center - Mcauley Plaza
Baltimore
North Carolina
Wake Forest University Baptist Medical Center
Winston-salem
Nebraska
CommonSpirit Health Research Institute
Omaha
New York
New York University Hepatology Associates
New York
Ohio
University of Cincinnati
Cincinnati
Pennsylvania
Einstein Medical Center
Philadelphia
South Dakota
Rapid City Medical Center
Rapid City
Tennessee
Vanderbilt Digestive Disease Center
Nashville
Texas
Pioneer Research Solutions
Houston
Virginia
UVA Health - University of Virginia Health System
Charlottesville
Gastrointestinal and Liver Specialists of Tidewater - Digestive and Liver Disease Specialists
Norfolk
Washington
Liver Institute Northwest
Seattle
Other Locations
Canada
Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
Montreal
Office of Dr. Gauthier
North Bay
Toronto General Hospital
Toronto
(G.I,R,I) GI Research Institute
Vancouver
Japan
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
Time Frame
Start Date: 2024-02-07
Completion Date: 2026-06
Participants
Target number of participants: 46
Treatments
Placebo_comparator: Placebo + K-877 (Group A)
Placebo for 12 Weeks followed by K-808 (Dose A) for 52 Weeks
Placebo_comparator: Placebo + K-877 (Group B)
Placebo for 12 Weeks followed by K-808 (Dose B) for 52 Weeks
Experimental: K-808 Group A
K-808 (Dose A) for 64 Weeks
Experimental: K-808 Group B
K-808 (Dose B) for 64 Weeks
Related Therapeutic Areas
Sponsors
Leads: Kowa Research Institute, Inc.