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

NCT06247735 Phase 2 ACTIVE_NOT_RECRUITING

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

Details

Lead sponsor	Kowa Research Institute, Inc.
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	46
Start date	2024-02-07
Completion	2026-06

Conditions

• Primary Biliary Cholangitis

Interventions

• K-808 (Dose A)
• K-808 (Dose B)
• Placebo

Primary outcomes

• Percent change from baseline in serum alkaline phosphatase (ALP) — Baseline to Week 12
  Two doses of K-808 compared to placebo after 12 weeks of treatment

Countries

United States, Canada, Japan