Efficacy and Safety of HK-660S in the Treatment of Primary Sclerosing Cholangitis

Summary

The cause of PSC is unknown.To date, there is no treatment besides liver transplantation proven to improve PSC prognosis. However, there is a clear medical unmet need yet for patients with PSC, due to risks and complications of liver transplantation. This is a two-part, Phase 2b, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of HK-660S in patients with PSC. The primary objective is to evaluate the effects of HK-660S on serum ALP improvement (reduction of 20% or more) over 12 weeks of treatment in patients with PSC.

Timeline

Start

2025-08-18

Primary completion

2028-08-30

Completion

2028-08-30

Drugs

Indications