Efficacy and Safety of HK-660S in the Treatment of Primary Sclerosing Cholangitis
Status:
NOT_YET_RECRUITING
Trial end date:
2028-08-30
Target enrollment:
Participant gender:
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.