Clinical Trial

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

Not Yet Recruiting Phase 2
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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.
Trial Details
NCT Number NCT06975150
Lead Sponsor CuromeBiosciences
Conditions Primary Sclerosing Cholangitis (PSC)
Enrollment 105 participants
Start Date 2025-08-18
Primary Completion 2028-08-30 (estimated)
Study Completion 2028-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-16