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

NCT06975150 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2025-05-16

No results posted yet for this study

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.

Conditions

  • Primary Sclerosing Cholangitis (PSC)

Interventions

DRUG

HK-660S 100mg

Administered orally

DRUG

HK-660S 200mg

Administered orally

DRUG

Placebo

Administered orally

Sponsors & Collaborators

  • CuromeBiosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2028-08-30
Completion
2028-08-30
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06975150 on ClinicalTrials.gov