Evaluation of the Safety and Efficacy of HK-660S in Patients With Primary Sclerosing Cholangitis

NCT05866809 | Completed Phase 2

• 1 other identifier: HK-660S-201
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

Brief Summary

The objective of this study is to evaluate the improvement of bile duct strictures following the administration of HK-660S in patients with Primary Sclerosing Cholangitis(PSC). Percentage of subjects who show improvement of severity of PSC as assessed by Magnetic Resonance Cholangiopancreatography(MRCP) at Week 12 from baseline, with improvement defined as a decrease of -1 or more in the MRCP and change of alkaline phosphatase(ALP) level will be assessed at Week 12 from baseline.

Conditions

Primary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (2)

• MRCP

  Percentage of subjects who show improvement of severity of PSC as assessed by MRCP with improvement defined as a decrease of -1 or more in the MRCP score

  Week 12 from baseline

• ALP

  Change of ALP level

  Week 12 from baseline

Study Arms (2)

HK-660S

EXPERIMENTAL

Oral administration of HK-660S 100 mg (1 tablet) twice daily before morning and evening meals

Drug: HK-660S

Placebo

PLACEBO COMPARATOR

Oral administration of placebo 1 tablet twice daily before morning and evening meals

Drug: Placebo

Interventions

HK-660S DRUG

Administered orally

HK-660S

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged ≥ 17 years
• Subjects who have a diagnosis of PSC
• Subjects who are able to understand the information provided directly or via his/her representative and give voluntary, written consent to participate in the study.

You may not qualify if:

• Subjects with an average alcohol intake of more than 20g per day within 2 years prior to screening.
• Subjects who have a diagnosis of type 1 diabetes or uncontrolled type 2 diabetes (HbA1c ≥ 9%) prior to screening.
• Subjects who have chronic liver diseases other than PSC
• Subjects who have a diagnosis of primary biliary cirrhosis or secondary sclerosing cholangitis in MRCP or Endoscopic Retrograde Cholangiopancreatography(ERCP) prior to screening.
• Subjects who have obstacles to MRCP implementation
• Subjects who have a positive result of hepatitis B surface antigen (HBsAg test) and/or hepatitis C antibody (HCV-Ab test)
• Subjects who have Alanine Aminotransferase(ALT) or Aspartate aminotransferase(AST) \> 10 x upper limit of normal(ULN)
• Subjects who have serum creatinine ≥ 2 mg/dl
• Subjects who have weight changes of 5 kg or more within 6 months prior to screening
• Subjects who are deemed unsuitable for participation in the study at Screening, at the discretion of the investigator, due to the following: cirrhosis, severe metabolic disease, severe renal failure, severe lung disease, severe neuro/psychiatric disease, muscle disease, etc.
• Subjects who have any clinically significant cardiovascular diseases
• Subjects who have thyroid diseases including hyperthyroidism and hypothyroidism
• Subjects who have a history of immune diseases
• Subjects who had bariatric surgery within 6 months prior to screening
• Subjects who had liver transplant surgery

Sponsors & Collaborators

• CuromeBiosciences: lead

Study Sites (4)

Seoul National University Hospital

Seoul, 02080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

ASAN Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Do-hyun Park

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 19, 2023
• Study Start: October 28, 2021
• Primary Completion: June 23, 2023
• Study Completion: July 24, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-05

Locations

KR (4)