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

NCT06975150 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: HK-660S-202
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

HK-660S-202; PSC; Primary Sclerosing Cholangitis; HK-660S

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects who show improvement of ALP

  The improvement of ALP is defined as 20% or more ALP reduction

  12 weeks from baseline

Secondary Outcomes (12)

• Percentage of subjects who show improvement of severity of PSC

  12 weeks from baseline

• Percentage of subjects who show improvement of bile duct strictures in MRCP

  12 weeks from baseline

• Percentage of subjects who show 50% or more reduction of ALP

  12 weeks from baseline

• Percentage of subjects who show ALP normalization or partial normalization (< 1.5 x ULN)

  12 weeks from baseline

• Percentage of subjects who show improvement of severity of fibrosis in FibroScan

  12 weeks from baseline

Study Arms (3)

HK-660S 100mg

EXPERIMENTAL

oral administration of 100 mg HK-660S (one active tablet and one placebo tablet) twice a day on an empty stomach in the morning and evening

Drug: HK-660S 100mg

HK-660S 200mg

EXPERIMENTAL

oral administration of 200 mg HK-660S (two active tablets) twice a day on an empty stomach in the morning and evening

Drug: HK-660S 200mg

Placebo

PLACEBO COMPARATOR

oral administration of two placebo tablets twice a day on an empty stomach in the morning and evening

Drug: Placebo

Interventions

HK-660S 100mg DRUG

Administered orally

HK-660S 100mg

HK-660S 200mg DRUG

Administered orally

HK-660S 200mg

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female subjects aged ≥ 18 years.
• Subjects and their sexual partner(s) who do not plan to become pregnant and agree to use at least one effective, appropriate contraceptive method (defined below) during the study period and up to 30 days after the last dosing of study drug
• Contraception method: 1) hormonal contraceptives, 2) intrauterine contraceptive device or implantation of intrauterine system, 3) double-barrier method (combined use of spermicides and condoms, diaphragm, contraceptive sponge, or FemCap), or 4) sterilization (e.g., vasectomy, tubal ligation)
• Women who are post-menopausal (have amenorrhea for 12 months or over 6 weeks after bilateral oophorectomy) and unlikely to become pregnant
• Subjects who have a diagnosis of PSC:
• Serum alkaline phosphatase (ALP) of \> 2.0 x upper limit of normal (ULN) at screening
• Subjects who have sclerosing cholangitis due to multifocal bile duct in magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP) within 6 months from screening
• Subjects who are able to understand information provided directly or via his/her representative and to 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: non-alcoholic fatty liver disease, viral chronic hepatitis, alcoholic liver disease, primary biliary liver cholangitis, biliary obstruction, autoimmune hepatitis, hemoglobin deposition, Wilson's disease, α-1 antitrypsin deficiency, etc.
• Subjects who have a diagnosis of primary biliary cholangitis or secondary sclerosing cholangitis in MRCP or ERCP prior to screening.
• Subjects who have obstacles to MRCP implementation (e.g., cardiac pacemakers, clipped cerebral aneurysms, metallic foreign objects in the eyeball, claustrophobia).
• Subjects who have ALT or AST \> 5 x ULN.
• Subjects who have serum creatinine ≥ 2 mg/dl.
• 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 uncontrolled thyroid diseases including hyperthyroidism and hypothyroidism. However, subjects who have been stably managed with thyroid disease treatment for at least 6 months prior to Screening may be included at the discretion of the investigator.
• Subjects who have a history of immune diseases: autoimmune thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatoid arthritis, etc. However, at the discretion of the investigator, patients with atopic dermatitis that is mild or can be stably managed with topical atopic dermatitis treatment may be included.
• Subjects who had bariatric surgery within 6 months prior to screening.
• Subjects who have undergone or are planned for liver transplantation or with current model of end stage liver disease (MELD).
• Subjects who have positive results at the Screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
• Subjects who have a history of chronic infections or have severe or life-threatening infections, or symptoms that may be considered related to infections (e.g., fever, cough). However, subjects with mild-to-moderate inflammatory bowel diseases (e.g., ulcerative colitis, Crohn's disease) who can be stably managed with 5-aminosalicylic acid, azathioprine or topical steroids may be included at the discretion of the investigator. Subjects on biologics (e.g. infliximab, adalimumab, vedolizumab, ustekinumab) or JAK inhibitors (e.g. tofacitinib) for IBD treatment are allowed if the dose has been stable for at least 12 weeks before Screening and is expected to remain stable throughout the study.

Sponsors & Collaborators

• CuromeBiosciences: lead

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: May 16, 2025

Record last verified: 2025-05