Primary Sclerosing Cholangitis (PSC)Phase 2NCT06975150
Efficacy and Safety of HK-660S in the Treatment of Primary Sclerosing Cholangitis
A Phase 2 study testing HK-660S 100mg and HK-660S 200mg in people with Primary Sclerosing Cholangitis (PSC), run by CuromeBiosciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sclerosing Cholangitis (PSC)
- What is being tested?
- HK-660S 100mg and HK-660S 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 18 Aug 2025to 30 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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.
- Subjects with evidence of an active infection during the screening period.
- Subjects diagnosed with a malignant tumor without complete cure within 5 years prior to screening.
- Subjects whose medication history includes any of the following drugs, within a period of 5 times the half-life of the respective drug prior to screening:
- Therapeutics agents for steatohepatitis: thiazolidinediones, high-dose vitamin E (800 IU/day), pentoxifylline
- Medications possibly related to PSC: high-dose ursodeoxycholic acid (UDCA; doses smaller than 28 mg/kg/day may be permitted if administered stably without change in dosage from 3 months prior to screening), immunosuppressants, obeticholic acid (OCA), budesonide, docosahexaenoic acid, methotrexate, metronidazole, minocycline, mycophenolate mofetil, nicotine, pentoxifylline, pirfenidone, prednisolone, systemic glucocorticoids, tacrolimus (If a patient is on any of the following medications and/or supplements, he or she can participate only expected to remain on the same daily dose through the treatment period: UDCA, vancomycin, azathioprine, prednisone [or an equivalent steroid compound]).
- Subjects who administered herbal medicine or folk remedies to improve fatty liver disease within 2 weeks prior screening.
- Subjects who have a history of alcohol or drug abuse within 5 years prior to screening.
- Subjects who have a hypersensitivity to any excipients of the study drug.
- Subjects who participated in another drug trial within 30 days prior to screening.
- Subjects who are considered inappropriate to participate in clinical trials at the discretion of the investigator.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group, 12 Weeks, Phase 2b Clinical Study to Evaluate the Efficacy and Safety of HK-660S in Patients With Primary Sclerosing Cholangitis (PSC)
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.
Read the detailed description
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.
After subjects voluntarily consent in writing to participate in the clinical study, subjects who meet the inclusion/exclusion criteria will be evaluated through a screening period. The screening period should not, as far as possible, exceed a maximum of 5 weeks including the washout period. Based on the screening results at Visit 1, subjects suitable for participation in this clinical study will be selected.
In Part A, 6 subjects will be assigned to 200 mg HK-660S twice a day for 12 weeks. After Visit 2, subjects will visit the study center at Week 4 (Visit 3), Week 8 (Visit 4), Week 12 (Visit 5 / End of Treatment), and Week 16 (Visit 6 / Follow-up) to assess the efficacy and safety (excluding MRCP at Visit 6). Enrollment will be staggered, with the first two subjects enrolled and monitored for the initial 4-week treatment period. Interim safety data from these initial two subjects will be reviewed by the Sponsor and medical monitor to assess any significant safety concerns. If no such concerns are identified, enrollment of the remaining four subjects will proceed. Safety data from the first 4-week treatment in all 6 subjects will be reviewed by the SRC, which will decide on the initiation of Part B.
In Part B, 99 subjects will be randomly assigned in a 1:1:1 ratio into one of three groups: 100 mg HK-660S, 200 mg HK-660S, or placebo to take two tablets (1 active and 1 placebo tablets, 2 active tablets, or 2 placebo tablets) twice a day for 12 weeks. After Visit 2, subjects will visit the study center at Week 4 (Visit 3), Week 8 (Visit 4), Week 12 (Visit 5 / End of Treatment), and Week 16 (Visit 6 / Follow-up) to assess the efficacy and safety (excluding MRCP at Visit 6).
The study period for each subject is approximately 21 weeks including up to 5-week screening period, 12-week treatment period, and 4-week follow-up period.
- Conditions
- Primary Sclerosing Cholangitis (PSC)
- Being tested
- HK-660S 100mg, HK-660S 200mg, Placebo
- Keywords
- HK-660S-202, PSC, Primary Sclerosing Cholangitis, HK-660S
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HK-660S 100mgDrug
Administered orally
HK-660S 200mgDrug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who show improvement of ALP
The improvement of ALP is defined as 20% or more ALP reduction
Measured: 12 weeks from baseline
Secondary outcomes (12)
Percentage of subjects who show improvement of severity of PSC
The improvement of severity is defined as a decrease of -1 or more in the MRCP Anali score
Measured: 12 weeks from baseline
Percentage of subjects who show improvement of bile duct strictures in MRCP
Defined as improvement (absence or improvement) in at least one of bile strictures, dilatation or bile ductal wall thickening and enhancement based on the IPSCSG (International Primary Sclerosing Cholangitis Study Group) MRI Reporting Guideline.
Measured: 12 weeks from baseline
Percentage of subjects who show 50% or more reduction of ALP
Measured: 12 weeks from baseline
Percentage of subjects who show ALP normalization or partial normalization (< 1.5 x ULN)
Measured: 12 weeks from baseline
Percentage of subjects who show improvement of severity of fibrosis in FibroScan
Measured: 12 weeks from baseline
Change of fibrosis score in FibroScan
Measured: 12 weeks from baseline
Percentage of subjects who show improvement of severity of liver fibrosis in Enhanced Liver Fibrosis (ELF) score
Measured: 12 weeks from baseline
Change of ELF score
Measured: 12 weeks from baseline
Change of pruritus score
Measured: 4, 8, and 12 weeks from baseline
Change of serum C4 (7α-hydroxy-4-cholesten-3-one) level
Measured: 12 weeks from baseline
Change of ALP level
Measured: 4, 8, and 12 weeks from baseline
Change of ALT, AST, GGT, and bilirubin levels
Measured: 4, 8, and 12 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start18 Aug 2025 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing Cholangitis (PSC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CuromeBiosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975150
- Sponsor's protocol ID
- HK-660S-202
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel Group, 12 Weeks, Phase 2b Clinical Study to Evaluate the Efficacy and Safety of HK-660S in Patients With Primary Sclerosing Cholangitis (PSC)
- ClinicalTrials.gov ID
- NCT06975150
- Acronym / sponsor ID
- HK-660S-202
- Conditions
- Primary Sclerosing Cholangitis (PSC)
- Keywords
- HK-660S-202, PSC, Primary Sclerosing Cholangitis, HK-660S
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- CuromeBiosciencesIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2025 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
After subjects voluntarily consent in writing to participate in the clinical study, subjects who meet the inclusion/exclusion criteria will be evaluated through a screening period. The screening period should not, as far as possible, exceed a maximum of 5 weeks including the washout period. Based on the screening results at Visit 1, subjects suitable for participation in this clinical study will be selected.
In Part A, 6 subjects will be assigned to 200 mg HK-660S twice a day for 12 weeks. After Visit 2, subjects will visit the study center at Week 4 (Visit 3), Week 8 (Visit 4), Week 12 (Visit 5 / End of Treatment), and Week 16 (Visit 6 / Follow-up) to assess the efficacy and safety (excluding MRCP at Visit 6). Enrollment will be staggered, with the first two subjects enrolled and monitored for the initial 4-week treatment period. Interim safety data from these initial two subjects will be reviewed by the Sponsor and medical monitor to assess any significant safety concerns. If no such concerns are identified, enrollment of the remaining four subjects will proceed. Safety data from the first 4-week treatment in all 6 subjects will be reviewed by the SRC, which will decide on the initiation of Part B.
In Part B, 99 subjects will be randomly assigned in a 1:1:1 ratio into one of three groups: 100 mg HK-660S, 200 mg HK-660S, or placebo to take two tablets (1 active and 1 placebo tablets, 2 active tablets, or 2 placebo tablets) twice a day for 12 weeks. After Visit 2, subjects will visit the study center at Week 4 (Visit 3), Week 8 (Visit 4), Week 12 (Visit 5 / End of Treatment), and Week 16 (Visit 6 / Follow-up) to assess the efficacy and safety (excluding MRCP at Visit 6).
The study period for each subject is approximately 21 weeks including up to 5-week screening period, 12-week treatment period, and 4-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HK-660S 100mg | Experimental | Drug: HK-660S 100mgoral 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 |
| HK-660S 200mg | Experimental | Drug: HK-660S 200mgoral administration of 200 mg HK-660S (two active tablets) twice a day on an empty stomach in the morning and evening |
| Placebo | Placebo comparator | Drug: Placebooral administration of two placebo tablets twice a day on an empty stomach in the morning and evening |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects aged ≥ 18 years.
- Subjects who have a diagnosis of PSC:
- 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.
Key exclusion criteria (25 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HK-660S 100mgAdministered orally | Drug | HK-660S 100mg |
| HK-660S 200mgAdministered orally | Drug | HK-660S 200mg |
| PlaceboAdministered orally | Drug | Placebo |
Primary outcome
Percentage of subjects who show improvement of ALP
Time frame: 12 weeks from baseline
The improvement of ALP is defined as 20% or more ALP reduction
12 secondary outcomes
Percentage of subjects who show improvement of severity of PSC
Time frame: 12 weeks from baseline
Percentage of subjects who show improvement of bile duct strictures in MRCP
Time frame: 12 weeks from baseline
Percentage of subjects who show 50% or more reduction of ALP
Time frame: 12 weeks from baseline
Percentage of subjects who show ALP normalization or partial normalization (< 1.5 x ULN)
Time frame: 12 weeks from baseline
Percentage of subjects who show improvement of severity of fibrosis in FibroScan
Time frame: 12 weeks from baseline
Change of fibrosis score in FibroScan
Time frame: 12 weeks from baseline
Percentage of subjects who show improvement of severity of liver fibrosis in Enhanced Liver Fibrosis (ELF) score
Time frame: 12 weeks from baseline
Change of ELF score
Time frame: 12 weeks from baseline
Change of pruritus score
Time frame: 4, 8, and 12 weeks from baseline
Change of serum C4 (7α-hydroxy-4-cholesten-3-one) level
Time frame: 12 weeks from baseline
Change of ALP level
Time frame: 4, 8, and 12 weeks from baseline
Change of ALT, AST, GGT, and bilirubin levels
Time frame: 4, 8, and 12 weeks from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Primary Sclerosing Cholangitis (PSC)
RecruitingObservational study
Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach
Primary Sclerosing Cholangitis
Not yet recruitingPhase 2
FEAST and HOPE: Redox PSC Pilot Study
Primary Sclerosing Cholangitis (PSC)
RecruitingPhase 3
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis
Active, not recruitingPhase 2
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
Primary Sclerosing Cholangitis
Active, not recruitingPhase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HK-660S 100mg and HK-660S 200mg in people with Primary Sclerosing Cholangitis (PSC), run by CuromeBiosciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who show improvement of ALP (time frame: 12 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.