A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)

Phase 2

Terminated

Brief Summary: This is a research trial testing DUR-928 (an experimental medication). The purpose of the trial is to assess whether treatment with DUR-928 has any effect on the treatment of Primary Sclerosing Cholangitis (PSC). This trial will also assess safety (side effects).

Recruitment & Eligibility

Inclusion Criteria

Verified diagnosis of primary sclerosing cholangitis (PSC) for at least 12 months, with or without inflammatory bowel disease (IBD).
Serum alkaline phosphatase (ALP) ≥ 1.5 times ULN and with no >15% fluctuation in the past 3 months.
In subjects receiving treatment with ursodeoxycholic acid (UDCA), therapy must be stable for at least 3 months and at a dose not greater than 20 mg/kg/day.
Subjects of childbearing potential must agree to use a medically acceptable method of contraceptive to prevent pregnancy in the subject and/or the partner for the duration of their participation in the trial up to 2 months after the last study drug dosing.

Exclusion Criteria

Presence of documented secondary sclerosing cholangitis or small duct PSC
Bacterial cholangitis within 30 days prior to Screening
Presence of percutaneous drain or endoscopic bile duct stent
History of, or suspicion of cholangiocarcinoma.
Prior liver transplantation, or currently listed for liver transplantation
Presence of other concomitant liver diseases
Moderate to Severe active IBD or flare in colitis activity within the last 3 months
Any severe and/or untreated concomitant cardiovascular, renal, endocrine or psychiatric disorder
Any active malignant disease (within 3 years), other than non-melanomatous skin cancer
Human immunodeficiency virus (HIV) infection
Existing or intended pregnancy, or breast feeding
Has received medication from another clinical trial within the past 30 days

Arm && Interventions

Group	Intervention	Description
DUR-928 10 mg	DUR-928	10 mg oral suspension
DUR-928 50 mg	DUR-928	50 mg oral suspension

Primary Outcome Measures

Name	Time	Method
Percent Change of Alkaline Phosphatase (ALP) From Baseline	Day 28 (end of treatment) and Day 56 (end of study/early termination)

Secondary Outcome Measures

Name	Time	Method
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)	Day 28 and Day 56	Liver enzymes include alanine transaminase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), bilirubin. Percent change from baseline through the end of study treatment (Day 28) and throughout the follow-up period (Day 56).
Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline	Day 28 (end of treatment) and Day 56 (end of follow-up)
Percent Change of Selected Biomarkers From Baseline Through the End of Study Treatment and Throughout the Follow-up Period.	Day 28 and Day 56

Locations (4): Charlotte Mecklenburg Hospital
🇺🇸
Charlotte, North Carolina, United States
California Pacific Medical Center
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San Francisco, California, United States
Southern Therapy and Advanced Research
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Jackson, Mississippi, United States
Mayo Clinic Florida
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Jacksonville, Florida, United States