NCT03394781TerminatedPhase 2
A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Durect
- Enrollment
- 5
- Locations
- 4
- Primary Endpoint
- Percent Change of Alkaline Phosphatase (ALP) From Baseline
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
DUR-928 10 mg
Experimental
10 mg oral suspension
Intervention: DUR-928 (Drug)
DUR-928 50 mg
Experimental
50 mg oral suspension
Intervention: DUR-928 (Drug)
Outcomes
Primary Outcomes
Percent Change of Alkaline Phosphatase (ALP) From Baseline
Time Frame: Day 28 (end of treatment) and Day 56 (end of study/early termination)
Secondary Outcomes
- Percent Change of Liver Enzymes and Serum Bile Acids (sBA)(Day 28 and 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)
Investigators
Study Sites (4)
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