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

Overview

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).

Full Title of Study: “A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 31, 2019

Interventions

  • Drug: DUR-928
    • oral suspension daily for 28 days

Arms, Groups and Cohorts

  • Experimental: DUR-928 10 mg
    • 10 mg oral suspension
  • Experimental: DUR-928 50 mg
    • 50 mg oral suspension

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
    • Time Frame: 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
    • Time Frame: 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.
    • Time Frame: Day 28 and Day 56

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Durect
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alastair Smith, MD, Study Director, INC Research/InVentiv Health

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