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

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

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 Overview

• Status: Terminated
• Conditions: Primary Sclerosing Cholangitis
• Intervention / Treatment: Drug: DUR-928

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • California Pacific Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Southern Therapy and Advanced Research
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Charlotte Mecklenburg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DUR-928 10 mg; 10 mg oral suspension	Drug: DUR-928; oral suspension daily for 28 days
Experimental: DUR-928 50 mg; 50 mg oral suspension	Drug: DUR-928; oral suspension daily for 28 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change of Liver Enzymes and Serum Bile Acids (sBA)	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).	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

Collaborators and Investigators

• Sponsor: Durect
• Investigators: Study Director: Alastair Smith, MD, INC Research/InVentiv Health

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: September 20, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholangitis; Cholangitis, Sclerosing
• Other Study ID Numbers: C928-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No