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

Primary Purpose

Primary Sclerosing Cholangitis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

DUR-928

About this trial

This is an interventional treatment trial for Primary Sclerosing Cholangitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

California Pacific Medical Center
Mayo Clinic Florida
Southern Therapy and Advanced Research
Charlotte Mecklenburg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

DUR-928 10 mg

DUR-928 50 mg

Arm Description

10 mg oral suspension

50 mg oral suspension

Outcomes

Primary Outcome Measures

Percent Change of Alkaline Phosphatase (ALP) From Baseline

Secondary Outcome Measures

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).

Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline

Percent Change of Selected Biomarkers From Baseline Through the End of Study Treatment and Throughout the Follow-up Period.

Full Information

NCT ID

NCT03394781

First Posted

January 3, 2018

Last Updated

September 20, 2022

Sponsor

Durect

1. Study Identification

Unique Protocol Identification Number

NCT03394781

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Why Stopped

poor enrollment

Study Start Date

January 22, 2018 (Actual)

Primary Completion Date

January 31, 2019 (Actual)

Study Completion Date

January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Durect

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Sclerosing Cholangitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DUR-928 10 mg

Arm Type

Experimental

Arm Description

10 mg oral suspension

Arm Title

DUR-928 50 mg

Arm Type

Experimental

Arm Description

50 mg oral suspension

Intervention Type

Drug

Intervention Name(s)

DUR-928

Intervention Description

oral suspension daily for 28 days

Primary Outcome Measure Information:

Title

Percent Change of Alkaline Phosphatase (ALP) From Baseline

Time Frame

Day 28 (end of treatment) and Day 56 (end of study/early termination)

Secondary Outcome Measure Information:

Title

Percent Change of Liver Enzymes and Serum Bile Acids (sBA)

Description

Time Frame

Day 28 and Day 56

Title

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)

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alastair Smith, MD

Organizational Affiliation

INC Research/InVentiv Health

Official's Role

Study Director

Facility Information:

Facility Name

California Pacific Medical Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Mayo Clinic Florida

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Southern Therapy and Advanced Research

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Charlotte Mecklenburg Hospital

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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