NCT03394781

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

Terminated Phase 2 Results posted Last updated 17 October 2022

What this trial tests

Phase 2 trial testing DUR-928 in Primary Sclerosing Cholangitis in 5 participants. Terminated before completion.

Timeline

22 January 2018

Primary endpoint
31 January 2019

31 January 2019

Quick facts

Lead sponsor	Durect
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	22 January 2018
Primary completion	31 January 2019
Estimated completion	31 January 2019
Sites	4 locations across United States

Drugs / interventions tested

• DUR-928 — full drug profile →

Conditions studied

• Primary Sclerosing Cholangitis — all drugs for Primary Sclerosing Cholangitis →

Sponsor

Durect — full company profile →

Who can join

Adults 18 to 80, any sex, with Primary Sclerosing Cholangitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Percent change of ALP from baseline to Day 28

Group	Value	95% CI
DUR-928 10 mg	23.7	± 10.7
DUR-928 50 mg	16.8	± 2.97

Percent change of ALP from baseline to Day 56

Group	Value	95% CI
DUR-928 10 mg	10.7	± 17.04
DUR-928 50 mg	11.05	± 8.68

Percent Change of Liver Enzymes and Serum Bile Acids (sBA) Secondary · 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 ALT change from baseline to Day 28

Group	Value	95% CI
DUR-928 10 mg	32.87	± 48.87
DUR-928 50 mg	3.0	± 29.56

percent AST change from baseline to Day 28

Group	Value	95% CI
DUR-928 10 mg	24.10	± 35.03
DUR-928 50 mg	-20.25	± 3.23

percent GGT change from baseline to Day 28

Group	Value	95% CI
DUR-928 10 mg	7.3	± 4.16
DUR-928 50 mg	8.15	± 1.49

percent direct bilirubin change from baseline to Day 28

Group	Value	95% CI
DUR-928 10 mg	14.2	± 24.61
DUR-928 50 mg	34.6	± NA

percent total bilirubin change from baseline to Day 28

Group	Value	95% CI
DUR-928 10 mg	12.03	± 23.09
DUR-928 50 mg	23.85	± 33.73

percent serum bile acids change from baseline to Day 28

Group	Value	95% CI
DUR-928 10 mg	-13.93	± 15.00
DUR-928 50 mg	-44.10	± 46.95

percent ALT change from baseline to Day 56

Group	Value	95% CI
DUR-928 10 mg	-9.77	± 15.30
DUR-928 50 mg	-12.7	± 5.66

percent AST change from baseline to Day 56

Group	Value	95% CI
DUR-928 10 mg	-16.23	± 9.17
DUR-928 50 mg	-9.70	± 19.09

Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline Secondary · Day 28 (end of treatment) and Day 56 (end of follow-up)

subjects with ≥ 40% reduction of serum ALP from baseline at day 28/end of treatment

Group	Value	95% CI
DUR-928 10 mg	0
DUR-928 50 mg	0

subjects with ≥ 40% reduction of serum ALP from baseline at day 56/end of follow-up

Group	Value	95% CI
DUR-928 10 mg	0
DUR-928 50 mg	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 56 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DUR-928 10 mg

Serious: 0/3 (0%)

Deaths: 0/3

DUR-928 50 mg

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (9 terms — click to expand)

Reaction	System	DUR-928 10 mg	DUR-928 50 mg
DRUG INDUCED LIVER INJURY	Hepatobiliary disorders	—	—
WORSENING SINUS BRADYCARDIA	Cardiac disorders	—	—
EXCESSIVE GAS (FLATUS)	Gastrointestinal disorders	—	—
ELEVATED ALKALINE PHOSPHATASE	Investigations	—	—
ELEVATED ALT	Investigations	—	—
ELEVATED AST	Investigations	—	—
ELEVATED GGT	Investigations	—	—
ELEVATED SERUM BILE ACIDS	Investigations	—	—
LEFT EAR ERYTHEMA PRESENT	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT03394781 adverse events section.

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Management of Cholestatic Liver Diseases: Current Therapies and Emerging New Possibilities.
   Mazzetti M, Marconi G, Mancinelli M, Benedetti A, et al · · 2021 · cited 17× · PMID 33919600 · DOI 10.3390/jcm10081763
2. An overview of recent treatment options for primary sclerosing cholangitis.
   Mousavere I, Kalampokis G, Fousekis F, Karayiannis P, et al · · 2023 · cited 8× · PMID 38023975 · DOI 10.20524/aog.2023.0834
3. Safety and efficacy of HK-660S in patients with primary sclerosing cholangitis: A randomized double-blind phase 2a trial.
   Paik WH, Park JK, Chung MJ, Huh G, et al · · 2025 · cited 6× · PMID 39314133 · DOI 10.3350/cmh.2024.0629
4. Novel Therapies for Managing Cholestasis.
   Santiago P, Levy C. · · 2020 · cited 3× · PMID 32257119 · DOI 10.1002/cld.886