Primary Sclerosing CholangitisPhase 2NCT03394781

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

A Phase 2 study testing DUR-928 in people with Primary Sclerosing Cholangitis, run by Durect at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Primary Sclerosing Cholangitis
What is being tested?: DUR-928
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 4 sitesUnited States
Study dates: 22 Jan 2018to 31 Jan 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

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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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

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

Other trials in United States

About this study

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

Conditions: Primary Sclerosing Cholangitis
Being tested: DUR-928
Medical subject headings: Cholangitis, Sclerosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DUR-928Drug
oral suspension daily for 28 days

Study groups in NCT03394781
Study group	Role	What they receive
DUR-928 10 mg	Experimental	10 mg oral suspension Receives: Drug: DUR-928
DUR-928 50 mg	Experimental	50 mg oral suspension Receives: Drug: DUR-928

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

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).
Measured: Day 28 and Day 56
Percent of Subjects With Reduction of Serum Alkaline Phosphatase (ALP) From Baseline
Measured: 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.
Measured: Day 28 and Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 201831 Jan 2019

First posted9 Jan 2018
Study start22 Jan 2018
Primary completion31 Jan 2019
Study completion31 Jan 2019

Why it stopped: poor enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03394781
Sponsor's protocol ID: C928-008
Status last verified: Aug 2022
First submitted: 3 Jan 2018
Last updated: 17 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach
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Not yet recruitingPhase 2
FEAST and HOPE: Redox PSC Pilot Study
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RecruitingPhase 3
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis
Active, not recruitingPhase 2
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
Primary Sclerosing Cholangitis
Active, not recruitingPhase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis

All Primary Sclerosing Cholangitis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Phase 2 Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC)
ClinicalTrials.gov ID: NCT03394781
Acronym / sponsor ID: C928-008
Conditions: Primary Sclerosing Cholangitis
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: poor enrollment
Enrolment: 5 participants (actual)
Lead sponsor: DurectIndustry (pharma, biotech, devices)
Study start: 22 Jan 2018 (actual)
Primary completion: 31 Jan 2019 (actual)
Study completion: 31 Jan 2019 (actual)
First posted: 9 Jan 2018 (actual)
Results: Posted 17 Oct 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DUR-928 10 mg	Experimental	Drug: DUR-92810 mg oral suspension
DUR-928 50 mg	Experimental	Drug: DUR-92850 mg oral suspension

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DUR-928oral suspension daily for 28 days	Drug	DUR-928 10 mg, DUR-928 50 mg

Primary outcome

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

3 secondary outcomes

Percent Change of Liver Enzymes and Serum Bile Acids (sBA)
Time frame: Day 28 and 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

Results and safety

Results posted to the registry on 17 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DUR-928 10 mg	3	3
DUR-928 50 mg	2	2

Primary outcome: Percent Change of Alkaline Phosphatase (ALP) From Baseline

Time frame: Day 28 (end of treatment) and Day 56 (end of study/early termination). Mean (Standard Deviation). Unit: percent change

Measure	DUR-928 10 mg n = 3	DUR-928 50 mg n = 2
Percent change of ALP from baseline to Day 28	23.7 (10.7)	16.8 (2.97)
Percent change of ALP from baseline to Day 56	10.7 (17.04)	11.05 (8.68)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 56 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DUR-928 10 mg	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
DUR-928 50 mg	0 of 2 (0%)	1 of 2 (50%)	0 of 2

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Primary Sclerosing Cholangitis

RecruitingObservational study
Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach
Primary Sclerosing Cholangitis
Not yet recruitingPhase 2
FEAST and HOPE: Redox PSC Pilot Study
Primary Sclerosing Cholangitis (PSC)
RecruitingPhase 3
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis
Active, not recruitingPhase 2
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
Primary Sclerosing Cholangitis
Active, not recruitingPhase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alastair Smith, MD study director

INC Research/InVentiv Health

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DUR-928 in people with Primary Sclerosing Cholangitis, run by Durect at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change of Alkaline Phosphatase (ALP) From Baseline (time frame: Day 28 (end of treatment) and Day 56 (end of study/early termination)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03394781.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.