Primary Sclerosing CholangitisPhase 2NCT04024813
A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC
A Phase 2 study testing Seladelpar in people with Primary Sclerosing Cholangitis, run by Gilead Sciences at 10 sites in 3 countries.
Trial summary
The objectives of this study are to evaluate the effect of seladelpar treatment compared to placebo on efficacy, safety, and tolerability in patients with primary sclerosing cholangitis (PSC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- Seladelpar
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 12 Nov 2019to 9 Jan 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of primary sclerosing cholangitis (PSC) based on any two of the following three criteria:
- Historical evidence of an elevated alkaline phosphatase (AP) > upper limit of normal (ULN) from any prior laboratory result
- Liver biopsy consistent with PSC
- Abnormal cholangiography consistent with PSC as measured by magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), or percutaneous transhepatic cholangiography (PTC)
- Individuals must have the following specific additional laboratory parameters measured by the Central Laboratory at Screening:
- AP ≥ 1.5 × ULN and < 8 × ULN
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- Total bilirubin ≤ 2 × ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN
- Estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73 m^2
- Platelets ≥ 140 × 10^3/µL
- International Normalized Ratio (INR) ≤ 1.3 (in the absence of warfarin or other anticoagulant therapy)
- Albumin ≥ 3.5 g/dL
- Patients taking ursodeoxycholic acid (UDCA) will be allowed to enroll if meeting the following criteria:
- Total daily dose of ≤ 20 mg/kg/day
- A minimum of 6 months of stable treatment
- Minimum of 12 weeks off treatment prior to Screening if UDCA is recently discontinued
Who cannot join
- Clinically significant acute or chronic liver disease of an etiology other than PSC
- Patients with a diagnosis of overlapping autoimmune hepatitis (AIH) and PSC
- Secondary or immunoglobulin G4 (IgG4) related sclerosing cholangitis
- Small duct PSC
- Presence of a cholangiocarcinoma on cholangiography or MRI at Screening as determined by the central radiologist and the principal investigator (PI) or medical monitor
- Bile duct stent or percutaneous bile duct drain placement, or balloon dilatation procedure of a stricture within 12 weeks of Screening
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- History, evidence, or high suspicion of cholangiocarcinoma or other hepatobiliary malignancy based on imaging, screening laboratory values, and/or clinical symptoms
- Presumptive or diagnosed acute cholangitis within 12 weeks of Screening and through Day 1
- Evidence of compensated or decompensated cirrhosis based on histology, relevant medical complications, or laboratory parameters:
- Historical liver biopsy demonstrating cirrhosis (eg, Ludwig Stage 4 or Ishak Stage 5)
- Current or prior history of decompensated liver disease, including ascites, hepatic encephalopathy, variceal bleeding or other clinical conditions consistent with cirrhosis and/or portal hypertension,
- Liver stiffness > 14.4 kPa by FibroScan, or
- Combined low platelet count (< 140 × 10^3/µL ) with one of the following:
- Serum albumin < 3.5 g/dL,
- INR > 1.3 (not due to antithrombotic agent use), or
- Total bilirubin > ULN
- Prior or actively listed for liver transplantation
- Prior exposure to seladelpar
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States8 sites
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
University of Colorado Denver and Hospital
Aurora, Colorado, 80045
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, 33136
New York University
New York, New York, 10016
Liver Institute of Virginia
Newport News, Virginia, 23602
Henry Ford Health System
Novi, Michigan, 48377
Bon Secours Liver Institute of Richmond
Richmond, Virginia, 23226
Sutter Pacific Medical Foundation - California Pacific Medical Center
San Francisco, California, 94109
Canada1 site
Toronto Centre for Liver Disease-Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: A Phase 2, Randomized, Double Blind, Placebo Controlled, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients With Primary Sclerosing Cholangitis (PSC)
The objectives of this study are to evaluate the effect of seladelpar treatment compared to placebo on efficacy, safety, and tolerability in patients with primary sclerosing cholangitis (PSC).
- Conditions
- Primary Sclerosing Cholangitis
- Being tested
- Seladelpar, Placebo to match Seladelpar
- Keywords
- PSC, Cholangitis, Sclerosing, Cholangitis, Bile Duct Diseases, Biliary Tract Diseases, Digestive System Diseases
- Medical subject headings
- Cholangitis, Sclerosing, Cholangitis, Bile Duct Diseases, Biliary Tract Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeladelparDrug
Also called MBX-8025, Livdelzi®
Capsule(s) administered orally once daily
Placebo to match SeladelparDrug
Capsule(s) administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo (N=25) | Placebo comparator | Placebo for the remainder of the study Receives: Drug: Placebo to match Seladelpar |
| Seladelpar 5 mg (N=25) | Experimental | 5 mg seladelpar daily for the remainder of the study Receives: Drug: Seladelpar |
| Seladelpar 10 mg (N=25) | Experimental | 10 mg seladelpar for the remainder of the study Receives: Drug: Seladelpar |
| Seladepar 25 mg (N=25) | Experimental | 25 mg seladelpar for the remainder of the study Receives: Drug: Seladelpar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Change in Baseline Serum Alkaline Phosphatase (AP) at Week 24
Measured: Baseline, Week 24
Secondary outcomes (3)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAEs were planned to be collected up to 24 weeks. Due to the early study termination, data is reported up to Day 59.
Measured: Up to Day 59
Incidence of Primary Sclerosing Cholangitis (PSC)-Related Symptoms or Procedures
Measured: Up to 24 weeks
Incidence of Hepatic Disease Progression Events
Hepatic disease progression events is defined by the first occurrence of the following events: liver transplantation, Model for End-Stage Liver Disease (MELD) score ≥ 15, hepatic decompensation events, and hepatocellular carcinoma.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start12 Nov 2019
- Primary completion9 Jan 2020
- Study completion9 Jan 2020
Why it stopped: Study was terminated as a precautionary measure due to histological findings in a nonalcoholic steatohepatitis (NASH) study (CB8025-21730, NCT03551522).
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.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024813
- Sponsor's protocol ID
- CB8025-21845
- Other IDs
- 2019-001760-30, 2019
- Status last verified
- Jan 2025
- First submitted
- 20 Jun 2019
- Last updated
- 16 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double Blind, Placebo Controlled, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients With Primary Sclerosing Cholangitis (PSC)
- ClinicalTrials.gov ID
- NCT04024813
- Acronym / sponsor ID
- CB8025-21845
- Conditions
- Primary Sclerosing Cholangitis
- Keywords
- PSC, Cholangitis, Sclerosing, Cholangitis, Bile Duct Diseases, Biliary Tract Diseases, Digestive System Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated as a precautionary measure due to histological findings in a nonalcoholic steatohepatitis (NASH) study (CB8025-21730, NCT03551522).
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 9 Jan 2020 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Posted 16 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to evaluate the effect of seladelpar treatment compared to placebo on efficacy, safety, and tolerability in patients with primary sclerosing cholangitis (PSC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo (N=25) | Placebo comparator | Drug: Placebo to match SeladelparPlacebo for the remainder of the study |
| Seladelpar 5 mg (N=25) | Experimental | Drug: Seladelpar5 mg seladelpar daily for the remainder of the study |
| Seladelpar 10 mg (N=25) | Experimental | Drug: Seladelpar10 mg seladelpar for the remainder of the study |
| Seladepar 25 mg (N=25) | Experimental | Drug: Seladelpar25 mg seladelpar for the remainder of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Confirmed diagnosis of primary sclerosing cholangitis (PSC) based on any two of the following three criteria:
- Individuals must have the following specific additional laboratory parameters measured by the Central Laboratory at Screening:
- Patients taking ursodeoxycholic acid (UDCA) will be allowed to enroll if meeting the following criteria:
Key exclusion criteria (19 listed)
- Clinically significant acute or chronic liver disease of an etiology other than PSC
- Patients with a diagnosis of overlapping autoimmune hepatitis (AIH) and PSC
- Secondary or immunoglobulin G4 (IgG4) related sclerosing cholangitis
- Small duct PSC
- Presence of a cholangiocarcinoma on cholangiography or MRI at Screening as determined by the central radiologist and the principal investigator (PI) or medical monitor
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 |
|---|---|---|
| SeladelparAlso: MBX-8025, Livdelzi®Capsule(s) administered orally once daily | Drug | Seladelpar 10 mg (N=25), Seladelpar 5 mg (N=25), Seladepar 25 mg (N=25) |
| Placebo to match SeladelparCapsule(s) administered orally once daily | Drug | Placebo (N=25) |
Primary outcome
Relative Change in Baseline Serum Alkaline Phosphatase (AP) at Week 24
Time frame: Baseline, Week 24
3 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 59
Incidence of Primary Sclerosing Cholangitis (PSC)-Related Symptoms or Procedures
Time frame: Up to 24 weeks
Incidence of Hepatic Disease Progression Events
Time frame: Up to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gilead Study Director study director
Gilead Sciences
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Seladelpar in people with Primary Sclerosing Cholangitis, run by Gilead Sciences at 10 sites in 3 countries.
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 16 inclusion and 19 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 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Poland. 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. Some participants in this study may receive a placebo. 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 16 Jan 2025). 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?
Relative Change in Baseline Serum Alkaline Phosphatase (AP) at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2025.