Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)

January 20, 2026 updated by: Pliant Therapeutics, Inc.

A Randomized, Double-blind, Dose-ranging, Placebo-controlled, Phase 2a Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Primary Sclerosing Cholangitis (PSC) and Suspected Liver Fibrosis (INTEGRIS-PSC)

A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Three-part study:

Part 1 - 12-week treatment period evaluating 40 mg of PLN-74809 or matching placebo [Complete] Part 2 - 12-week treatment period evaluating two dose groups, 80 mg and 160 mg of PLN-74809 or matching placebo Part 3 - minimum 24-week, up to 48-week treatment period evaluating 320 mg of PLN-74809 or matching placebo

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital: Department of Gastroenterology and Hepatology
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred
      • Melbourne, Victoria, Australia, 3065
        • St. Vincent's Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
  • Austria
      • Graz, Austria, 8036
        • Medizinische Universitat Graz
      • Vienna, Austria, A-1090
        • Medical University of Vienna Div. of Gastroenterology and Hepatology
  • Belgium
      • Brussels, Belgium, 1070
        • Department Gastroenterology, Hepatopancreatology and Digestive Oncology CUB Hôpital Erasme
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen
      • Ghent, Belgium, 9000
        • Ghent University Hospital
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3H 0V5
        • Aspen Woods Clinic
      • Edmonton, Alberta, Canada, T6G 2X8
        • University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • (G.I.R.I) GI Research Institute
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Centre
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre-University Hospital
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto Centre for Liver Disease (TCLD), University Health Network, Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)
      • Montreal, Quebec, Canada, H4A3J1
        • McGill University Health Centre
  • France
      • Grenoble, France, 38043 CEDEX 9
        • CHU Grenoble Alpes - Hôpital Michallon
      • Lille, France, 59037
        • CHU de Lille service MAD
      • Paris, France, 75012
        • Saint Antoine Hospital/ Hepatology Department
      • Strasbourg, France, 67200
        • C.H.U. Hautepierre
      • Villejuif, France, 94800
        • Centre Hépato-Biliaire - Hôpital Paul-Brousse
  • Germany
      • Berlin, Germany, 13353
        • Charité University Medicine Berlin
      • Erlangen, Germany, 91054
        • University Hospital Erlangen
      • Hamburg, Germany, 20246
        • University Medical Center Hamburg -Eppendorf/ I. Dept of Medicine
      • Heidelberg, Germany, 69120
        • University Hospital Heidelberg
      • Mainz, Germany, 55131
        • Universitätsmedizin Mainz, I. Med. Klinik
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Amsterdam UMC
      • Leiden, Netherlands, 2333 ZA
        • Leiden University Medical Center
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus University Medical Center
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • University Hospitals Birmingham NHS
      • London, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust, Denmark Hill
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospitals Nhs Foundation Trust
    • Oxford
      • Headington, Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital/Oxford University Hospital
  • United States
    • California
      • Pasadena, California, United States, 91105
        • California Liver Research Institute
      • Redwood City, California, United States, 94063
        • Stanford University School of Medicine
      • Sacramento, California, United States, 95817
        • University of California, Davis Medical Center
      • San Francisco, California, United States, 94143
        • University of California San Francisco
      • San Francisco, California, United States, 94109
        • California Pacific Medical Center Research Institute
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale School of Medicine
    • Florida
      • Lakewood Rch, Florida, United States, 34211
        • Florida Research Institute
      • Miami, Florida, United States, 33136
        • Schiff Center of Liver Diseases/University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Atlanta Hospital
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health University Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Gastroenterology Liver Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Novi, Michigan, United States, 48377
        • Henry Ford Health System
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Perelman Center for Advanced Medicine
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Digestive Disease Center
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine - Advanced Liver Therapies
    • Virginia
      • Newport News, Virginia, United States, 23602
        • Bon Secours Liver Institute of Hampton Roads
      • Richmond, Virginia, United States, 23298
        • VCU Health Clinical Research Services Unit
    • Washington
      • Seattle, Washington, United States, 98105
        • Liver Institute Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Established clinical diagnosis of large duct PSC based on an abnormal cholangiography as assessed by magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), and/or percutaneous transhepatic cholangiopancreatography (PTC) in the context of cholestatic liver chemistry
  • Suspected liver fibrosis, as defined by liver stiffness measurement (LSM), assessed by ultrasound-based transient elastography (TE, FibroScan®) OR Enhanced Liver Fibrosis (ELF) Score OR Historical liver biopsy showing fibrosis without cirrhosis (by any scoring system) OR Magnetic resonance elastography (MRE)
  • Serum ALP concentration within normal limits or > 1 times the upper limit of normal (ULN)
  • Participants receiving treatment for IBD are allowed, if on a stable dose from screening and expected to remain stable for the duration of the study
  • Serum AST and ALT concentration ≤ 5 times the upper limit of normal
  • If receiving treatment with UDCA, therapy is at a dose of < 25 mg/kg/day, has been stable for at least 3 months before screening.

Exclusion Criteria:

  • Other causes of liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically
  • Known or suspected overlapping clinical and histologic diagnosis of autoimmune hepatitis
  • Small duct PSC with no evidence of large duct involvement (evidence of PSC on historical liver histology, with normal bile ducts on cholangiography)
  • Presence of liver cirrhosis as assessed by liver histology, ultrasound-based liver stiffness measurement, ELF score, MRE, and/or signs and symptoms of hepatic decompensation (including but not limited to, jaundice, ascites, variceal hemorrhage, and/or hepatic encephalopathy.
  • Serum ALP concentration > 10 times the upper limit of normal.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo (Part 1, 2, and 3)
Drug: Placebo
Placebo
Experimental: PLN-74809 Dose Level 1
Part 1, Cohort 1 Dose: 40 mg, up to 12 weeks
Drug: PLN-74809
PLN-74809
Experimental: PLN-74809 Dose Level 2
Part 2, Cohort 2 Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
Drug: PLN-74809
PLN-74809
Experimental: PLN-74809 Dose Level 3
Part 2, Cohort 3 Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 1
Drug: PLN-74809
PLN-74809
Experimental: PLN-74809 Dose Level 4
Part 3, Cohort 4 Dose: 320 mg, for at least 24 weeks and up to 48 weeks; PLN-74809 Dose Level 4 following PLN-74809 Dose Levels 2 and 3
Drug: PLN-74809
PLN-74809

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events
Time Frame: Up to 40 weeks
Nature and proportion of TEAEs between PLN-74809 and placebo groups. Treatment-emergent adverse events (TEAEs) are defined as AEs that emerged or worsened in severity after the first administration of study drug
Up to 40 weeks
Number of Participants With Serious Treatment Emergent Adverse Events
Time Frame: Up to 40 weeks
Nature and proportion of Serious TEAEs between PLN-74809 and placebo groups. An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Up to 40 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of PLN-74809 Total Plasma Concentrations at Week 12
Time Frame: Up to 12 weeks
Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hour Post Dose
Up to 12 weeks
Assessment of PLN-74809 Total Plasma Concentrations at Week 24
Time Frame: Up to 24 weeks
Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hour Post Dose
Up to 24 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess Change From Baseline in Enhanced Liver Fibrosis (ELF) at Week 12
Time Frame: Baseline to week 12
Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens) which combines the 3 different tests that use 3 different units to produce a number that does not have a unit. ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome. ELF is a score of severity assessment against biopsy-proven fibrosis. A score of <7.7 is none to mild, >7.7-9.8 is moderate, >9.8 is severe.
Baseline to week 12
Assess Change From Baseline in Enhanced Liver Fibrosis (ELF) at Week 24
Time Frame: Baseline to week 24
Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens) which combines the 3 different tests that use 3 different units to produce a number that does not have a unit. ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome. ELF is a score of severity assessment against biopsy-proven fibrosis. A score of <7.7 is none to mild, >7.7-9.8 is moderate, >9.8 is severe.
Baseline to week 24
Assess Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12
Time Frame: Baseline to week 12
Liver function Serum Alkaline Phosphatase (ALP) Change from Baseline to Week 12
Baseline to week 12
Assess Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 24
Time Frame: Baseline to week 24
Liver function Serum Alkaline Phosphatase (ALP) Change from Baseline to Week 24
Baseline to week 24
Assess Percent Change From Baseline in PRO-C3 Liver Fibrosis Biomarker at Week 12
Time Frame: Baseline to week 12
Assess change in PRO-C3 liver fibrosis biomarker from Baseline to Week 12
Baseline to week 12
Assess Percent Change From Baseline in PRO-C3 Liver Fibrosis Biomarker at Week 24
Time Frame: Baseline to week 24
Assess change in PRO-C3 liver fibrosis biomarker from Baseline to Week 24
Baseline to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pliant Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pliant Therapeutics Medical Monitor, Pliant Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PLN-74809-PSC-203
  • INTEGRIS-PSC (Other Identifier: Pliant Therapeutics Inc)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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