Primary Sclerosing CholangitisPhase 2NCT04480840
Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
A Phase 2 study testing PLN-74809 in people with Primary Sclerosing Cholangitis, run by Pliant Therapeutics, Inc. at 60 sites in 9 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- PLN-74809
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 60 sitesin 9 countries
- Study dates
- 27 Jul 2020to 18 Mar 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
60 sites in 9 countries.
60 sites in 9 countries
United States21 sites
University of Michigan
Ann Arbor, Michigan, 48109
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
Massachusetts General Hospital Gastroenterology Liver Center
Boston, Massachusetts, 02114
University of Chicago Medical Center
Chicago, Illinois, 60637
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, 77030
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
Florida Research Institute
Lakewood Rch, Florida, 34211
Schiff Center of Liver Diseases/University of Miami
Miami, Florida, 33136
Vanderbilt Digestive Disease Center
Nashville, Tennessee, 37232
Yale School of Medicine
New Haven, Connecticut, 06511
Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, 23602
Henry Ford Health System
Novi, Michigan, 48377
California Liver Research Institute
Pasadena, California, 91105
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
Stanford University School of Medicine
Redwood City, California, 94063
VCU Health Clinical Research Services Unit
Richmond, Virginia, 23298
University of California, Davis Medical Center
Sacramento, California, 95817
California Pacific Medical Center Research Institute
San Francisco, California, 94109
University of California San Francisco
San Francisco, California, 94143
Liver Institute Northwest
Seattle, Washington, 98105
Canada9 sites
Aspen Woods Clinic
Calgary, Alberta, T3H 0V5
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre
Edmonton, Alberta, T6G 2X8
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
London Health Sciences Centre-University Hospital
London, Ontario, N6A 5A5
Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
Montreal, Quebec, H2X 0A9
McGill University Health Centre
Montreal, Quebec, H4A3J1
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Toronto Centre for Liver Disease (TCLD), University Health Network, Toronto General Hospital
Toronto, Ontario, M5G 2C4
(G.I.R.I) GI Research Institute
Vancouver, British Columbia, V6Z 2K5
Australia7 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Liverpool Hospital: Department of Gastroenterology and Hepatology
Liverpool, New South Wales, 2170
The Alfred
Melbourne, Victoria, 3004
St. Vincent's Hospital
Melbourne, Victoria, 3065
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Westmead Hospital
Westmead, New South Wales, 2145
France5 sites
CHU Grenoble Alpes - Hôpital Michallon
Grenoble, 38043 CEDEX 9
CHU de Lille service MAD
Lille, 59037
Saint Antoine Hospital/ Hepatology Department
Paris, 75012
C.H.U. Hautepierre
Strasbourg, 67200
Centre Hépato-Biliaire - Hôpital Paul-Brousse
Villejuif, 94800
Germany5 sites
Charité University Medicine Berlin
Berlin, 13353
University Hospital Erlangen
Erlangen, 91054
University Medical Center Hamburg -Eppendorf/ I. Dept of Medicine
Hamburg, 20246
University Hospital Heidelberg
Heidelberg, 69120
Universitätsmedizin Mainz, I. Med. Klinik
Mainz, 55131
Belgium4 sites
Department Gastroenterology, Hepatopancreatology and Digestive Oncology CUB Hôpital Erasme
Brussels, 1070
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Ghent University Hospital
Ghent, 9000
UZ Leuven
Leuven, 3000
United Kingdom4 sites
University Hospitals Birmingham NHS
Birmingham, B15 2GW
John Radcliffe Hospital/Oxford University Hospital
Headington, Oxford, OX3 9DU
King's College Hospital NHS Foundation Trust, Denmark Hill
London, SE5 9RS
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
Netherlands3 sites
Amsterdam UMC
Amsterdam, 1105 AZ
Leiden University Medical Center
Leiden, 2333 ZA
Erasmus University Medical Center
Rotterdam, 3015 GD
Austria2 sites
Medizinische Universität Graz
Graz, 8036
Medical University of Vienna Div. of Gastroenterology and Hepatology
Vienna, A-1090
About this study
Official title: 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
Read the 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
- Conditions
- Primary Sclerosing Cholangitis
- Being tested
- PLN-74809, Placebo
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLN-74809Drug
PLN-74809
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (Part 1, 2, and 3) Receives: Drug: Placebo |
| PLN-74809 Dose Level 1 | Experimental | Part 1, Cohort 1 Dose: 40 mg, up to 12 weeks Receives: Drug: PLN-74809 |
| PLN-74809 Dose Level 2 | Experimental | Part 2, Cohort 2 Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1 Receives: Drug: PLN-74809 |
| PLN-74809 Dose Level 3 | Experimental | Part 2, Cohort 3 Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 1 Receives: Drug: PLN-74809 |
| PLN-74809 Dose Level 4 | Experimental | 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 Receives: Drug: PLN-74809 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events
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
Measured: Up to 40 weeks
Number of Participants With Serious Treatment Emergent Adverse Events
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.
Measured: Up to 40 weeks
Secondary outcomes (2)
Assessment of PLN-74809 Total Plasma Concentrations at Week 12
Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hour Post Dose
Measured: Up to 12 weeks
Assessment of PLN-74809 Total Plasma Concentrations at Week 24
Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hour Post Dose
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 posted21 Jul 2020
- Study start27 Jul 2020
- Primary completion26 Feb 2024
- Study completion18 Mar 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pliant Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pliant Therapeutics Medical Monitor, Study director, Pliant Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480840
- Sponsor's protocol ID
- PLN-74809-PSC-203
- Other IDs
- INTEGRIS-PSC
- Status last verified
- Jan 2026
- First submitted
- 13 Jul 2020
- Last updated
- 23 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hirschfield GM, Kowdley KV, Trivedi PJ, Eksteen B, Hameed B, Vincent C, Chen T, Goel A, Reddy KG, Orman E, Joshi D, Lefebvre EA, Schaub JR, An MC, Clark A, Barnes CN, Pencek R, Thorburn D, Montano-Loza AJ, Schramm C, Bowlus CL, Trauner M, Levy C. Phase II INTEGRIS-PSC trial of bexotegrast, an alphavbeta6/alphavbeta1 integrin inhibitor, in primary sclerosing cholangitis. J Hepatol. 2026 Jan;84(1):86-98. doi: 10.1016/j.jhep.2025.09.016. Epub 2025 Sep 26.
PubMed 41016442
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04480840
- Acronym / sponsor ID
- PLN-74809-PSC-203
- Conditions
- Primary Sclerosing Cholangitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Pliant Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Posted 23 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (Part 1, 2, and 3) |
| PLN-74809 Dose Level 1 | Experimental | Drug: PLN-74809Part 1, Cohort 1 Dose: 40 mg, up to 12 weeks |
| PLN-74809 Dose Level 2 | Experimental | Drug: PLN-74809Part 2, Cohort 2 Dose: 80 mg, up to 12 weeks; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1 |
| PLN-74809 Dose Level 3 | Experimental | Drug: PLN-74809Part 2, Cohort 3 Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 1 |
| PLN-74809 Dose Level 4 | Experimental | Drug: PLN-74809Part 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| PLN-74809PLN-74809 | Drug | PLN-74809 Dose Level 1, PLN-74809 Dose Level 2, PLN-74809 Dose Level 3, PLN-74809 Dose Level 4 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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
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.
2 secondary outcomes
Assessment of PLN-74809 Total Plasma Concentrations at Week 12
Time frame: Up to 12 weeks
Assessment of PLN-74809 Total Plasma Concentrations at Week 24
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 23 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41016442Hirschfield GM, Kowdley KV, Trivedi PJ, Eksteen B, Hameed B, Vincent C, Chen T, Goel A, Reddy KG, Orman E, Joshi D, Lefebvre EA, Schaub JR, An MC, Clark A, Barnes CN, Pencek R, Thorburn D, Montano-Loza AJ, Schramm C, Bowlus CL, Trauner M, Levy C. Phase II INTEGRIS-PSC trial of bexotegrast, an alphavbeta6/alphavbeta1 integrin inhibitor, in primary sclerosing cholangitis. J Hepatol. 2026 Jan;84(1):86-98. doi: 10.1016/j.jhep.2025.09.016. Epub 2025 Sep 26.
- 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.
Pliant Therapeutics Medical Monitor study director
Pliant Therapeutics, Inc.
60 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PLN-74809 in people with Primary Sclerosing Cholangitis, run by Pliant Therapeutics, Inc. at 60 sites in 9 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Canada, Australia, France, Germany and 4 more countries. 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 23 Jan 2026). 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?
Number of Participants With Treatment Emergent Adverse Events (time frame: Up to 40 weeks). The study lists 2 primary outcomes in all. 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 NCT04480840, which also lists 1 linked publication.
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 23 Jan 2026.