Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
NCT ID: NCT04480840
Last Updated: 2024-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2020-07-27
2024-03-18
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
PLN-74809 Dose Level 1
Dose: 40 mg;
PLN-74809
PLN-74809
PLN-74809 Dose Level 2
Dose: 80 mg; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
PLN-74809
PLN-74809
PLN-74809 Dose Level 3
Dose: 160 mg; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809
PLN-74809
PLN-74809 Dose Level 4
Dose: 320 mg; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
PLN-74809
PLN-74809
Interventions
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PLN-74809
PLN-74809
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Pliant Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pliant Therapeutics Medical Monitor
Role: STUDY_DIRECTOR
Pliant Therapeutics, Inc.
Locations
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California Liver Research Institute
Pasadena, California, United States
Stanford University School of Medicine
Redwood City, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
California Pacific Medical Center Research Institute
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
Florida Research Institute
Lakewood Rch, Florida, United States
Schiff Center of Liver Diseases/University of Miami
Miami, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
Massachusetts General Hospital Gastroenterology Liver Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Novi, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Vanderbilt Digestive Disease Center
Nashville, Tennessee, United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, United States
Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, United States
VCU Health Clinical Research Services Unit
Richmond, Virginia, United States
Liver Institute Northwest
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Liverpool Hospital: Department of Gastroenterology and Hepatology
Liverpool, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred
Melbourne, Victoria, Australia
St. Vincent's Hospital
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Medizinische Universität Graz
Graz, , Austria
Medical University of Vienna Div. of Gastroenterology and Hepatology
Vienna, , Austria
Department Gastroenterology, Hepatopancreatology and Digestive Oncology CUB Hôpital Erasme
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Ghent University Hospital
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
Aspen Woods Clinic
Calgary, Alberta, Canada
University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
(G.I.R.I) GI Research Institute
Vancouver, British Columbia, Canada
McMaster University Medical Centre
Hamilton, Ontario, Canada
London Health Sciences Centre-University Hospital
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Toronto Centre for Liver Disease (TCLD), University Health Network, Toronto General Hospital
Toronto, Ontario, Canada
Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
CHU Grenoble Alpes - Hôpital Michallon
Grenoble, , France
CHU de Lille service MAD
Lille, , France
Saint Antoine Hospital/ Hepatology Department
Paris, , France
C.H.U. Hautepierre
Strasbourg, , France
Centre Hépato-Biliaire - Hôpital Paul-Brousse
Villejuif, , France
Charité University Medicine Berlin
Berlin, , Germany
University Hospital Erlangen
Erlangen, , Germany
University Medical Center Hamburg -Eppendorf/ I. Dept of Medicine
Hamburg, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
Universitätsmedizin Mainz, I. Med. Klinik
Mainz, , Germany
Amsterdam UMC
Amsterdam, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom
John Radcliffe Hospital/Oxford University Hospital
Headington, Oxford, United Kingdom
University Hospitals Birmingham NHS
Birmingham, , United Kingdom
King's College Hospital NHS Foundation Trust, Denmark Hill
London, , United Kingdom
Countries
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References
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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. 2025 Sep 26:S0168-8278(25)02498-5. doi: 10.1016/j.jhep.2025.09.016. Online ahead of print.
Other Identifiers
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INTEGRIS-PSC
Identifier Type: OTHER
Identifier Source: secondary_id
PLN-74809-PSC-203
Identifier Type: -
Identifier Source: org_study_id
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