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| ID | Type | Description | Link |
|---|---|---|---|
| INTEGRIS-PSC | Other Identifier | Pliant Therapeutics Inc |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (Part 1, 2, and 3) |
|
| PLN-74809 Dose Level 1 | Experimental | Part 1, Cohort 1 Dose: 40 mg, up to 12 weeks |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLN-74809 | Drug | PLN-74809 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Up to 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of PLN-74809 Total Plasma Concentrations at Week 12 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess Change From Baseline in Enhanced Liver Fibrosis (ELF) at 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pliant Therapeutics Medical Monitor | Pliant Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Liver Research Institute | Pasadena | California | 91105 | United States | ||
| Stanford University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41016442 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Placebo (Part 1, 2, and 3) |
| FG001 | PLN-74809 Dose Level 1 | Part 1, Cohort 1 Dose: 40 mg, up to 12 weeks PLN-74809: PLN-74809 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 9, 2023 | Feb 25, 2025 |
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| Placebo | Drug | Placebo |
|
Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hour Post Dose
| Up to 24 weeks |
| Baseline to week 12 |
| Assess Change From Baseline in Enhanced Liver Fibrosis (ELF) at 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 | 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 | 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 | 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 | Assess change in PRO-C3 liver fibrosis biomarker from Baseline to Week 24 | Baseline to week 24 |
| Redwood City |
| California |
| 94063 |
| United States |
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States |
| California Pacific Medical Center Research Institute | San Francisco | California | 94109 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06511 | United States |
| Florida Research Institute | Lakewood Rch | Florida | 34211 | United States |
| Schiff Center of Liver Diseases/University of Miami | Miami | Florida | 33136 | United States |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202 | United States |
| Massachusetts General Hospital Gastroenterology Liver Center | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Novi | Michigan | 48377 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt Digestive Disease Center | Nashville | Tennessee | 37232 | United States |
| Baylor College of Medicine - Advanced Liver Therapies | Houston | Texas | 77030 | United States |
| Bon Secours Liver Institute of Hampton Roads | Newport News | Virginia | 23602 | United States |
| VCU Health Clinical Research Services Unit | Richmond | Virginia | 23298 | United States |
| Liver Institute Northwest | Seattle | Washington | 98105 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Liverpool Hospital: Department of Gastroenterology and Hepatology | Liverpool | New South Wales | 2170 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| The Alfred | Melbourne | Victoria | 3004 | Australia |
| St. Vincent's Hospital | Melbourne | Victoria | 3065 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Medizinische Universität Graz | Graz | 8036 | Austria |
| Medical University of Vienna Div. of Gastroenterology and Hepatology | Vienna | A-1090 | Austria |
| Department Gastroenterology, Hepatopancreatology and Digestive Oncology CUB Hôpital Erasme | Brussels | 1070 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| Ghent University Hospital | Ghent | 9000 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Aspen Woods Clinic | Calgary | Alberta | T3H 0V5 | Canada |
| University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre | Edmonton | Alberta | T6G 2X8 | Canada |
| (G.I.R.I) GI Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| McMaster University Medical Centre | Hamilton | Ontario | L8N 3Z5 | Canada |
| London Health Sciences Centre-University Hospital | London | Ontario | N6A 5A5 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto Centre for Liver Disease (TCLD), University Health Network, Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM) | Montreal | Quebec | H2X 0A9 | Canada |
| McGill University Health Centre | Montreal | Quebec | H4A3J1 | Canada |
| CHU Grenoble Alpes - Hôpital Michallon | Grenoble | 38043 CEDEX 9 | France |
| CHU de Lille service MAD | Lille | 59037 | France |
| Saint Antoine Hospital/ Hepatology Department | Paris | 75012 | France |
| C.H.U. Hautepierre | Strasbourg | 67200 | France |
| Centre Hépato-Biliaire - Hôpital Paul-Brousse | Villejuif | 94800 | France |
| Charité University Medicine Berlin | Berlin | 13353 | Germany |
| University Hospital Erlangen | Erlangen | 91054 | Germany |
| University Medical Center Hamburg -Eppendorf/ I. Dept of Medicine | Hamburg | 20246 | Germany |
| University Hospital Heidelberg | Heidelberg | 69120 | Germany |
| Universitätsmedizin Mainz, I. Med. Klinik | Mainz | 55131 | Germany |
| Amsterdam UMC | Amsterdam | 1105 AZ | Netherlands |
| Leiden University Medical Center | Leiden | 2333 ZA | Netherlands |
| Erasmus University Medical Center | Rotterdam | 3015 GD | Netherlands |
| Norfolk and Norwich University Hospitals NHS Foundation Trust | Norwich | Norfolk | NR4 7UY | United Kingdom |
| John Radcliffe Hospital/Oxford University Hospital | Headington | Oxford | OX3 9DU | United Kingdom |
| University Hospitals Birmingham NHS | Birmingham | B15 2GW | United Kingdom |
| King's College Hospital NHS Foundation Trust, Denmark Hill | London | SE5 9RS | United Kingdom |
| FG002 | 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 PLN-74809: PLN-74809 |
| FG003 | 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 2 PLN-74809: PLN-74809 |
| FG004 | 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 Level 3 PLN-74809: PLN-74809 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population included all participants who took at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Placebo (Part 1, 2, and 3) |
| BG001 | PLN-74809 Dose Level 1 | Part 1, Cohort 1 Dose: 40 mg, up to 12 weeks PLN-74809: PLN-74809 |
| BG002 | 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 PLN-74809: PLN-74809 |
| BG003 | 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 2 PLN-74809: PLN-74809 |
| BG004 | 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 Level 3 PLN-74809: PLN-74809 |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| BMI at Screening | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Safety Population included all participants who took at least 1 dose of study drug | Posted | Count of Participants | Participants | Up to 40 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Safety Population included all participants who took at least 1 dose of study drug | Posted | Count of Participants | Participants | Up to 40 weeks |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Assessment of PLN-74809 Total Plasma Concentrations at Week 12 | Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hour Post Dose | Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration. | Posted | Mean | Standard Deviation | ng/mL | Up to 12 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Assessment of PLN-74809 Total Plasma Concentrations at Week 24 | Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hour Post Dose | Only the dose level 4 and matching placebo cohorts had a treatment period of 24 weeks and were assessed at 24 weeks. Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration. | Posted | Mean | Standard Deviation | ng/mL | Up to 24 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Assess Change From Baseline in Enhanced Liver Fibrosis (ELF) at 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. | Mean change from baseline in Enhanced Liver Fibrosis Score was assessed in the Full Analysis Set. | Posted | Mean | Standard Deviation | Unitless | Baseline to week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Assess Change From Baseline in Enhanced Liver Fibrosis (ELF) at 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. | Mean change from baseline in Enhanced Liver Fibrosis Score was assessed in the Full Analysis Set. Only the dose level 4 and matching placebo cohorts had a treatment period of 24 weeks and were assessed at 24 weeks. Participants with baseline and at least one post baseline assessment | Posted | Mean | Standard Deviation | Unitless | Baseline to week 24 |
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Assess Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12 | Liver function Serum Alkaline Phosphatase (ALP) Change from Baseline to Week 12 | Participants with baseline and at least one post baseline assessment | Posted | Mean | Standard Deviation | U/L | Baseline to week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Assess Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 24 | Liver function Serum Alkaline Phosphatase (ALP) Change from Baseline to Week 24 | Only the dose level 4 and matching placebo cohorts had a treatment period of 24 weeks and were assessed at 24 weeks. Participants with baseline and at least one post baseline assessment | Posted | Mean | Standard Deviation | U/L | Baseline to week 24 |
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Assess Percent Change From Baseline in PRO-C3 Liver Fibrosis Biomarker at Week 12 | Assess change in PRO-C3 liver fibrosis biomarker from Baseline to Week 12 | Participants with baseline and at least one post baseline assessment | Posted | Mean | Standard Deviation | Percent Change | Baseline to week 12 |
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Assess Percent Change From Baseline in PRO-C3 Liver Fibrosis Biomarker at Week 24 | Assess change in PRO-C3 liver fibrosis biomarker from Baseline to Week 24 | Only the dose level 4 and matching placebo cohorts had a treatment period of 24 weeks and were assessed at 24 weeks. Participants with baseline and at least one post baseline assessment | Posted | Mean | Standard Deviation | Percent Change | Baseline to week 24 |
|
Up to 40 weeks
All-cause mortality: All Randomized population included all participants who were randomized in the study.
Adverse Events: Safety population included all participants who took at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: Placebo (Part 1, 2, and 3) | 0 | 30 | 1 | 30 | 21 | 30 |
| EG001 | PLN-74809 Dose Level 1 | Part 1, Cohort 1 Dose: 40 mg, up to 12 weeks PLN-74809: PLN-74809 | 0 | 24 | 1 | 24 | 10 | 24 |
| EG002 | 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 PLN-74809: PLN-74809 | 0 | 20 | 1 | 20 | 16 | 20 |
| EG003 | 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 2 PLN-74809: PLN-74809 | 0 | 20 | 0 | 20 | 15 | 20 |
| EG004 | 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 Level 3 PLN-74809: PLN-74809 | 0 | 27 | 1 | 27 | 23 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholangitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Enterobacter bacteramia | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colitis ulcerative | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Frequent bowel movements | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Cholangitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Ocular icterus | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
|
Per protocol, the data generated in this clinical study are the exclusive property of the Sponsor and are confidential. Any publication of the results of this study must be authorized by the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pliant Therapeutics Medical Monitor | Pliant Therapeutics | 650-481-6770 | clintrials@pliantrx.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 4, 2023 | Aug 15, 2025 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D015209 | Cholangitis, Sclerosing |
| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Austria |
|
| Netherlands |
|
| Belgium |
|
| United States |
|
| United Kingdom |
|
| Australia |
|
| France |
|
| Germany |
|
Part 2, Cohort 3
Dose: 160 mg, up to 12 weeks; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
PLN-74809: PLN-74809
| OG004 | 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 Level 3 PLN-74809: PLN-74809 |
|
|
| OG004 |
| 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 Level 3 PLN-74809: PLN-74809 |
|
|
| OG004 | 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 Level 3 PLN-74809: PLN-74809 |
|
|
| OG003 | 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 2 PLN-74809: PLN-74809 |
| OG004 | 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 Level 3 PLN-74809: PLN-74809 |
|
|
| 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 PLN-74809: PLN-74809 |
| OG003 | 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 2 PLN-74809: PLN-74809 |
| OG004 | 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 Level 3 PLN-74809: PLN-74809 |
|
|
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 Level 3 PLN-74809: PLN-74809 |
|
|
| OG004 | 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 Level 3 PLN-74809: PLN-74809 |
|
|
| 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 Level 3 PLN-74809: PLN-74809 |
|
|
| OG004 | 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 Level 3 PLN-74809: PLN-74809 |
|
|