<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04480840</url>
  </required_header>
  <id_info>
    <org_study_id>PLN-74809-PSC-203</org_study_id>
    <secondary_id>INTEGRIS-PSC</secondary_id>
    <nct_id>NCT04480840</nct_id>
  </id_info>
  <brief_title>Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)</brief_title>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pliant Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pliant Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to&#xD;
      evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary&#xD;
      sclerosing cholangitis and suspected liver fibrosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Three-part study:&#xD;
&#xD;
      Part 1 - 12-week treatment period evaluating 40 mg of PLN-74809 or matching placebo&#xD;
      [Complete] Part 2 - 12-week treatment period evaluating two dose groups, 80 mg and 160 mg of&#xD;
      PLN-74809 or matching placebo Part 3 - minimum 24-week, up to 48-week treatment period&#xD;
      evaluating 320 mg of PLN-74809 or matching placebo&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0</measure>
    <time_frame>12-48 weeks</time_frame>
    <description>Nature and proportion of AEs between PLN-74809 and placebo groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of PLN-74809 plasma concentrations</measure>
    <time_frame>12-48 weeks</time_frame>
    <description>Plasma PLN-74809 concentrations (total and unbound concentrations) at each sampling timepoint</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes from Baseline to Week 12 in liver fibrosis biomarkers and alkaline phosphatase (ALP) levels</measure>
    <time_frame>12-48 Weeks</time_frame>
    <description>Absolute and relative changes from Baseline to Week 12 in liver fibrosis biomarkers (including PRO-C3 and ELF) and in ALP</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">112</enrollment>
  <condition>Primary Sclerosing Cholangitis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PLN-74809 Dose Level 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose: 40 mg;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLN-74809 Dose Level 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose: 80 mg; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLN-74809 Dose Level 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose: 160 mg; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PLN-74809 Dose Level 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose: 320 mg; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PLN-74809</intervention_name>
    <description>PLN-74809</description>
    <arm_group_label>PLN-74809 Dose Level 1</arm_group_label>
    <arm_group_label>PLN-74809 Dose Level 2</arm_group_label>
    <arm_group_label>PLN-74809 Dose Level 3</arm_group_label>
    <arm_group_label>PLN-74809 Dose Level 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Established clinical diagnosis of large duct PSC based on an abnormal cholangiography&#xD;
             as assessed by magnetic resonance cholangiopancreatography (MRCP), endoscopic&#xD;
             retrograde cholangiopancreatography (ERCP), and/or percutaneous transhepatic&#xD;
             cholangiopancreatography (PTC) in the context of cholestatic liver chemistry&#xD;
&#xD;
          -  Suspected liver fibrosis, as defined by liver stiffness measurement (LSM), assessed by&#xD;
             ultrasound-based transient elastography (TE, FibroScan®) OR Enhanced Liver Fibrosis&#xD;
             (ELF) Score OR Historical liver biopsy showing fibrosis without cirrhosis (by any&#xD;
             scoring system) OR Magnetic resonance elastography (MRE)&#xD;
&#xD;
          -  Serum ALP concentration within normal limits or &gt; 1 times the upper limit of normal&#xD;
             (ULN)&#xD;
&#xD;
          -  Participants receiving treatment for IBD are allowed, if on a stable dose from&#xD;
             screening and expected to remain stable for the duration of the study&#xD;
&#xD;
          -  Serum AST and ALT concentration ≤ 5 times the upper limit of normal&#xD;
&#xD;
          -  If receiving treatment with UDCA, therapy is at a dose of &lt; 25 mg/kg/day, has been&#xD;
             stable for at least 3 months before screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other causes of liver disease, including secondary sclerosing cholangitis or viral,&#xD;
             metabolic, or alcoholic liver disease, as assessed clinically&#xD;
&#xD;
          -  Known or suspected overlapping clinical and histologic diagnosis of autoimmune&#xD;
             hepatitis&#xD;
&#xD;
          -  Small duct PSC with no evidence of large duct involvement (evidence of PSC on&#xD;
             historical liver histology, with normal bile ducts on cholangiography)&#xD;
&#xD;
          -  Presence of liver cirrhosis as assessed by liver histology, ultrasound-based liver&#xD;
             stiffness measurement, ELF score, MRE, and/or signs and symptoms of hepatic&#xD;
             decompensation (including but not limited to, jaundice, ascites, variceal hemorrhage,&#xD;
             and/or hepatic encephalopathy.&#xD;
&#xD;
          -  Serum ALP concentration &gt; 10 times the upper limit of normal.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pliant Therapeutics Medical Monitor</last_name>
    <role>Study Director</role>
    <affiliation>Pliant Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>California Liver Research Institute</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Pacific Medical Center Research Institute</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Research Institute</name>
      <address>
        <city>Lakewood Ranch</city>
        <state>Florida</state>
        <zip>34211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schiff Center of Liver Diseases/University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Atlanta Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Health University Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital Gastroenterology Liver Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Novi</city>
        <state>Michigan</state>
        <zip>48377</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Perelman Center for Advanced Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Digestive Disease Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine - Advanced Liver Therapies</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bon Secours Liver Institute of Hampton Roads</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VCU Health Clinical Research Services Unit</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liver Institute Northwest</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liverpool Hospital: Department of Gastroenterology and Hepatology</name>
      <address>
        <city>Liverpool</city>
        <state>New South Wales</state>
        <zip>2170</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Alfred</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Charles Gairdner Hospital</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of Vienna Div. of Gastroenterology and Hepatology</name>
      <address>
        <city>Vienna</city>
        <zip>A-1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department Gastroenterology, Hepatopancreatology and Digestive Oncology CUB Hôpital Erasme</name>
      <address>
        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Antwerpen</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspen Woods Clinic</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3H 0V5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(G.I.R.I) GI Research Institute</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 2K5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McMaster University Medical Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre-University Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Centre for Liver Disease (TCLD), University Health Network, Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM)</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4A3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble Alpes - Hôpital Michallon</name>
      <address>
        <city>Grenoble</city>
        <zip>38043 CEDEX 9</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Lille service MAD</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Antoine Hospital/ Hepatology Department</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H.U. Hautepierre</name>
      <address>
        <city>Strasbourg</city>
        <zip>67200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hépato-Biliaire - Hôpital Paul-Brousse</name>
      <address>
        <city>Villejuif</city>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité University Medicine Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Hamburg -Eppendorf/ I. Dept of Medicine</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Mainz, I. Med. Klinik</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus University Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norfolk and Norwich University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Norwich</city>
        <state>Norfolk</state>
        <zip>NR4 7UY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Radcliffe Hospital/Oxford University Hospital</name>
      <address>
        <city>Headington</city>
        <state>Oxford</state>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2GW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital NHS Foundation Trust, Denmark Hill</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 14, 2023</last_update_submitted>
  <last_update_submitted_qc>July 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangitis</mesh_term>
    <mesh_term>Cholangitis, Sclerosing</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04480840
org study id: PLN-74809-PSC-203
secondary id: INTEGRIS-PSC
nct id: NCT04480840
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0
time frame: 12-48 weeks
description: Nature and proportion of AEs between PLN-74809 and placebo groups
measure: Assessment of PLN-74809 plasma concentrations
time frame: 12-48 weeks
description: Plasma PLN-74809 concentrations (total and unbound concentrations) at each sampling timepoint
measure: Changes from Baseline to Week 12 in liver fibrosis biomarkers and alkaline phosphatase (ALP) levels
time frame: 12-48 Weeks
description: Absolute and relative changes from Baseline to Week 12 in liver fibrosis biomarkers (including PRO-C3 and ELF) and in ALP
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: PLN-74809 Dose Level 1
arm group type: Experimental
description: Dose: 40 mg;
arm group label: PLN-74809 Dose Level 2
arm group type: Experimental
description: Dose: 80 mg; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
arm group label: PLN-74809 Dose Level 3
arm group type: Experimental
description: Dose: 160 mg; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
arm group label: PLN-74809 Dose Level 4
arm group type: Experimental
description: Dose: 320 mg; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
intervention type: Drug
intervention name: PLN-74809
description: PLN-74809
arm group label: PLN-74809 Dose Level 1
arm group label: PLN-74809 Dose Level 2
arm group label: PLN-74809 Dose Level 3
arm group label: PLN-74809 Dose Level 4
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Pliant Therapeutics Medical Monitor
role: Study Director
affiliation: Pliant Therapeutics, Inc.
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country: Australia
country: Austria
country: Belgium
country: Canada
country: France
country: Germany
country: Netherlands
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Cholangitis
mesh term: Cholangitis, Sclerosing
sharing ipd: No