<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/NCT04419558</url>
  </required_header>
  <id_info>
    <org_study_id>FGCL-3019-095</org_study_id>
    <nct_id>NCT04419558</nct_id>
  </id_info>
  <brief_title>Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)</brief_title>
  <official_title>Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FibroGen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>FibroGen</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>
      This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram&#xD;
      (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to&#xD;
      placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week&#xD;
      randomized treatment phase followed by an optional, open-label extension phase.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intent of this study is to evaluate the efficacy and safety of pamrevlumab as monotherapy&#xD;
      in participants with IPF. Participants who are not being treated with approved IPF therapies&#xD;
      (that is, nintedanib or pirfenidone) may be eligible for screening. Examples of reasons&#xD;
      participants may not be treated with approved IPF therapies include but are not limited to:&#xD;
&#xD;
        -  Intolerant or not responsive to approved IPF therapies&#xD;
&#xD;
        -  Ineligible to receive these therapies&#xD;
&#xD;
        -  Participant voluntarily declines to receive approved IPF therapies after being fully&#xD;
           informed of the potential benefits/risks&#xD;
&#xD;
      NOTE: No participant should discontinue an approved IPF therapy for the purpose of enrolling&#xD;
      in this study.&#xD;
&#xD;
      During the 48-week treatment phase of the study, co-administration of an approved IPF therapy&#xD;
      (such as, pirfenidone or nintedanib) is acceptable if clinically indicated in the&#xD;
      Investigator's opinion, after assessment of potential risks/benefits of such combination with&#xD;
      blinded study treatment.&#xD;
&#xD;
      Participants who complete the 48-week study will be eligible for an optional, open-label&#xD;
      extension phase with continued access to pamrevlumab, regardless of their randomized&#xD;
      assignment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 30, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2024</primary_completion_date>
  <phase>Phase 3</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>
    <masking_description>During the Open-label extension phase, all participants will receive pamrevlumab in an open-label manner. No unblinding of participant's treatment assignment in the treatment phase (main study) will occur for purposes of open-label extension participation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Forced Vital Capacity (FVC) at Week 48</measure>
    <time_frame>Baseline, Week 48</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Disease Progression</measure>
    <time_frame>Up to Week 48</time_frame>
    <description>Defined as absolute FVC percent predicted (FVCpp) decline of ≥10% or death, whichever occurs first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline to Week 48 in Quantitative Lung Fibrosis (QLF) Volume</measure>
    <time_frame>Baseline, Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Any Component of the Clinical Composite Endpoint, Whichever Occurs First: Acute IPF Exacerbation, Respiratory Hospitalization, or Death</measure>
    <time_frame>Up to Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Acute IPF Exacerbation</measure>
    <time_frame>Up to Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to All-Cause Mortality</measure>
    <time_frame>Up to Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Respiratory Hospitalization</measure>
    <time_frame>Up to Week 48</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">372</enrollment>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <arm_group>
    <arm_group_label>Pamrevlumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment phase: Pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks.&#xD;
Open-label extension phase: Pamrevlumab 30 mg/kg administered by intravenous infusion, every 3 weeks for up to 48 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pamrevlumab-matching placebo administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pamrevlumab</intervention_name>
    <description>Sterile solution for injection</description>
    <arm_group_label>Pamrevlumab</arm_group_label>
    <other_name>FG-3019</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sterile solution for injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory&#xD;
             Society/Japanese Respiratory Society/Latin American Thoracic Association&#xD;
             (ATS/ERS/JRS/ALAT) guidelines within the past 7 years prior to study participation.&#xD;
&#xD;
          2. High-resolution computed tomography (HRCT) scan at Screening, with ≥10% to &lt;50%&#xD;
             parenchymal fibrosis (reticulation) and &lt;25% honeycombing.&#xD;
&#xD;
          3. FVCpp value &gt;45% and &lt;95% at Screening and Day 1 (prior to randomization).&#xD;
&#xD;
          4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and&#xD;
             ≤90%.&#xD;
&#xD;
          5. Not currently receiving treatment for IPF with an approved therapy for IPF (such as,&#xD;
             pirfenidone or nintedanib) for any reason, including prior intolerance or lack of&#xD;
             response to an approved IPF therapy, or choice to forego treatment with an approved&#xD;
             IPF therapy after a full discussion with the Investigator regarding risks/benefits of&#xD;
             such therapy.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          1. Previous exposure to pamrevlumab.&#xD;
&#xD;
          2. Evidence of significant obstructive lung disease, as evidenced by spirometry or HRCT.&#xD;
&#xD;
          3. Female participants who are pregnant or nursing.&#xD;
&#xD;
          4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the&#xD;
             study.&#xD;
&#xD;
          5. Interstitial lung disease other than IPF.&#xD;
&#xD;
          6. Sustained improvement in the severity of IPF during the 12 months prior to screening.&#xD;
&#xD;
          7. Other types of respiratory diseases that, in the opinion of the Investigator, would&#xD;
             impact the primary protocol endpoint or otherwise preclude participation in the study,&#xD;
             including diseases of the airways, lung parenchyma, pleural space, mediastinum,&#xD;
             diaphragm, or chest wall.&#xD;
&#xD;
          8. Certain medical conditions, that, in the opinion of the Investigator, would impact the&#xD;
             primary protocol endpoint or otherwise preclude participation in the study (such as,&#xD;
             myocardial infarction/stroke, severe chronic heart failure, pulmonary hypertension, or&#xD;
             cancers).&#xD;
&#xD;
          9. Acute IPF exacerbation during Screening or Randomization including hospitalization due&#xD;
             to acute IPF exacerbation within 4 weeks prior to or during screening.&#xD;
&#xD;
         10. Use of any investigational drugs or unapproved therapies, or participation in any&#xD;
             clinical trial with an investigational new drug within 30 days prior to screening. Or&#xD;
             use of approved IPF therapies (such as, pirfenidone or nintedanib) within 1 week prior&#xD;
             to screening.&#xD;
&#xD;
         11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine&#xD;
             monoclonal antibodies, or to any component of the excipient.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UAB Lung Health Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Jewish Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Francis Medical Center</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmonary Disease Specialists d/b/a PDS Research</name>
      <address>
        <city>Kissimmee</city>
        <state>Florida</state>
        <zip>34741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TGH/USF Center for Advanced Lung Disease and Lung Transplant</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University/The Emory Clinic</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The General Hospital Corporation d/b/a Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</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>PulmonIx, LLC</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Milton S Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Low Country Lung and Critical Care, PA</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Vermont</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Clinical Research</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Respirar - Centro Médico Dra. De Salvo</name>
      <address>
        <city>Ciudad Autonoma De Buenos Aires (CABA)</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clínicas da UFMG - Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - CPC HC/UFMG</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30130-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irmandade da Santa Casa de Misericórdia de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90020-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HSL-PUCRS Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Dia do Pulmão</name>
      <address>
        <city>Blumenau</city>
        <state>Santa Catarina</state>
        <zip>89030-101</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UPECLIN - UNESP</name>
      <address>
        <city>Botucatu</city>
        <state>São Paulo</state>
        <zip>18618-686</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEMEC - Centro Multidisciplinar de Estudos Clínicos LTDA EPP</name>
      <address>
        <city>Sao Bernardo do Campo</city>
        <state>São Paulo</state>
        <zip>09715-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CPQuali Pesquisa Clínica Ltda.</name>
      <address>
        <city>São Paulo</city>
        <zip>01228-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Alemao Oswaldo Cruz</name>
      <address>
        <city>São Paulo</city>
        <zip>01323-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INCOR - Instituto do Coração Centro de Pesquisa Prof. Dr. Fulvio Pileggi Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP</name>
      <address>
        <city>São Paulo</city>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BeiJing Chao-Yang Hospital,Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Frindship hosiptal capital Medical University</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Japan Friendship hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sichuan People's Hospital</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Oriental Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Tianjin Medical University</name>
      <address>
        <city>Tianjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Hospital Tongji Medical College Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xian</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Ningxia Medical University</name>
      <address>
        <city>Yinchuan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Santa Fe de Bogotá</name>
      <address>
        <city>Bogota</city>
        <zip>110121</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundación Neumológica Colombiana</name>
      <address>
        <city>Bogota</city>
        <zip>110131</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthy Medical Center S.A.S</name>
      <address>
        <city>Zipaquirá</city>
        <zip>250252</zip>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultní nemocnice Brno</name>
      <address>
        <city>Brno</city>
        <zip>625 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Jihlava</name>
      <address>
        <city>Jihlava</city>
        <zip>586 33</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nemocnice Na Bulovce, Klinika pneumologie</name>
      <address>
        <city>Prague</city>
        <zip>18081</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus Universitets Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>DK-8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Obstetricia y Ginecologia</name>
      <address>
        <city>Santo Domingo</city>
        <zip>10205</zip>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Medico Dominicano</name>
      <address>
        <city>Santo Domingo</city>
        <zip>456</zip>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Caen</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Memoire Ressources Recherche, Hopital F. MITTERRAND</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H.R.U. de Montpellier - Hôpital Lapeyronie</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nice Hôpital Pasteur</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Bichat - Claude Bernard</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Reims Hopital Maison Blanche</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rennes Hôpital Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service de Néphrologie, Hôpital Bretonneau, CHRU de Tours</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Institute Of Clinical Medicine Todua Clinic</name>
      <address>
        <city>Tbilisi</city>
        <zip>0112</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic Diacor</name>
      <address>
        <city>Tbilisi</city>
        <zip>0159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruhrlandklinik-Universitaetsmedizin Essen</name>
      <address>
        <city>Essen</city>
        <zip>45239</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik Schillerhoehe</name>
      <address>
        <city>Gerlingen</city>
        <zip>70839</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Agaplesion Evangelisches Krankenhaus Mittelhessen</name>
      <address>
        <city>Gießen</city>
        <zip>035398</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Munich</name>
      <address>
        <city>Munich</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>RoMed Klinikum Rosenheim</name>
      <address>
        <city>Rosenheim</city>
        <zip>83022</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut fur Pneumologie an der Universitat zu Koln</name>
      <address>
        <city>Solingen</city>
        <zip>83022</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis University Clinic of Pulmonology</name>
      <address>
        <city>Budapest</city>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orszagos Koranyi Tbc es Pulmonologiai Intezet, IV. Tudobelosztaly</name>
      <address>
        <city>Budapest</city>
        <zip>1121</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fejer Megyei Szent Gyorgy kh</name>
      <address>
        <city>Szekesfehervar</city>
        <zip>8000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmonology Hospital</name>
      <address>
        <city>Törökbálint</city>
        <zip>2045</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal College of Surgeons in Ireland</name>
      <address>
        <city>Dublin</city>
        <zip>D09YD60</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gaspare Rodiloco Hospital</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale G.B.Morgagni L.Pierantoni - Azienda Unita Sanitaria Locale (AUSL) di Forli</name>
      <address>
        <city>Forli</city>
        <zip>47121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Giuseppe</name>
      <address>
        <city>Milan</city>
        <zip>20123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Policlinico di Modena</name>
      <address>
        <city>Modena</city>
        <zip>41124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monaldi Hospital</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria di Padova</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Fondazione San Matteo di Pavia</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Agostina Gemelli University Polyclinic</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Senese, Policlinico &quot;Le Scotte&quot;</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Citta' della Salute e delle Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <zip>0126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria &quot;Ospedali Riuniti di Ancona&quot;</name>
      <address>
        <city>Torrette</city>
        <zip>60126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Myongji Hospital</name>
      <address>
        <city>Goyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>10475</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soonchunhyang University Hospital Bucheon</name>
      <address>
        <city>Bucheon-si</city>
        <zip>14584</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea Bucheon St. Mary's Hospital</name>
      <address>
        <city>Bucheon</city>
        <zip>14647</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Haeundae Paik Hospital</name>
      <address>
        <city>Busan</city>
        <zip>48108</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Hospital Iisan Paik Hospital</name>
      <address>
        <city>Goyang</city>
        <zip>10380</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hospital</name>
      <address>
        <city>Gwangju</city>
        <zip>61469</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Centre</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyunghee University Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>17104</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>3722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soonchunhyang University Hospital Seoul</name>
      <address>
        <city>Seoul</city>
        <zip>4401</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>5505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Yeouido ST. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>7345</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <zip>44033</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American University of beirut medical center</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hotel Dieu De France</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rafik Hariri University Hospital (Clinical Research Unit)</name>
      <address>
        <city>Bir Hassan</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Enfermedades Respiratorias INER</name>
      <address>
        <city>Mexico</city>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidad Medica para la Salud Integral (UMSI)</name>
      <address>
        <city>Mexico</city>
        <zip>66465</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Care and Research S.A. de C.V.</name>
      <address>
        <city>Mexico</city>
        <zip>97070</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Lucas Clinical Research Center SA de CV</name>
      <address>
        <city>Mexico</city>
        <zip>CP97217</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Regional para el estudio del Adulto Mayor, Servicio de Geriatria, Hospital Universitario Dr Jose Eleuterio Gonzalez</name>
      <address>
        <city>Monterrey</city>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oaxaca Site Management Organization S.C. (OSMO)</name>
      <address>
        <city>Oaxaca</city>
        <zip>68000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept. of Pulmonary Diseases</name>
      <address>
        <city>Amsterdam</city>
        <zip>30.033</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catharina Hospital</name>
      <address>
        <city>Eindhoven</city>
        <zip>5623 EJ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Longarts - Opleider Longziekten Zuyderland MC</name>
      <address>
        <city>Heerlen</city>
        <zip>6419</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis BV</name>
      <address>
        <city>Nieuwegein</city>
        <zip>3435</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Canisius-Wilhelmina Ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <zip>6533</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Internacional</name>
      <address>
        <city>Lima</city>
        <zip>15001</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica San Pablo</name>
      <address>
        <city>Lima</city>
        <zip>150140</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Providencia</name>
      <address>
        <city>Lima</city>
        <zip>15088</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Nacional Cayetano Heredia / Servicio de Inmunología y Reumatología</name>
      <address>
        <city>Lima</city>
        <zip>15102</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigacion Ricardo Palma</name>
      <address>
        <city>San Isidro</city>
        <zip>150131</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica La luz</name>
      <address>
        <city>Santa Beatriz</city>
        <zip>15046</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz</name>
      <address>
        <city>Bedzin</city>
        <zip>42-500</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Medycyny Oddechowej Mroz SJ</name>
      <address>
        <city>Bialystok</city>
        <zip>15-044</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach</name>
      <address>
        <city>Katowice</city>
        <zip>40-635</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital No1</name>
      <address>
        <city>Lodz</city>
        <zip>90-153</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instytut Gruzlicy i Chorob Pluc</name>
      <address>
        <city>Warsaw</city>
        <zip>01-138</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institute for Lung Diseases and Tuberculosis</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Center of Serbia</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Center of Nis</name>
      <address>
        <city>Nis</city>
        <zip>18000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Pulmonary Diseases of Vojvodina</name>
      <address>
        <city>Sremska Kamenica</city>
        <zip>21204</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>8036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitaio de La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Maranon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos-Madrid C/Martin Lagos s/n</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Quironsalud Madrid</name>
      <address>
        <city>Madrid</city>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marques de Valdecilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Nuestra Senora de Valme</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinik für Pneumologie</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal non-profit enterprise &quot;City clinical hospital #16&quot; of Dnipro Сit Сouncil</name>
      <address>
        <city>Dnipro</city>
        <zip>49069</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivano-Frankivsk Regional Phthisiology-Pulmonology Center of Ivano-Frankivsk regional council</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute of Phthisiology and Pulmonology named after F. G. Yanovskyi NAMS of Ukraine, Clinical and Functional Department</name>
      <address>
        <city>Kyiv</city>
        <zip>03680</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medway NHS Foundation Trust</name>
      <address>
        <city>Gillingham</city>
        <state>Kent</state>
        <zip>ME7 5NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Papworth Hospital NHS Foundation Trust, Advanced Heart Failure Unit</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0AY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Princess Alexandra Hospital NHS Trust</name>
      <address>
        <city>Harlow</city>
        <zip>CM20 1QX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brompton Hospital</name>
      <address>
        <city>London</city>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London</name>
      <address>
        <city>London</city>
        <zip>WC1E 6JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manchester University NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southampton General Hospital</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>China</country>
    <country>Colombia</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Dominican Republic</country>
    <country>France</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Lebanon</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Peru</country>
    <country>Poland</country>
    <country>Serbia</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>April 17, 2023</last_update_submitted>
  <last_update_submitted_qc>April 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Idiopathic Pulmonary Fibrosis</keyword>
  <keyword>IPF</keyword>
  <keyword>Idiopathic Interstitial Pneumonia</keyword>
  <keyword>Interstitial Lung Disease</keyword>
  <keyword>Lung Fibrosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04419558
org study id: FGCL-3019-095
nct id: NCT04419558
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram
      (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to
      placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week
      randomized treatment phase followed by an optional, open-label extension phase.
The intent of this study is to evaluate the efficacy and safety of pamrevlumab as monotherapy
      in participants with IPF. Participants who are not being treated with approved IPF therapies
      (that is, nintedanib or pirfenidone) may be eligible for screening. Examples of reasons
      participants may not be treated with approved IPF therapies include but are not limited to:

        -  Intolerant or not responsive to approved IPF therapies

        -  Ineligible to receive these therapies

        -  Participant voluntarily declines to receive approved IPF therapies after being fully
           informed of the potential benefits/risks

      NOTE: No participant should discontinue an approved IPF therapy for the purpose of enrolling
      in this study.

      During the 48-week treatment phase of the study, co-administration of an approved IPF therapy
      (such as, pirfenidone or nintedanib) is acceptable if clinically indicated in the
      Investigator's opinion, after assessment of potential risks/benefits of such combination with
      blinded study treatment.

      Participants who complete the 48-week study will be eligible for an optional, open-label
      extension phase with continued access to pamrevlumab, regardless of their randomized
      assignment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: During the Open-label extension phase, all participants will receive pamrevlumab in an open-label manner. No unblinding of participant's treatment assignment in the treatment phase (main study) will occur for purposes of open-label extension participation.
measure: Change From Baseline in Forced Vital Capacity (FVC) at Week 48
time frame: Baseline, Week 48
measure: Time to Disease Progression
time frame: Up to Week 48
description: Defined as absolute FVC percent predicted (FVCpp) decline of ≥10% or death, whichever occurs first
measure: Change from Baseline to Week 48 in Quantitative Lung Fibrosis (QLF) Volume
time frame: Baseline, Week 48
measure: Time to Any Component of the Clinical Composite Endpoint, Whichever Occurs First: Acute IPF Exacerbation, Respiratory Hospitalization, or Death
time frame: Up to Week 48
measure: Time to First Acute IPF Exacerbation
time frame: Up to Week 48
measure: Time to All-Cause Mortality
time frame: Up to Week 48
measure: Time to First Respiratory Hospitalization
time frame: Up to Week 48
arm group label: Pamrevlumab
arm group type: Experimental
description: Treatment phase: Pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks.
Open-label extension phase: Pamrevlumab 30 mg/kg administered by intravenous infusion, every 3 weeks for up to 48 weeks
arm group label: Placebo
arm group type: Experimental
description: Pamrevlumab-matching placebo administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks
intervention type: Drug
intervention name: Pamrevlumab
description: Sterile solution for injection
arm group label: Pamrevlumab
other name: FG-3019
intervention type: Drug
intervention name: Placebo
description: Sterile solution for injection
arm group label: Placebo
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
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country: Argentina
country: Brazil
country: China
country: Colombia
country: Czechia
country: Denmark
country: Dominican Republic
country: France
country: Georgia
country: Germany
country: Hungary
country: Ireland
country: Italy
country: Korea, Republic of
country: Lebanon
country: Mexico
country: Netherlands
country: Peru
country: Poland
country: Serbia
country: Spain
country: Switzerland
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Fibrosis