<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/NCT04456998</url>
  </required_header>
  <id_info>
    <org_study_id>GB002-2101</org_study_id>
    <nct_id>NCT04456998</nct_id>
  </id_info>
  <brief_title>GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)</brief_title>
  <official_title>A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Study to Evaluate the Efficacy and Safety of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gossamer Bio Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective for this trial is to determine the effect of GB002 (seralutinib) on&#xD;
      improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH&#xD;
      who are Functional Class (FC) II and III. The secondary objective for this trial is to&#xD;
      determine the effect of GB002 (seralutinib) on improving exercise capacity in this&#xD;
      population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2020</start_date>
  <completion_date type="Actual">November 1, 2022</completion_date>
  <primary_completion_date type="Actual">October 17, 2022</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>Double (Participant, Investigator)</masking>
    <masking_description>Subjects, investigators, other site personnel, and Sponsor (and/or designee) personnel who are directly involved in the conduct of the study, collection of the data, and analysis of the final safety and efficacy results will remain blinded to treatment assignments until after the completion of the study and the database has been locked.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline to Week 24 in Pulmonary Vascular Resistance (PVR)</measure>
    <time_frame>Baseline, 24 weeks</time_frame>
    <description>Change in PVR using right heart catheterization (RHC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline to Week 24 on the Six-Minute Walk Test (6MWT)</measure>
    <time_frame>Baseline, 24 weeks</time_frame>
    <description>Change in distance achieved on the 6MWT (Δ6MWD)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Pulmonary Artery Hypertension</condition>
  <arm_group>
    <arm_group_label>GB002 (seralutinib)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GB002 (seralutinib) inhaled orally twice per day (BID) over 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo inhaled orally BID over 24 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GB002 (seralutinib)</intervention_name>
    <description>Capsule containing GB002 (seralutinib)</description>
    <arm_group_label>GB002 (seralutinib)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching capsule containing placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Generic Dry Powder Inhaler</intervention_name>
    <description>Generic dry powder inhaler for GB002 (seralutinib) or placebo delivery</description>
    <arm_group_label>GB002 (seralutinib)</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A current diagnosis of symptomatic PAH classified by one of the following:&#xD;
&#xD;
               1. Idiopathic PAH (IPAH) or heritable pulmonary arterial hypertension (HPAH).&#xD;
&#xD;
               2. PAH associated with connective tissue disease (CTD-APAH).&#xD;
&#xD;
               3. PAH associated with anorexigen or methamphetamine use.&#xD;
&#xD;
               4. Congenital heart disease with simple systemic to pulmonary shunt at least 1 year&#xD;
                  after surgical repair.&#xD;
&#xD;
          2. 6MWD ≥ 150 meters and ≤ 550 meters at screening.&#xD;
&#xD;
          3. WHO FC II or III symptomatology.&#xD;
&#xD;
          4. Treatment with standard of care PAH background therapies.&#xD;
&#xD;
          5. Documentation of cardiac catheterization within the screening period that is&#xD;
             consistent with the diagnosis of PAH and meeting all the following criteria, to be&#xD;
             confirmed by a central hemodynamic core laboratory:&#xD;
&#xD;
               1. Mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg (at rest), AND&#xD;
&#xD;
               2. PVR ≥ 400 dyne•sec/cm5, AND&#xD;
&#xD;
               3. Pulmonary capillary wedge pressure (PCWP) or left ventricular-end diastolic&#xD;
                  pressure (LVEDP) ≤12 mm Hg if PVR ≥400 to &lt;500 dyne∙sec/cm5 OR&#xD;
&#xD;
               4. PCWP or LVEDP ≤15 mmHg if PVR ≥500 dyne∙sec/cm5&#xD;
&#xD;
          6. Pulmonary function tests (PFTs) at screening with the following criteria met:&#xD;
&#xD;
               1. Forced expiratory volume in 1 second (FEV1) divided by the forced vital capacity&#xD;
                  (FVC) ≥70%;&#xD;
&#xD;
               2. Total lung capacity (TLC) or FVC ≥ 70% predicted&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of chronic thromboembolic disease or acute pulmonary embolism as assessed by&#xD;
             ventilation-perfusion (V/Q) scan, computed tomography (CT)-angiogram, or pulmonary&#xD;
             angiogram prior to screening.&#xD;
&#xD;
          2. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure &gt;&#xD;
             160 mm Hg or sitting diastolic blood pressure &gt; 100 mm Hg during screening visit after&#xD;
             a period of rest.&#xD;
&#xD;
          3. Systolic blood pressure &lt; 90 mm Hg during screening and baseline visits.&#xD;
&#xD;
          4. WHO Pulmonary Hypertension Group 2-5.&#xD;
&#xD;
          5. Human immunodeficiency virus (HIV)-associated PAH.&#xD;
&#xD;
          6. History of left-sided heart disease and/or clinically significant cardiac disease.&#xD;
&#xD;
          7. Untreated severe obstructive sleep apnea.&#xD;
&#xD;
          8. History of atrial septostomy within 180 days prior to screening.&#xD;
&#xD;
          9. Pulmonary venous occlusive disease (PVOD).&#xD;
&#xD;
         10. Subjects with a history of portopulmonary hypertension or portal hypertension due to&#xD;
             cirrhosis classified as Child-Pugh Class A or higher; or baseline ALT or AST &gt; 2 x ULN&#xD;
             or Total Bilirubin ≥ 2 x ULN.&#xD;
&#xD;
         11. History of malignancy within 5 years prior to screening.&#xD;
&#xD;
         12. History of a potentially life-threatening cardiac arrhythmia with an ongoing risk.&#xD;
&#xD;
         13. Severe acute or chronic medical or laboratory abnormality that may increase the risk&#xD;
             associated with study participation or IP administration (eg; history intracranial&#xD;
             hemorrhage).&#xD;
&#xD;
         14. Chronic renal insufficiency as defined by an estimated glomerular filtration rate&#xD;
             (eGFR) &lt; 45 mL/min/1.73m2 via Chronic Kidney Disease Epidemiology Collaboration&#xD;
             (CKD-epi) at screening or requires dialytic therapy or hemofiltration.&#xD;
&#xD;
         15. Hemoglobin (Hgb) concentration &lt; 8.5 g/dL at screening.&#xD;
&#xD;
         16. Evidence of active HIV, Hepatitis B or Hepatitis C, or tuberculosis (TB) infections.&#xD;
&#xD;
         17. Inhaled prostanoids; these drugs may be withdrawn ≥ 4 weeks prior to or at screening,&#xD;
             if clinically indicated.&#xD;
&#xD;
         18. Use of oral anticoagulants (ie, warfarin or NOAC) at randomization.&#xD;
&#xD;
         19. Requirement of intravenous (IV) inotropes (ie, levosimendan, dopamine, dobutamine,&#xD;
             milrinone, norepinephrine) other than an IV prostanoid within 4 weeks of screening.&#xD;
&#xD;
         20. Prior participation in GB002 studies and/or prior treatment with GB002.&#xD;
&#xD;
         21. Currently participating in or has participated in a study of an investigational agent&#xD;
             or has used an investigational device for the treatment of PAH within 4 weeks prior to&#xD;
             screening.&#xD;
&#xD;
         22. Current use of inhaled tobacco and/or inhaled marijuana.&#xD;
&#xD;
         23. Current alcohol use disorder as defined by DSM-5 and/or positive test for drugs of&#xD;
             abuse (amphetamines, methamphetamines, cocaine, phencyclidine [PCP]).&#xD;
&#xD;
         24. Subjects with a history of severe milk protein allergy. In addition, subjects with&#xD;
             known intolerance or hypersensitivity to lactose who, in the opinion of the&#xD;
             investigator, may experience severe symptoms following the ingestion of lactose.&#xD;
&#xD;
         25. QTcF of &gt; 480 msec recorded on a screening or baseline ECG or receiving concurrent&#xD;
             treatment with medications that prolong QT interval.&#xD;
&#xD;
         26. Have any other condition or reason that, in the opinion of the Investigator or Medical&#xD;
             Monitor, would prohibit the subject from participating in the study.&#xD;
&#xD;
        NOTE: Additional inclusion/exclusion criteria may apply, per protocol.&#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>Richard Aranda</last_name>
    <role>Study Director</role>
    <affiliation>Gossamer Bio Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pulmonary Associates, PA</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dept of Veterans Affairs Greater Los Angeles Healthcare System</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 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>Medical Corporation</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Healthcare</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Florida Pulmonary Group, PA</name>
      <address>
        <city>Altamonte Springs</city>
        <state>Florida</state>
        <zip>32701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Florida</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Emory Clinic</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals &amp; Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>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>Kentuckiana Pulmonary Research Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</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>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>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico Health Sciences Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian Hospital - Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INTEGRIS Baptist Medical Center, Inc.</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</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>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Health</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin - Froedtert Hospital</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital</name>
      <address>
        <city>Darlinghurst</city>
        <state>New South Wales</state>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Melbourne</name>
      <address>
        <city>Fitzroy</city>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Hobart Hospital</name>
      <address>
        <city>Hobart</city>
        <zip>TAS 7000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Westmead</city>
        <zip>NSW 2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH - Univ. Klinikum Graz - Universitatsklinik fur Innere Medizin</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitat Wien - Universitatsklinik fur Innere Medizin II</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasme University Hospital</name>
      <address>
        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Mortimer B Davis Jewish General Hospital</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peter Lougheed Centre</name>
      <address>
        <city>Calgary</city>
        <zip>T1Y 6J4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre - Victoria Hospital</name>
      <address>
        <city>London</city>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Všeobecná fakultní nemocnice v Praze</name>
      <address>
        <city>Praha</city>
        <zip>128 08</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HP, Hopital de Bicetre</name>
      <address>
        <city>Le Kremlin-Bicetre</city>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier - Hopital Arnaud de Villeneuve</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz- und Diabeteszentrum NRW</name>
      <address>
        <city>Bad Oeynhausen</city>
        <zip>32545</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DRK Kliniken Berlin - Westend</name>
      <address>
        <city>Berlin</city>
        <zip>14050</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Giessen / Marburg</name>
      <address>
        <city>Gießen</city>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentrum fur Pulmonale Hypertonie Thoraxklinik-Heidelberg gGmbH</name>
      <address>
        <city>Heidelberg</city>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Regensburg</name>
      <address>
        <city>Regensburg</city>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Centre of Serbia</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</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 Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marqués de Valdecilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Papworth Hospital NHS Foundation</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0AY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust - Hammersmith Medicines Research Limited</name>
      <address>
        <city>London</city>
        <zip>W12 OHS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Serbia</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Israel</country>
  </removed_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>seralutinib</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Arterial Hypertension</mesh_term>
    <mesh_term>Hypertension</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/NCT04456998
org study id: GB002-2101
nct id: NCT04456998
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
The primary objective for this trial is to determine the effect of GB002 (seralutinib) on
      improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH
      who are Functional Class (FC) II and III. The secondary objective for this trial is to
      determine the effect of GB002 (seralutinib) on improving exercise capacity in this
      population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Subjects, investigators, other site personnel, and Sponsor (and/or designee) personnel who are directly involved in the conduct of the study, collection of the data, and analysis of the final safety and efficacy results will remain blinded to treatment assignments until after the completion of the study and the database has been locked.
measure: Change from Baseline to Week 24 in Pulmonary Vascular Resistance (PVR)
time frame: Baseline, 24 weeks
description: Change in PVR using right heart catheterization (RHC)
measure: Change From Baseline to Week 24 on the Six-Minute Walk Test (6MWT)
time frame: Baseline, 24 weeks
description: Change in distance achieved on the 6MWT (Δ6MWD)
arm group label: GB002 (seralutinib)
arm group type: Experimental
description: GB002 (seralutinib) inhaled orally twice per day (BID) over 24 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo inhaled orally BID over 24 weeks
intervention type: Drug
intervention name: GB002 (seralutinib)
description: Capsule containing GB002 (seralutinib)
arm group label: GB002 (seralutinib)
intervention type: Drug
intervention name: Placebo
description: Matching capsule containing placebo
arm group label: Placebo
intervention type: Device
intervention name: Generic Dry Powder Inhaler
description: Generic dry powder inhaler for GB002 (seralutinib) or placebo delivery
arm group label: GB002 (seralutinib)
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Richard Aranda
role: Study Director
affiliation: Gossamer Bio Inc.
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country: Australia
country: Austria
country: Belgium
country: Canada
country: Czechia
country: France
country: Germany
country: Serbia
country: Spain
country: United Kingdom
country: United States
country: Israel
responsible party type: Sponsor
mesh term: Pulmonary Arterial Hypertension
mesh term: Hypertension
sharing ipd: No