<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/NCT03832946</url>
  </required_header>
  <id_info>
    <org_study_id>GALACTIC-1</org_study_id>
    <secondary_id>2018-002664-73</secondary_id>
    <nct_id>NCT03832946</nct_id>
  </id_info>
  <brief_title>A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)</brief_title>
  <official_title>GALACTIC-1 -A Randomized, Double-blind, Multicentre, Parallel, Placebo-controlled Phase 2b Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Investigating the Efficacy and Safety of GB0139, an Inhaled Galectin-3 Inhibitor Administered Via a Dry Powder Inhaler Over 52 Weeks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Galecto Biotech AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Syneos Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>bioRASI, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Galecto Biotech AB</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 randomized, double-blind, placebo-controlled phase 2b trial in subjects with IPF&#xD;
      (idiopathic pulmonary fibrosis) investigating the efficacy and safety of GB0139.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to evaluate the efficacy and safety of GB0139, a galectin-3 inhibitor,&#xD;
      administered by dry powder inhalation over 52 weeks. GB0139, given once per day, will be&#xD;
      compared to placebo. GB0139 was previously known as TD139.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 19, 2019</start_date>
  <completion_date type="Actual">May 17, 2023</completion_date>
  <primary_completion_date type="Actual">May 17, 2023</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>
    <intervention_model_description>All subjects eligible for the study will be randomised into one of the two treatment arms:&#xD;
A. GB0139 3 mg once a day B. Placebo once a day</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>This study is a double-blind study. The blinding will be maintained throughout the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Annual rate of decline in Forced Vital Capacity (FVC)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Efficacy of GB0139 as measured by the annual rate of decline in FVC expressed in mL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute decline in FVC &gt;10%</measure>
    <time_frame>52 weeks</time_frame>
    <description>Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of &gt; 10%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first hospitalization</measure>
    <time_frame>52 weeks</time_frame>
    <description>Time to first hospitalization (respiratory related, including acute exacerbation of IPF) expressed in days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to death</measure>
    <time_frame>52 weeks</time_frame>
    <description>Time to death from all-causes, respiratory-related causes and/or caused by IPF expressed in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Respiratory Related Quality of Life using the St. George's Respiratory Questionnaire (SGRQ)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Change from baseline in the SGRQ total score. The SGRQ is a 50-item questionnaire split into three domains: symptoms, activity and impact. Weighting of both individual domains and the total score produces a range from 0 to 100, with higher scores indicating a poorer health-related quality of life.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Absolute decline in FVC &gt;5%</measure>
    <time_frame>52 weeks</time_frame>
    <description>Percentage of subjects with an absolute decline from baseline in FVC (% predicted) of &gt; 5%</description>
  </other_outcome>
  <other_outcome>
    <measure>6-minute walk test (6MWT) distance</measure>
    <time_frame>52 weeks</time_frame>
    <description>Change from baseline in distance walked (metres) over 6 minutes</description>
  </other_outcome>
  <other_outcome>
    <measure>Diffusion capacity of the lung for carbon monoxide (DLCO)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Change from baseline in DLCO, corrected for Hemaglobin (mmol/min/kPa)</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of Dyspnea using the University of California San Diego - Shortness of Breath Questionnaire (UCSD - SOBQ)</measure>
    <time_frame>Weeks 12, 26 and 52</time_frame>
    <description>Change from baseline in UCSD - SOBQ Scored from 0-120 where a higher score indicates worse dyspnea</description>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of Health Related Quality of Life (HRQoL) using the Short-Form 36-Item Health Survey (SF-36)</measure>
    <time_frame>Weeks 12, 26 and 52</time_frame>
    <description>The Medical Outcomes SF-36 It is a self-administered questionnaire of 36-items measuring eight dimensions of general HRQoL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively. A higher score indicates a more favourable state of health</description>
  </other_outcome>
  <other_outcome>
    <measure>Frequency of Adverse Events (AE) or Serious Adverse Events (SAE)</measure>
    <time_frame>52 weeks</time_frame>
    <description>Percentage of subjects with Adverse Events (AE) or Serious Adverse Events (SAE)</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to hospitalization</measure>
    <time_frame>52 weeks</time_frame>
    <description>Time in days to first hospitalization from all causes</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to hospitalization</measure>
    <time_frame>52 weeks</time_frame>
    <description>Time in days to first hospitalization (IPF related, including acute exacerbation of IPF)</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to respiratory related death</measure>
    <time_frame>52 weeks</time_frame>
    <description>Time in days to death from respiratory related causes (including IPF)</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to initiation of pirfenidone or nintedanib treatment</measure>
    <time_frame>52 weeks</time_frame>
    <description>Time in days to initiation of pirfenidone or nintedanib treatment in subjects not treated with pirfenidone or nintedanib at time of enrolment</description>
  </other_outcome>
  <other_outcome>
    <measure>Annual rate of decline in FVC in subjects never treated with pirfenidone or nintedanib</measure>
    <time_frame>52 weeks</time_frame>
    <description>Change in FVC expressed in mL for subjects who have never been treated with pirfenidone or nintedanib</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">426</enrollment>
  <condition>Idiopathic Pulmonary Fibrosis (IPF)</condition>
  <arm_group>
    <arm_group_label>A. GB0139 3 mg once a day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inhalation of GB0139</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B. Placebo once a day</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Inhalation of Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GB0139</intervention_name>
    <description>GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.</description>
    <arm_group_label>A. GB0139 3 mg once a day</arm_group_label>
    <other_name>TD139</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo is administered as inhalation once a day</description>
    <arm_group_label>B. Placebo once a day</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects aged ≥ 40 years of age with a diagnosis of IPF established&#xD;
             during the previous five years according to ATS/ERS/Fleischner criteria.&#xD;
&#xD;
          2. Lung function parameters as follows:&#xD;
&#xD;
               1. Forced Vital Capacity (FVC) &gt; 45% of the predicted value at screening&#xD;
&#xD;
               2. Diffusion lung capacity for carbon monoxide (DLCO) (corrected for Hb) of 30% to&#xD;
                  79% of the predicted value at screening&#xD;
&#xD;
          3. Subjects who currently are not being treated with nintedanib or pirfenidone; or cannot&#xD;
             tolerate nintedanib or pirfenidone&#xD;
&#xD;
          4. Subjects must sign and date a written, IRB/EC approved informed consent form and any&#xD;
             required authorization prior to initiation of any study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently has significant airways obstruction: Forced Expiratory Volume in 1 s&#xD;
             (FEV1)/Forced Vital Capacity (FVC) ratio of &lt; 0.7 at screening.&#xD;
&#xD;
          2. Has clinical evidence of active infection, including, but not limited to, bronchitis,&#xD;
             pneumonia, sinusitis, urinary tract infection, and cellulitis.&#xD;
&#xD;
          3. Has a history of malignancy within the last 2 years with the exception of basal cell&#xD;
             carcinoma, chronic lymphocytic leukaemia (under observation) and prostate cancer&#xD;
             requiring anti-androgens, localised treatment (minor surgery, radiotherapy) and/or&#xD;
             managed by observation.&#xD;
&#xD;
          4. Has any condition other than IPF that, in the opinion of the investigator, is likely&#xD;
             to result in the death of the subject within the next 2 years.&#xD;
&#xD;
          5. Presence of other disease that may interfere with testing procedures or in the&#xD;
             judgement of the Investigator may interfere with trial participation or may put the&#xD;
             patient at risk when participating in this trial.&#xD;
&#xD;
          6. Is likely to receive lung transplantation within the next 12 months.&#xD;
&#xD;
          7. Currently receiving nintedanib, pirfenidone, high dose corticosteroid, cytotoxic&#xD;
             (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), vasodilator&#xD;
             therapy for pulmonary hypertension (e.g., bosentan). A current dose of less than or&#xD;
             equal to 15 mg/day of prednisone or its equivalent is acceptable if the dose is&#xD;
             anticipated to remain stable during the study.&#xD;
&#xD;
          8. Prior use of GB0139 (also called TD139) or previously randomized in GALACTIC-1.&#xD;
&#xD;
          9. Prior use of nintedanib or pirfenidone within 7 days of initiation of screening.&#xD;
&#xD;
         10. Prior use of investigational drugs within 30 days (or 5 half-lives, whichever is&#xD;
             longer) of initiation of screening.&#xD;
&#xD;
         11. Participating in another clinical trial, either interventional or observational.&#xD;
&#xD;
         12. Has a history of unstable or deteriorating cardiac or pulmonary disease (other than&#xD;
             IPF) within the previous six months, including, but not limited to, the following:&#xD;
&#xD;
               1. Unstable angina pectoris or myocardial infarction, or percutaneous coronary&#xD;
                  intervention within the last 6 months&#xD;
&#xD;
               2. Congestive heart failure requiring hospitalization&#xD;
&#xD;
               3. Uncontrolled clinically significant arrhythmias&#xD;
&#xD;
         13. If female, the subject is pregnant or lactating or intending to become pregnant before&#xD;
             participating in this study during the study and within (5 half- lives plus 30 days)&#xD;
             after last dose of the study drug; or intending to donate ova during such time period.&#xD;
&#xD;
         14. Woman considered to be of childbearing potential who do not use highly effective birth&#xD;
             control methods during the study.&#xD;
&#xD;
         15. Hypersensitivity to the active substance (TD139/GB0139) or the excipient (lactose).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Toby Maher, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Keck Medicine of USC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SEC Clinical Research</name>
      <address>
        <city>Andalusia</city>
        <state>Alabama</state>
        <zip>36420-5310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jasper Summit Research, LLC Pulmonary &amp; Sleep Associates</name>
      <address>
        <city>Jasper</city>
        <state>Alabama</state>
        <zip>35501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palmtree Clinical Research Inc</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262-4871</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paradigm Research</name>
      <address>
        <city>Redding</city>
        <state>California</state>
        <zip>96001-0172</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520-8057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Shands Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harmony Medical Research Institute, Inc</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research for Health Improvement</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Broward Research Centre</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avanza Medical Research Centre</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Pulmonary Critical Care PLC</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital/Uni Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Healthcare Pulmonary and Critical Care Research</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</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>DC Research Works</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060-7297</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Memorial Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>97232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LaPorte County Institute for Clinical Research</name>
      <address>
        <city>Michigan City</city>
        <state>Indiana</state>
        <zip>46360-9330</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Centre</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harvard Medical School - Brigham and Womens Hospital (BWH)</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Lung Research Center LLC</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03766</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmonlx LLC</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45276</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232-2650</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Centre at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Sciences Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostics Research Group</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Health Scieces Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TPMG Clinical Research</name>
      <address>
        <city>Williamsburg</city>
        <state>Virginia</state>
        <zip>23188</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lung Research QLD</name>
      <address>
        <city>Chermside</city>
        <state>Queensland</state>
        <zip>4032</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flinders Medical Centre</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Respiratory Clinical Trials</name>
      <address>
        <city>Kent Town</city>
        <state>South Australia</state>
        <zip>5067</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Respiratory Health 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>TrialsWest</name>
      <address>
        <city>Spearwood</city>
        <state>Western Australia</state>
        <zip>6163</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires St-Luc</name>
      <address>
        <city>Louvain-la-Neuve</city>
        <state>Wallon Region</state>
        <zip>1348</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Antwerp</name>
      <address>
        <city>Antwerp</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CUB Hopital Erasme</name>
      <address>
        <city>Brussels</city>
        <zip>1400</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven- Campus Gasthuisberg</name>
      <address>
        <city>Brussels</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU UCL Namur site Godinne</name>
      <address>
        <city>Namur</city>
        <zip>5000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Firestone Institute for Respiratory Health</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 4A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Anees Medicine Professional Corporation</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8X 1T3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Dhar Medical Practice</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8X 5A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto General Hosp Research Inst</name>
      <address>
        <city>Toronto</city>
        <zip>M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier Hopitaux Universitaires Paris-Seine-Saint-Denis-Hopital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Lille - Hopital Calmette</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Nord de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP - Hopital Europen Georges-Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Bichat</name>
      <address>
        <city>Paris</city>
        <zip>75877</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Rennes Hopital Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de la Réunion Site SUD (Terre Sainte)</name>
      <address>
        <city>Saint Pierre</city>
        <zip>97410</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de la Réunion- Site Félix Guyon</name>
      <address>
        <city>Saint-Pierre</city>
        <zip>97410</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaires de Strasborg Service de Pneumologie Nouvel Hopital Civil</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Rgional et Universitaire - Hopital Bretonneau</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chapidze Emergency Cardiology Center</name>
      <address>
        <city>Tbilisi</city>
        <zip>0159</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Medical Center</name>
      <address>
        <city>Tbilisi</city>
        <zip>0180</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thoraxklinik-Heidelberg gGmbH</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden-Württemberg</state>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lungenfachklinik Immenhausen Department for Clinical Studies</name>
      <address>
        <city>Immenhausen</city>
        <state>Hessen</state>
        <zip>34376</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZMS Zentrum für medizinische Studien GmbH</name>
      <address>
        <city>Warendorf</city>
        <state>Rhine-Westphalia</state>
        <zip>48231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klifeck GmbH Praxis Med. Gerald Eckhardt</name>
      <address>
        <city>Delitzsch</city>
        <state>Sachsen</state>
        <zip>04509</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Studienzentrum Dr.med Falk Brunner FA fuer Innere Medizin und Pneumologie</name>
      <address>
        <city>Leipzig</city>
        <state>Saxony</state>
        <zip>04157</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIMS Studienzentrum Bamberg GmbH</name>
      <address>
        <city>Bamberg</city>
        <zip>96049</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Donaustauf</name>
      <address>
        <city>Donaustauf</city>
        <zip>93093</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruhrlandklinik Essen</name>
      <address>
        <city>Essen</city>
        <zip>45239</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Leipzig Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie, P</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>POIS Leipzig GbR</name>
      <address>
        <city>Leipzig</city>
        <zip>04357</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Grossadern der Ludwig-Maximilians-Universitaet Muenchen</name>
      <address>
        <city>Munich</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Centre for Health Sciences</name>
      <address>
        <city>Dublin</city>
        <zip>D24NROA</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kefar Sava</city>
        <zip>44281</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmonary Institute Rabin Medical Center</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4941492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaplan Medical Center</name>
      <address>
        <city>Reẖovot</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University-Hospital Policlinico Vittorio Emanuele</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milan</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Giuseppe Clinica Malattie dell Apparato Respiratorio</name>
      <address>
        <city>MIlan</city>
        <zip>20123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Mondena-AOU - Policlinico di Modena</name>
      <address>
        <city>Modena</city>
        <zip>41124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. Dei Colli OSPEDALE MONALDI</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale GB Morgagni</name>
      <address>
        <city>Padova</city>
        <zip>35100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Senese</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Città della Salute e della Scienza, PO Molinette</name>
      <address>
        <city>Turin</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi</name>
      <address>
        <city>Łódź</city>
        <state>Lodz</state>
        <zip>90-153</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instytut Gruzlicy i Chorob Pluc, I Klinika Chorob Pluc</name>
      <address>
        <city>Warszawa</city>
        <state>Mazovia</state>
        <zip>01-138</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oddział Kliniczny Pulmonologii i Alergologii Szpitala Uniwersyteckiego w Krakowie</name>
      <address>
        <city>Kraków</city>
        <state>Małopolskie</state>
        <zip>30688</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Alergologii Pneumonologii</name>
      <address>
        <city>Gdańsk</city>
        <state>Pomerania</state>
        <zip>80-214</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu</name>
      <address>
        <city>Poznań</city>
        <zip>60-569</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ. Marques de Valdecilla</name>
      <address>
        <city>Santander</city>
        <state>Cantabria</state>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Lucas Augusti</name>
      <address>
        <city>Lugo</city>
        <state>Galicia</state>
        <zip>27003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Quiron Madrid</name>
      <address>
        <city>Pozuelo De Alarcón</city>
        <state>Madrid</state>
        <zip>28223</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinica Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de Bellvitge</name>
      <address>
        <city>Barcelona</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>8035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chernivtsi Regional Clinical Hospital</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovsky</name>
      <address>
        <city>Kyiv</city>
        <zip>03038</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Research Centre for Radiation Medicine of The National Academy of Medical Sciences of UKR</name>
      <address>
        <city>Kyiv</city>
        <zip>03115</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ternopil Municipal City Hosipital 2</name>
      <address>
        <city>Ternopil</city>
        <zip>46023</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Centre Pulse</name>
      <address>
        <city>Vinnytsya</city>
        <zip>21001</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Papworth Hospital NHS Foundation Trust</name>
      <address>
        <city>Cambridge</city>
        <state>Cambridgeshire</state>
        <zip>CB2 0AY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Devon and Exeter Hospital</name>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brompton Hospital</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wythenshawe Hospital</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton NHS Foundation Trust</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glenfield Hospital</name>
      <address>
        <city>Leicester</city>
        <state>Leicestershire</state>
        <zip>LE3 9QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aintree Unversity Hospital NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L9 7AL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle Royal Victoria Infirmary</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <state>Newcastle</state>
        <zip>NE1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham City Hospital</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital (RHH)</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S5 7AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Heartlands Hospital</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Centre - Respiratory North Bristol NHS Trust Southmead Hospital</name>
      <address>
        <city>Bristol</city>
        <zip>BS10 5NB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Infirmary of Edinburgh</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH16 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>May 24, 2023</last_update_submitted>
  <last_update_submitted_qc>May 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TD139</keyword>
  <keyword>Idiopathic pulmonary fibrosis</keyword>
  <keyword>Galectin-3 inhibitor</keyword>
  <keyword>GB0139</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/NCT03832946
org study id: GALACTIC-1
secondary id: 2018-002664-73
nct id: NCT03832946
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-blind, placebo-controlled phase 2b trial in subjects with IPF
      (idiopathic pulmonary fibrosis) investigating the efficacy and safety of GB0139.
This study is designed to evaluate the efficacy and safety of GB0139, a galectin-3 inhibitor,
      administered by dry powder inhalation over 52 weeks. GB0139, given once per day, will be
      compared to placebo. GB0139 was previously known as TD139.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All subjects eligible for the study will be randomised into one of the two treatment arms:
A. GB0139 3 mg once a day B. Placebo once a day
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: This study is a double-blind study. The blinding will be maintained throughout the study.
measure: Annual rate of decline in Forced Vital Capacity (FVC)
time frame: 52 weeks
description: Efficacy of GB0139 as measured by the annual rate of decline in FVC expressed in mL
measure: Absolute decline in FVC >10%
time frame: 52 weeks
description: Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of > 10%
measure: Time to first hospitalization
time frame: 52 weeks
description: Time to first hospitalization (respiratory related, including acute exacerbation of IPF) expressed in days.
measure: Time to death
time frame: 52 weeks
description: Time to death from all-causes, respiratory-related causes and/or caused by IPF expressed in days
measure: Assessment of Respiratory Related Quality of Life using the St. George's Respiratory Questionnaire (SGRQ)
time frame: 52 weeks
description: Change from baseline in the SGRQ total score. The SGRQ is a 50-item questionnaire split into three domains: symptoms, activity and impact. Weighting of both individual domains and the total score produces a range from 0 to 100, with higher scores indicating a poorer health-related quality of life.
measure: Absolute decline in FVC >5%
time frame: 52 weeks
description: Percentage of subjects with an absolute decline from baseline in FVC (% predicted) of > 5%
measure: 6-minute walk test (6MWT) distance
time frame: 52 weeks
description: Change from baseline in distance walked (metres) over 6 minutes
measure: Diffusion capacity of the lung for carbon monoxide (DLCO)
time frame: 52 weeks
description: Change from baseline in DLCO, corrected for Hemaglobin (mmol/min/kPa)
measure: Assessment of Dyspnea using the University of California San Diego - Shortness of Breath Questionnaire (UCSD - SOBQ)
time frame: Weeks 12, 26 and 52
description: Change from baseline in UCSD - SOBQ Scored from 0-120 where a higher score indicates worse dyspnea
measure: Assessment of Health Related Quality of Life (HRQoL) using the Short-Form 36-Item Health Survey (SF-36)
time frame: Weeks 12, 26 and 52
description: The Medical Outcomes SF-36 It is a self-administered questionnaire of 36-items measuring eight dimensions of general HRQoL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items). In addition to scores for individual dimensions, two summary scores assessing physical and mental dimensions of health and well-being can also be calculated: Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score, respectively. A higher score indicates a more favourable state of health
measure: Frequency of Adverse Events (AE) or Serious Adverse Events (SAE)
time frame: 52 weeks
description: Percentage of subjects with Adverse Events (AE) or Serious Adverse Events (SAE)
measure: Time to hospitalization
time frame: 52 weeks
description: Time in days to first hospitalization from all causes
measure: Time to hospitalization
time frame: 52 weeks
description: Time in days to first hospitalization (IPF related, including acute exacerbation of IPF)
measure: Time to respiratory related death
time frame: 52 weeks
description: Time in days to death from respiratory related causes (including IPF)
measure: Time to initiation of pirfenidone or nintedanib treatment
time frame: 52 weeks
description: Time in days to initiation of pirfenidone or nintedanib treatment in subjects not treated with pirfenidone or nintedanib at time of enrolment
measure: Annual rate of decline in FVC in subjects never treated with pirfenidone or nintedanib
time frame: 52 weeks
description: Change in FVC expressed in mL for subjects who have never been treated with pirfenidone or nintedanib
arm group label: A. GB0139 3 mg once a day
arm group type: Experimental
description: Inhalation of GB0139
arm group label: B. Placebo once a day
arm group type: Placebo Comparator
description: Inhalation of Placebo
intervention type: Drug
intervention name: GB0139
description: GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.
arm group label: A. GB0139 3 mg once a day
other name: TD139
intervention type: Drug
intervention name: Placebo
description: Placebo is administered as inhalation once a day
arm group label: B. Placebo once a day
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Toby Maher, MD, PhD
role: Principal Investigator
affiliation: Keck Medicine of USC
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country: Australia
country: Belgium
country: Canada
country: France
country: Georgia
country: Germany
country: Ireland
country: Israel
country: Italy
country: Poland
country: Spain
country: Ukraine
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Fibrosis