<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/NCT04419506</url>
  </required_header>
  <id_info>
    <org_study_id>1305-0013</org_study_id>
    <secondary_id>2019-004167-45</secondary_id>
    <nct_id>NCT04419506</nct_id>
  </id_info>
  <brief_title>A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)</brief_title>
  <official_title>A Randomised, Double-blind, Placebo-controlled Parallel Group Study in IPF Patients Over 12 Weeks Evaluating Efficacy, Safety and Tolerability of BI 1015550 Taken Orally</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</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 study is open to adults with idiopathic pulmonary fibrosis (IPF) who are at least 40&#xD;
      years old. People taking standard medicines for IPF, including antifibrotic medicines, can&#xD;
      continue taking them throughout the study.&#xD;
&#xD;
      The purpose of the study is to find out whether a medicine called BI 1015550 can slow down&#xD;
      the worsening of lung function. Participants are in the study for about 4 months. During this&#xD;
      time, they visit the study site about 7 times. At the beginning, they visit the study site&#xD;
      every 2 weeks.&#xD;
&#xD;
      After 1 month of treatment, they visit the study site every 4 weeks.&#xD;
&#xD;
      The participants are put into 2 groups by chance. 1 group gets BI 1015550. The other group&#xD;
      gets placebo. Placebo tablets look like BI 1015550 tablets but contain no medicine. The&#xD;
      participants take BI 1015550 or placebo tablets twice a day.&#xD;
&#xD;
      The participants have lung function tests at study visits. The results of the lung function&#xD;
      tests are compared between the BI 1015550 group and the placebo group. The doctors also&#xD;
      regularly check the general health of the participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 28, 2020</start_date>
  <completion_date type="Actual">October 15, 2021</completion_date>
  <primary_completion_date type="Actual">October 6, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Change From Baseline in Forced Vital Capacity (FVC) at 12 Weeks</measure>
    <time_frame>Baseline (day 1) and week 12.</time_frame>
    <description>The change from baseline in Forced vital capacity (FVC) at 12 weeks. Data were analysed with a restricted maximum likelihood (REML)-based approach using a mixed model with repeated measures (MMRM). The analysis included the fixed, categorical effect of treatment at each visit, and the fixed, continuous effects of baseline FVC at each visit. Visit was treated as the repeated measure, with an unstructured covariance structure used to model the within-patient measurements.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Number of Patients With Treatment Emergent Adverse Event</measure>
    <time_frame>From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.</time_frame>
    <description>The number of patients with any adverse event during the on-treatment period.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">147</enrollment>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <arm_group>
    <arm_group_label>Placebo, Antifibrotics at baseline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Idiopathic pulmonary fibrosis (IPF) patients on stable antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their stable background therapy of nintedanib or prifenidone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 1015550, Antifibrotics at baseline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Idiopathic pulmonary fibrosis (IPF) patients on stable antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their stable background therapy of nintedanib or prifenidone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo, Non-antifibrotics at baseline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Idiopathic pulmonary fibrosis (IPF) patients not on stable antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 1015550, Non-antifibrotics at baseline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Idiopathic pulmonary fibrosis (IPF) patients not on stable antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 1015550</intervention_name>
    <description>18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks.</description>
    <arm_group_label>BI 1015550, Antifibrotics at baseline</arm_group_label>
    <arm_group_label>BI 1015550, Non-antifibrotics at baseline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks.</description>
    <arm_group_label>Placebo, Antifibrotics at baseline</arm_group_label>
    <arm_group_label>Placebo, Non-antifibrotics at baseline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged ≥40 years when signing the informed consent.&#xD;
&#xD;
          2. Diagnosis:&#xD;
&#xD;
               1. IPF based on 2018 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator&#xD;
                  based on chest High Resolution Computed Tomography Scan (HRCT) scan taken within&#xD;
                  12 months of Visit 1 and if available surgical lung biopsy.&#xD;
&#xD;
                  and&#xD;
&#xD;
               2. Usual interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with&#xD;
                  the clinical diagnosis of IPF, as confirmed by central review prior to Visit 2*&#xD;
&#xD;
                    -  if indeterminate HRCT finding IPF may be confirmed locally by (historical)&#xD;
                       biopsy&#xD;
&#xD;
          3. Stable for at least 8 weeks prior to Visit 1. Patients have to be either :&#xD;
&#xD;
               -  not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit&#xD;
                  1 (combination of nintedanib plus pirfenidone not allowed), or&#xD;
&#xD;
               -  on stable* therapy with nintedanib or pirfenidone for at least 8 weeks prior to&#xD;
                  Visit 1 and planning to stay stable on this background therapy after&#xD;
                  randomisation.&#xD;
&#xD;
             [*stable therapy is defined as the individually and general tolerated regimen of&#xD;
             either pirfenidone or nintedanib]&#xD;
&#xD;
          4. Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1&#xD;
&#xD;
          5. Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin&#xD;
             [Hb] [Visit 1]) ≥ 25% to &lt; 80% of predicted normal at Visit 1.&#xD;
&#xD;
          6. Signed and dated written informed consent in accordance with ICH-GCP and local&#xD;
             legislation prior to admission to the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one&#xD;
             second (FEV1)/Forced Vital Capacity (FVC) &lt; 0.7) at Visit 1.&#xD;
&#xD;
          2. In the opinion of the Investigator, other clinically significant pulmonary&#xD;
             abnormalities.&#xD;
&#xD;
          3. Acute IPF exacerbation within 4 months prior to screening and/or during the screening&#xD;
             period (investigator-determined).&#xD;
&#xD;
          4. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Visit&#xD;
             1 and/or during the screening period.&#xD;
&#xD;
          5. Major surgery (major according to the investigator's assessment) performed within 3&#xD;
             months prior to Visit 1 or planned during the course of the trial. (Being on a&#xD;
             transplant list is allowed).&#xD;
&#xD;
          6. Any documented active or suspected malignancy or history of malignancy within 5 years&#xD;
             prior to Visit 1, except appropriately treated basal cell carcinoma of the skin,&#xD;
             &quot;under surveillance&quot; prostate cancer or in situ carcinoma of uterine cervix.&#xD;
&#xD;
          7. Evidence of active infection (chronic or acute) based on clinical exam or laboratory&#xD;
             findings at Visit 1 or at Visit 2.&#xD;
&#xD;
          8. Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted attempt,&#xD;
             aborted attempt, or preparatory acts or behavior).&#xD;
&#xD;
          9. The patient has a confirmed infection with SARS-CoV-2 within the 4 weeks prior to&#xD;
             Visit 1 and/or during the screening period.&#xD;
&#xD;
        Further exclusion criteria apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St. Francis Medical Institute</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33765</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</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>Mayo Clinic, Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</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>Creighton University</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Research Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</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>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</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 Sciences Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigaciones Metabólicas (CINME)</name>
      <address>
        <city>C.a.b.a</city>
        <zip>C1027AAP</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH-Univ. Hospital Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Georges-L.-Dumont University Hospital Centre</name>
      <address>
        <city>Moncton</city>
        <state>New Brunswick</state>
        <zip>E1C 2Z3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's University</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Syed 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>Centre Hospitalier de l'Universite de Montreal (CHUM)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional del Tórax</name>
      <address>
        <city>Providencia, Santiago De Chile</city>
        <zip>7500691</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigación del Maule</name>
      <address>
        <city>Talca</city>
        <zip>3465586</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <zip>130041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital</name>
      <address>
        <city>Chengdu</city>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Pulmonary Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Thomayer's Hospital</name>
      <address>
        <city>Praha 4 - Krc</city>
        <zip>140 59</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Na Bulovce, Prague</name>
      <address>
        <city>Praha</city>
        <zip>180 81</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herlev and Gentofte Hospital</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HYKS Keuhkosairauksien tutkimusyksikkö</name>
      <address>
        <city>Helsinki</city>
        <zip>00290</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>KYS, Keuhkosairauksien</name>
      <address>
        <city>Kuopio</city>
        <zip>70210</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oulun yliopistollinen keskussairaala</name>
      <address>
        <city>Oulu</city>
        <zip>FIN-90220</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampere University Hospital</name>
      <address>
        <city>Tampere</city>
        <zip>33521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TYKS</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fachkrankenhaus Coswig GmbH</name>
      <address>
        <city>Coswig</city>
        <zip>01640</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH</name>
      <address>
        <city>Essen</city>
        <zip>45239</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lungenfachklinik Immenhausen</name>
      <address>
        <city>Immenhausen</city>
        <zip>34376</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Athens Medical Center</name>
      <address>
        <city>Athens</city>
        <zip>15125</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Heraklion</name>
      <address>
        <city>Crete</city>
        <zip>71110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ. Gen. Hosp. of Patras</name>
      <address>
        <city>Patras</city>
        <zip>26504</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis University</name>
      <address>
        <city>Budapest</city>
        <zip>1085</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Colonnello D Avanzo</name>
      <address>
        <city>Foggia</city>
        <zip>71100</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>Poli Univ A. Gemelli</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Senese Policlinico Santa Maria alle Scotte</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tosei General Hospital</name>
      <address>
        <city>Aichi, Seto</city>
        <zip>489-8642</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Medical Center</name>
      <address>
        <city>Fukuoka, Fukuoka</city>
        <zip>810-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cardiovascular and Respiratory Center</name>
      <address>
        <city>Kanagawa, Yokohama</city>
        <zip>236-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kinki-Chuo Chest Medical Center</name>
      <address>
        <city>Osaka, Sakai</city>
        <zip>591-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamamatsu University Hospital</name>
      <address>
        <city>Shizuoka, Hamamatsu</city>
        <zip>431-3192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center Hospital of the National Center for Global Health and Medicine</name>
      <address>
        <city>Tokyo, Shinjuku-ku</city>
        <zip>162-8655</zip>
        <country>Japan</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>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zuyderland Medisch Centrum</name>
      <address>
        <city>Heerlen</city>
        <zip>6419 PC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius ziekenhuis, locatie Nieuwegein</name>
      <address>
        <city>Nieuwegein</city>
        <zip>3435 CM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus Medisch Centrum</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Center, Gdansk</name>
      <address>
        <city>Gdansk</city>
        <zip>80-214</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal state budgetary scientific institution &quot;Research Institute of occupational medicine named after academician N. F. Izmerov</name>
      <address>
        <city>Moscow</city>
        <zip>105275</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow 1st State Med.Univ.n.a.I.M.Sechenov</name>
      <address>
        <city>Moscow</city>
        <zip>119992</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlínica Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Bellvitge</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Central de Asturias</name>
      <address>
        <city>Oviedo</city>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Son Espases</name>
      <address>
        <city>Palma de Mallorca</city>
        <zip>07120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dnyepropyetrovsk Medical Academy, Clinical Hospital No. 6</name>
      <address>
        <city>Dnyepropyetrovsk</city>
        <zip>49074</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instit.Phthisiology&amp;Pulmon.na Yanovskiy,Non-Specif.Lung,Kyiv</name>
      <address>
        <city>Kyiv</city>
        <zip>03680</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southmead Hospital</name>
      <address>
        <city>Bristol</city>
        <zip>BS10 5NB</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_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>China</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <results_first_submitted>October 5, 2022</results_first_submitted>
  <results_first_submitted_qc>October 5, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 1, 2022</results_first_posted>
  <last_update_submitted>October 5, 2022</last_update_submitted>
  <last_update_submitted_qc>October 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Fibrosis</mesh_term>
    <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed &quot;Document Sharing Agreement&quot;.&#xD;
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.&#xD;
The data shared are the raw clinical study data sets.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.</ipd_time_frame>
    <ipd_access_criteria>For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.</ipd_access_criteria>
    <ipd_url>https://www.mystudywindow.com/msw/datasharing</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT04419506/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 8, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT04419506/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a trial with a randomised, placebo-controlled, double-blind, parallel-group design over 12 weeks, including a screening period of up to 44 days, a 12-week treatment period, and a 1-week follow-up period in patients with idiopathic pulmonary fibrosis (IPF) stratified by baseline antifibrotic treatment (Non-AF stratum: patients not on antifibrotic treatment at baseline; AF stratum: stable antifibrotic treatment with nintedanib or pirfenidone at baseline).</recruitment_details>
      <pre_assignment_details>All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo - Antifibrotics at Baseline</title>
          <description>Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.</description>
        </group>
        <group group_id="P2">
          <title>BI 1015550 - Antifibrotics at Baseline</title>
          <description>Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.</description>
        </group>
        <group group_id="P3">
          <title>Placebo - Non-antifibrotics at Baseline</title>
          <description>Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment.</description>
        </group>
        <group group_id="P4">
          <title>BI 1015550 - Non-antifibrotics at Baseline</title>
          <description>Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="49"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="43"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>poor-compliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated Set (TS): all patients who received at least one dose of trial drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo - Antifibrotics at Baseline</title>
          <description>Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.</description>
        </group>
        <group group_id="B2">
          <title>BI 1015550 - Antifibrotics at Baseline</title>
          <description>Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.</description>
        </group>
        <group group_id="B3">
          <title>Placebo - Non-antifibrotics at Baseline</title>
          <description>Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment.</description>
        </group>
        <group group_id="B4">
          <title>BI 1015550 - Non-antifibrotics at Baseline</title>
          <description>Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="25"/>
            <count group_id="B2" value="49"/>
            <count group_id="B3" value="25"/>
            <count group_id="B4" value="48"/>
            <count group_id="B5" value="147"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.5" spread="10.7"/>
                    <measurement group_id="B2" value="69.3" spread="6.6"/>
                    <measurement group_id="B3" value="71.8" spread="9.3"/>
                    <measurement group_id="B4" value="69.9" spread="8.3"/>
                    <measurement group_id="B5" value="69.6" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="34"/>
                    <measurement group_id="B5" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="43"/>
                    <measurement group_id="B5" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="115"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Forced vital capacity (FVC)</title>
          <description>Forced vital capacity (FVC) at baseline. FVC is the total amount of air exhaled during a Forced expiratory volume (FEV) test.</description>
          <population>Treated Set (TS): all patients who received at least one dose of trial drug.</population>
          <units>Milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2690.000" spread="889.985"/>
                    <measurement group_id="B2" value="2875.551" spread="752.818"/>
                    <measurement group_id="B3" value="2864.920" spread="1015.104"/>
                    <measurement group_id="B4" value="2782.938" spread="835.104"/>
                    <measurement group_id="B5" value="2811.946" spread="845.625"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Change From Baseline in Forced Vital Capacity (FVC) at 12 Weeks</title>
        <description>The change from baseline in Forced vital capacity (FVC) at 12 weeks. Data were analysed with a restricted maximum likelihood (REML)-based approach using a mixed model with repeated measures (MMRM). The analysis included the fixed, categorical effect of treatment at each visit, and the fixed, continuous effects of baseline FVC at each visit. Visit was treated as the repeated measure, with an unstructured covariance structure used to model the within-patient measurements.</description>
        <time_frame>Baseline (day 1) and week 12.</time_frame>
        <population>Full Analysis Set (FAS): all patients who received at least one dose of trial drug and who had a baseline and at least one post-baseline measurement available for Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1) or Diffusion Capacity of the Lung for Carbon Monoxide (DLCO).</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Antifibrotics at Baseline</title>
            <description>Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.</description>
          </group>
          <group group_id="O2">
            <title>BI 1015550 - Antifibrotics at Baseline</title>
            <description>Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Non-antifibrotics at Baseline</title>
            <description>Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment.</description>
          </group>
          <group group_id="O4">
            <title>BI 1015550 - Non-antifibrotics at Baseline</title>
            <description>Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline in Forced Vital Capacity (FVC) at 12 Weeks</title>
          <description>The change from baseline in Forced vital capacity (FVC) at 12 weeks. Data were analysed with a restricted maximum likelihood (REML)-based approach using a mixed model with repeated measures (MMRM). The analysis included the fixed, categorical effect of treatment at each visit, and the fixed, continuous effects of baseline FVC at each visit. Visit was treated as the repeated measure, with an unstructured covariance structure used to model the within-patient measurements.</description>
          <population>Full Analysis Set (FAS): all patients who received at least one dose of trial drug and who had a baseline and at least one post-baseline measurement available for Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1) or Diffusion Capacity of the Lung for Carbon Monoxide (DLCO).</population>
          <units>Milliliter</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="48"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-77.70" lower_limit="-124.87" upper_limit="-30.53"/>
                    <measurement group_id="O2" value="2.72" lower_limit="-33.46" upper_limit="38.89"/>
                    <measurement group_id="O3" value="-95.62" lower_limit="-157.13" upper_limit="-34.10"/>
                    <measurement group_id="O4" value="6.10" lower_limit="-39.67" upper_limit="51.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Adjusted means in the placebo group were combined with the meta-analytic predictive priors derived based on the clinical trials in the nintedanib clinical development program in IPF. In order to evaluate the treatment effects, the posterior distribution for the treatment difference of BI 1015550 versus placebo with respect to the primary endpoint was used. The median of the posterior distribution for the treatment difference (and 95% credible intervals) was calculated.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Posterior difference</param_type>
            <param_value>88.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>29.5</ci_lower_limit>
            <ci_upper_limit>154.2</ci_upper_limit>
            <estimate_desc>Difference calculated as BI 1015550 - Placebo</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Adjusted means in the placebo group were combined with the meta-analytic predictive priors derived based on the clinical trials in the nintedanib clinical development program in IPF. In order to evaluate the treatment effects, the posterior distribution for the treatment difference of BI 1015550 versus placebo with respect to the primary endpoint was used. The median of the posterior distribution for the treatment difference (and 95% credible intervals) was calculated.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Posterior difference</param_type>
            <param_value>62.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.3</ci_lower_limit>
            <ci_upper_limit>125.5</ci_upper_limit>
            <estimate_desc>Difference calculated as BI 1015550 - Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Patients With Treatment Emergent Adverse Event</title>
        <description>The number of patients with any adverse event during the on-treatment period.</description>
        <time_frame>From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.</time_frame>
        <population>Treated Set (TS): all patients who received at least one dose of trial drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo - Antifibrotics at Baseline</title>
            <description>Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.</description>
          </group>
          <group group_id="O2">
            <title>BI 1015550 - Antifibrotics at Baseline</title>
            <description>Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.</description>
          </group>
          <group group_id="O3">
            <title>Placebo - Non-antifibrotics at Baseline</title>
            <description>Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment.</description>
          </group>
          <group group_id="O4">
            <title>BI 1015550 - Non-antifibrotics at Baseline</title>
            <description>Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Patients With Treatment Emergent Adverse Event</title>
          <description>The number of patients with any adverse event during the on-treatment period.</description>
          <population>Treated Set (TS): all patients who received at least one dose of trial drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.</time_frame>
      <desc>Treated Set (TS): all patients who received at least one dose of trial drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo - Antifibrotics at Baseline</title>
          <description>Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.</description>
        </group>
        <group group_id="E2">
          <title>BI 1015550 - Antifibrotics at Baseline</title>
          <description>Idiopathic pulmonary fibrosis (IPF) patients on antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their background therapy of nintedanib or prifenidone.</description>
        </group>
        <group group_id="E3">
          <title>Placebo - Non-antifibrotics at Baseline</title>
          <description>Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of placebo treatment.</description>
        </group>
        <group group_id="E4">
          <title>BI 1015550 - Non-antifibrotics at Baseline</title>
          <description>Idiopathic pulmonary fibrosis (IPF) patients not on antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. Patients were not expected to start antifibrotic treatment during the 12 weeks of BI 1015550 treatment.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Condition aggravated</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral nerve paresis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis exfoliative</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="48"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="25"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="25"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="48"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim, Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04419506
org study id: 1305-0013
secondary id: 2019-004167-45
nct id: NCT04419506
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are at least 40
      years old. People taking standard medicines for IPF, including antifibrotic medicines, can
      continue taking them throughout the study.

      The purpose of the study is to find out whether a medicine called BI 1015550 can slow down
      the worsening of lung function. Participants are in the study for about 4 months. During this
      time, they visit the study site about 7 times. At the beginning, they visit the study site
      every 2 weeks.

      After 1 month of treatment, they visit the study site every 4 weeks.

      The participants are put into 2 groups by chance. 1 group gets BI 1015550. The other group
      gets placebo. Placebo tablets look like BI 1015550 tablets but contain no medicine. The
      participants take BI 1015550 or placebo tablets twice a day.

      The participants have lung function tests at study visits. The results of the lung function
      tests are compared between the BI 1015550 group and the placebo group. The doctors also
      regularly check the general health of the participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The Change From Baseline in Forced Vital Capacity (FVC) at 12 Weeks
time frame: Baseline (day 1) and week 12.
description: The change from baseline in Forced vital capacity (FVC) at 12 weeks. Data were analysed with a restricted maximum likelihood (REML)-based approach using a mixed model with repeated measures (MMRM). The analysis included the fixed, categorical effect of treatment at each visit, and the fixed, continuous effects of baseline FVC at each visit. Visit was treated as the repeated measure, with an unstructured covariance structure used to model the within-patient measurements.
measure: The Number of Patients With Treatment Emergent Adverse Event
time frame: From the start of treatment till the end of treatment + 7 days residual effect period, an average of 87.4 days.
description: The number of patients with any adverse event during the on-treatment period.
arm group label: Placebo, Antifibrotics at baseline
arm group type: Placebo Comparator
description: Idiopathic pulmonary fibrosis (IPF) patients on stable antifibrotic treatment with nintedanib or pirfenidone at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their stable background therapy of nintedanib or prifenidone.
arm group label: BI 1015550, Antifibrotics at baseline
arm group type: Experimental
description: Idiopathic pulmonary fibrosis (IPF) patients on stable antifibrotic treatment with nintedanib or pirfenidone at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks. During the 12-weeks of administration of BI 1015550 patients stayed on their stable background therapy of nintedanib or prifenidone.
arm group label: Placebo, Non-antifibrotics at baseline
arm group type: Placebo Comparator
description: Idiopathic pulmonary fibrosis (IPF) patients not on stable antifibrotic treatment at baseline were administered placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks.
arm group label: BI 1015550, Non-antifibrotics at baseline
arm group type: Experimental
description: Idiopathic pulmonary fibrosis (IPF) patients not on stable antifibrotic treatment at baseline were administered 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks.
intervention type: Drug
intervention name: BI 1015550
description: 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks.
arm group label: BI 1015550, Antifibrotics at baseline
arm group label: BI 1015550, Non-antifibrotics at baseline
intervention type: Drug
intervention name: Placebo
description: placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks.
arm group label: Placebo, Antifibrotics at baseline
arm group label: Placebo, Non-antifibrotics at baseline
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
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country: Argentina
country: Australia
country: Austria
country: Canada
country: Chile
country: China
country: Czechia
country: Denmark
country: Finland
country: Germany
country: Greece
country: Hungary
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: Poland
country: Russian Federation
country: Spain
country: Ukraine
country: United Kingdom
country: United States
url: http://mystudywindow.com
description: Related Info
responsible party type: Sponsor
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Fibrosis
sharing ipd: Yes
ipd description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
ipd access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
ipd url: https://www.mystudywindow.com/msw/datasharing
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 