<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/NCT03835481</url>
  </required_header>
  <id_info>
    <org_study_id>1407-0005</org_study_id>
    <secondary_id>2018-003487-31</secondary_id>
    <nct_id>NCT03835481</nct_id>
  </id_info>
  <brief_title>A Study to Test How Well Patients With Plaque Psoriasis Tolerate BI 730357 Over a Longer Period and How Effective it is</brief_title>
  <official_title>Phase II Long-term Extension Study to Assess the Safety, Tolerability, and Efficacy of BI 730357 in Patients With Moderate-to-severe Plaque Psoriasis</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>
      To assess long-term safety, tolerability, and efficacy of BI 730357 in patients with moderate&#xD;
      to severe chronic plaque psoriasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to company decision.&#xD;
  </why_stopped>
  <start_date type="Actual">March 18, 2019</start_date>
  <completion_date type="Actual">July 27, 2021</completion_date>
  <primary_completion_date type="Actual">June 22, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs)</measure>
    <time_frame>For part 1 patients in period 1: Up to 117 days. For part 1 patients in period 2: From week 13 onwards, up to 692 days. For part 2 patients (period 1 + 2): Up to 802 days.</time_frame>
    <description>Number of participants with treatment emergent adverse events (TEAEs). For dose groups 25 mg - 200 mg BI, TEAEs are reported separately for period 1 and period 2.&#xD;
Period 1: All patients who started in period 1 are reported by starting dose (25, 50, 100 and 200 mg).&#xD;
Period 2: Only patients who participated in period 2 are reported by dose sequence group.&#xD;
For dose group 400 mg BI, TEAEs are reported overall (period 1 + period 2). Number of participants with TEAEs is reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24</measure>
    <time_frame>At baseline and at week 24.</time_frame>
    <description>Number of participants with PASI50/75/90/100 response, where PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score.&#xD;
The PASI score is an established measure of clinical efficacy for psoriasis medications, which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72, with a lower score indicating a better outcome. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. The endpoint is based on the percent reduction from baseline, summarized as a dichotomous outcome based on achieving over an X% reduction (or PASI X), where X is 50, 75, 90 and 100.&#xD;
The percent reduction from baseline is calculated by % PASI reduction from baseline = ((PASI at baseline - PASI at Visit X) / PASI at baseline) *100, at all visits with PASI collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24</measure>
    <time_frame>At week 24.</time_frame>
    <description>Number of participants with sPGA clear or almost clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome.&#xD;
0= clear (no signs of psoriasis),&#xD;
almost clear;&#xD;
mild;&#xD;
moderate; 4 = severe (e.g. deep dark red coloration).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24</measure>
    <time_frame>At week 24.</time_frame>
    <description>Number of participants with sPGA clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome.&#xD;
0= clear (No signs of psoriasis),&#xD;
almost clear;&#xD;
mild;&#xD;
moderate; 4 = severe (e.g. deep dark red coloration).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response</measure>
    <time_frame>Up to 802 days.</time_frame>
    <description>The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with PASI50/75/90/100 response at any time and loss of response at the last efficacy assessment is reported.&#xD;
PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score. PASI score is a measure of clinical efficacy for psoriasis medications, which ranges from 0 to 72, with a lower score indicating a better outcome.&#xD;
A patient was a PASI responder if he or she achieved a response at any time from enrollment to 7 days (Residual effect period (REP)) after last dosing date.&#xD;
A patient with the event of loss of response was a responder that lost their PASI response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response</measure>
    <time_frame>Up to 802 days.</time_frame>
    <description>The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear or almost clear response at any time, and loss of response at the last efficacy assessment is reported.&#xD;
The sPGA is based on the physician's assessment of average thickness, erythema and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome).&#xD;
A patient was an sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date. A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response</measure>
    <time_frame>Up to 802 days.</time_frame>
    <description>The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear response at any time, and loss of response at the last efficacy assessment is reported.&#xD;
The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome).&#xD;
A patient was a sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date.&#xD;
A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">165</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>25 mg BI 730357</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>25 mg BI 730357 + placebo under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>50 mg BI 730357</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 mg BI 730357 + placebo under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>100 mg BI 730357</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 mg BI 730357 + placebo under fasted conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>200 mg BI 730357</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200 mg BI 730357 + placebo under fasted conditions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>400 mg BI 730357</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>400 mg BI 730357 + placebo under fasted conditions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 730357</intervention_name>
    <description>Film-coated tablet</description>
    <arm_group_label>100 mg BI 730357</arm_group_label>
    <arm_group_label>200 mg BI 730357</arm_group_label>
    <arm_group_label>25 mg BI 730357</arm_group_label>
    <arm_group_label>400 mg BI 730357</arm_group_label>
    <arm_group_label>50 mg BI 730357</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo to match BI 730357</intervention_name>
    <description>Film-coated tablet</description>
    <arm_group_label>100 mg BI 730357</arm_group_label>
    <arm_group_label>200 mg BI 730357</arm_group_label>
    <arm_group_label>25 mg BI 730357</arm_group_label>
    <arm_group_label>50 mg BI 730357</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman Of Child Bearing Potential (WOCBP) must be ready and able to use highly&#xD;
             effective methods of birth control per International Conference on Harmonisation (ICH)&#xD;
             M3 (R2) that result in a low failure rate of less than 1% per year when used&#xD;
             consistently and correctly from date of screening until 4 weeks after last treatment&#xD;
             in this trial. A list of contraception methods meeting these criteria is provided in&#xD;
             the patient information.&#xD;
&#xD;
          -  Patients with moderate-to-severe plaque Psoriasis (PsO) who have completed treatment&#xD;
             in the preceding trial without early discontinuation, agree to continue treatment in&#xD;
             1407-0005, and&#xD;
&#xD;
               -  for patients entering from Part 1 of trial 1407-0030&#xD;
&#xD;
                  --- achieve a ≥PASI50 response upon completing the trial 1407-0030 Week 24&#xD;
                  end-of-treatment visit&#xD;
&#xD;
               -  for patients entering from Part 2 of trial 1407-0030 --- achieve a ≥PASI50&#xD;
                  response upon completing the trial 1407-0030 Week 12 end-of-treatment visit or&#xD;
                  perceived patient improvement, at the discretion of the Investigator&#xD;
&#xD;
          -  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;
          -  Nonplaque forms of PsO (including guttate, erythrodermic, or pustular), current&#xD;
             druginduced PsO (including a new onset or exacerbation of PsO from, e.g., beta&#xD;
             blockers, calcium channel blockers, lithium), active ongoing inflammatory diseases&#xD;
             (including but not limited to inflammatory bowel disease (IBD)) other than PsO that&#xD;
             might confound trial evaluations.&#xD;
&#xD;
          -  Previous enrolment in this trial.&#xD;
&#xD;
          -  Currently enrolled in another investigational device or drug trial or is receiving&#xD;
             other investigational treatment(s) (with the exception of 1407-0030).&#xD;
&#xD;
          -  Intake of any restricted medication or any drug considered likely to interfere with&#xD;
             the safe conduct of the trial.&#xD;
&#xD;
          -  Any plan to receive a live vaccination during the conduct of the trial.&#xD;
&#xD;
          -  Patients not expected to comply with the protocol requirements or not expected to&#xD;
             complete the trial as scheduled.&#xD;
&#xD;
          -  Chronic alcohol or drug abuse or any condition that, in the investigator's opinion,&#xD;
             makes the patient an unreliable trial participant or unlikely to complete the trial.&#xD;
&#xD;
          -  Women who are pregnant, nursing, or who plan to become pregnant while in the trial.&#xD;
&#xD;
          -  Any documented active or suspected malignancy, except appropriately treated basal cell&#xD;
             carcinoma of the skin, squamous cell carcinoma of the skin, or in situ carcinoma of&#xD;
             uterine cervix.&#xD;
&#xD;
          -  Relevant chronic or acute infections including human immunodeficiency virus (HIV),&#xD;
             viral hepatitis and tuberculosis.&#xD;
&#xD;
          -  Evidence of a disease (including known or suspected IBD, cardiovascular disease), or&#xD;
             medical finding that in the opinion of the Investigator is clinically significant and&#xD;
             would make the study participant unreliable to adhere to the protocol or to complete&#xD;
             the trial, compromise the safety of the patient, or compromise the quality of the&#xD;
             data.&#xD;
&#xD;
          -  Any suicidal ideation, including grade 4 or 5 in the Columbia Suicide Severity Rating&#xD;
             Scale (C-SSRS) in the past 12 months (i.e., active suicidal thought with intent but&#xD;
             without specific plan), or active suicidal thought with plan and intent in the past.&#xD;
&#xD;
          -  Unwillingness to adhere to the rules of UV-light protection&#xD;
&#xD;
          -  Ongoing AEs consistent with intolerance of trial medication (including gastric&#xD;
             intolerance) from 1407-0030, that in the opinion of the investigator would compromise&#xD;
             the safety of the patient.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Total Skin and Beauty Dermatology Center, PC</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatology Research Associates</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Dermatology Inc.</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Research</name>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <zip>30022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Medical Research PC</name>
      <address>
        <city>Sandy Springs</city>
        <state>Georgia</state>
        <zip>30328</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dawes Fretzin Clinical Research Group, LLC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Psoriasis Treatment Center of Central New Jersey</name>
      <address>
        <city>East Windsor</city>
        <state>New Jersey</state>
        <zip>08520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Partners, LLC</name>
      <address>
        <city>Johnston</city>
        <state>Rhode Island</state>
        <zip>02919</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of the Carolinas</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Concepts</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Menter Dermatology Research Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Studies</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Clinical Studies</name>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <zip>77598</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Clinical Research, Inc.</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr Chih-ho Hong Medical Inc</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3R 6A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Enverus Medical Research</name>
      <address>
        <city>Surrey</city>
        <state>British Columbia</state>
        <zip>V3V 0C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Irina Turchin PC Inc.</name>
      <address>
        <city>Fredericton</city>
        <state>New Brunswick</state>
        <zip>E3B 1G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Guenther Dermatology Research Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 3H7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermEdge Research Inc.</name>
      <address>
        <city>Mississauga</city>
        <state>Ontario</state>
        <zip>L5H 1G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Bay Dermatology Centre</name>
      <address>
        <city>North Bay</city>
        <state>Ontario</state>
        <zip>P1B 3Z7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Centre for Clinical Trials</name>
      <address>
        <city>Oakville</city>
        <state>Ontario</state>
        <zip>L6J 7W5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SKiN Centre for Dermatology</name>
      <address>
        <city>Peterborough</city>
        <state>Ontario</state>
        <zip>K9J 5K2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>K. Papp Clinical Research Inc.</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2J 1C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>XLR8 Medical Research Inc.</name>
      <address>
        <city>Windsor</city>
        <state>Ontario</state>
        <zip>N8W 1E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Universitätsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Frankfurt</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60596</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TFS Trial Form Support GmbH</name>
      <address>
        <city>Hamburg</city>
        <zip>20537</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Schleswig-Holstein, Campus Lübeck</name>
      <address>
        <city>Lübeck</city>
        <zip>23538</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_countries>
    <country>Canada</country>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <results_first_submitted>June 20, 2022</results_first_submitted>
  <results_first_submitted_qc>October 27, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 18, 2022</results_first_posted>
  <last_update_submitted>October 27, 2022</last_update_submitted>
  <last_update_submitted_qc>October 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 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>Psoriasis</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>October 6, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03835481/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>March 3, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/81/NCT03835481/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a multicentre, long-term extension trial in patients with moderate-to-severe plaque psoriasis who completed treatment in the preceding trial 1407-0030 (NCT03635099). Patients rolling over from Part 1 of 1407-0030 remained on their blinded BI 730357 dose treatment, until the open label period of 1407-0005 started at Day 1 of week 13 (dose group 25-200 mg). Patients rolling over from Part 2 of 1407-0030 were assigned at visit 1 to receive open label treatment with 400 mg BI 737357.</recruitment_details>
      <pre_assignment_details>All subjects were screened for eligibility prior to participation in the trial. Only subjects which met all inclusion and none of the exclusion criteria were included in the trial. 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>25 mg BI 730357</title>
          <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.</description>
        </group>
        <group group_id="P2">
          <title>50 mg BI 730357</title>
          <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.</description>
        </group>
        <group group_id="P3">
          <title>100 mg BI 730357</title>
          <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.</description>
        </group>
        <group group_id="P4">
          <title>200 mg BI 730357</title>
          <description>Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
        </group>
        <group group_id="P5">
          <title>400 mg BI 730357</title>
          <description>Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double-blind Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="16"/>
                <participants group_id="P4" count="49"/>
                <participants group_id="P5" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="46"/>
                <participants group_id="P5" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="41"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other not stated below</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 group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Termination of treatment by sponsor</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="0"/>
                <participants group_id="P5" count="35"/>
              </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="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</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 group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open Label Period (After Week 12)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">0 patients started period 2, patients were switched to 100 mg.</participants>
                <participants group_id="P2" count="0">0 patients started period 2, patients were switched to 100 mg.</participants>
                <participants group_id="P3" count="35">Combination of Double-blind period dose groups: 25, 50 and 100 mg.</participants>
                <participants group_id="P4" count="46"/>
                <participants group_id="P5" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</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="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="35"/>
                <participants group_id="P4" count="46"/>
                <participants group_id="P5" count="37"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Termination of treatment by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="23"/>
                <participants group_id="P4" count="31"/>
                <participants group_id="P5" count="35"/>
              </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="7"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Covid-19 related, not due to Adverse event</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 group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other not stated above</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 group_id="P5" 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 treatment in the extension trial.</population>
      <group_list>
        <group group_id="B1">
          <title>25 mg BI 730357</title>
          <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.</description>
        </group>
        <group group_id="B2">
          <title>50 mg BI 730357</title>
          <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.</description>
        </group>
        <group group_id="B3">
          <title>100 mg BI 730357</title>
          <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.</description>
        </group>
        <group group_id="B4">
          <title>200 mg BI 730357</title>
          <description>Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
        </group>
        <group group_id="B5">
          <title>400 mg BI 730357</title>
          <description>Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.</description>
        </group>
        <group group_id="B6">
          <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="2"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="16"/>
            <count group_id="B4" value="49"/>
            <count group_id="B5" value="78"/>
            <count group_id="B6" value="165"/>
          </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="41.0" spread="2.8"/>
                    <measurement group_id="B2" value="47.2" spread="18.3"/>
                    <measurement group_id="B3" value="58.1" spread="13.5"/>
                    <measurement group_id="B4" value="49.9" spread="13.3"/>
                    <measurement group_id="B5" value="44.5" spread="13.3"/>
                    <measurement group_id="B6" value="47.7" spread="14.4"/>
                  </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="0"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="22"/>
                    <measurement group_id="B6" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="37"/>
                    <measurement group_id="B5" value="56"/>
                    <measurement group_id="B6" value="116"/>
                  </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="6"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="23"/>
                    <measurement group_id="B6" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="37"/>
                    <measurement group_id="B5" value="55"/>
                    <measurement group_id="B6" value="121"/>
                  </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 group_id="B6" 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 group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="15"/>
                  </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 group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="64"/>
                    <measurement group_id="B6" value="137"/>
                  </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 group_id="B6" 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="1"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs)</title>
        <description>Number of participants with treatment emergent adverse events (TEAEs). For dose groups 25 mg - 200 mg BI, TEAEs are reported separately for period 1 and period 2.&#xD;
Period 1: All patients who started in period 1 are reported by starting dose (25, 50, 100 and 200 mg).&#xD;
Period 2: Only patients who participated in period 2 are reported by dose sequence group.&#xD;
For dose group 400 mg BI, TEAEs are reported overall (period 1 + period 2). Number of participants with TEAEs is reported.</description>
        <time_frame>For part 1 patients in period 1: Up to 117 days. For part 1 patients in period 2: From week 13 onwards, up to 692 days. For part 2 patients (period 1 + 2): Up to 802 days.</time_frame>
        <population>Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. For dose groups 25 mg - 200 mg BI, results are reported separately for period 1 and period 2. For dose group 400 mg BI, results are reported overall (period 1 + period 2).</population>
        <group_list>
          <group group_id="O1">
            <title>25 mg BI 730357</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.</description>
          </group>
          <group group_id="O2">
            <title>50 mg BI 730357</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.</description>
          </group>
          <group group_id="O3">
            <title>100 mg BI 730357</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.</description>
          </group>
          <group group_id="O4">
            <title>200 mg BI 730357</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O5">
            <title>400 mg BI 730357</title>
            <description>Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.</description>
          </group>
          <group group_id="O6">
            <title>25 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O7">
            <title>25 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).</description>
          </group>
          <group group_id="O8">
            <title>50 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O9">
            <title>50 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).</description>
          </group>
          <group group_id="O10">
            <title>100 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O11">
            <title>100 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).</description>
          </group>
          <group group_id="O12">
            <title>200 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to the 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs)</title>
          <description>Number of participants with treatment emergent adverse events (TEAEs). For dose groups 25 mg - 200 mg BI, TEAEs are reported separately for period 1 and period 2.&#xD;
Period 1: All patients who started in period 1 are reported by starting dose (25, 50, 100 and 200 mg).&#xD;
Period 2: Only patients who participated in period 2 are reported by dose sequence group.&#xD;
For dose group 400 mg BI, TEAEs are reported overall (period 1 + period 2). Number of participants with TEAEs is reported.</description>
          <population>Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. For dose groups 25 mg - 200 mg BI, results are reported separately for period 1 and period 2. For dose group 400 mg BI, results are reported overall (period 1 + period 2).</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="2"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="16"/>
                <count group_id="O4" value="49"/>
                <count group_id="O5" value="78"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="1"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="13"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="9"/>
                <count group_id="O12" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="14"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="3"/>
                    <measurement group_id="O9" value="8"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="6"/>
                    <measurement group_id="O12" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24</title>
        <description>Number of participants with PASI50/75/90/100 response, where PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score.&#xD;
The PASI score is an established measure of clinical efficacy for psoriasis medications, which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72, with a lower score indicating a better outcome. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. The endpoint is based on the percent reduction from baseline, summarized as a dichotomous outcome based on achieving over an X% reduction (or PASI X), where X is 50, 75, 90 and 100.&#xD;
The percent reduction from baseline is calculated by % PASI reduction from baseline = ((PASI at baseline - PASI at Visit X) / PASI at baseline) *100, at all visits with PASI collected.</description>
        <time_frame>At baseline and at week 24.</time_frame>
        <population>Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Results are reported by dose sequence group. Only participants with non-missing results are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>25 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O2">
            <title>25 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).</description>
          </group>
          <group group_id="O3">
            <title>50 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O4">
            <title>50 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).</description>
          </group>
          <group group_id="O5">
            <title>100 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O6">
            <title>100 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).</description>
          </group>
          <group group_id="O7">
            <title>200 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O8">
            <title>400 mg BI - 400 mg BI</title>
            <description>Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial. Patients in this group are those part 2 patients who have received treatment for more than 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24</title>
          <description>Number of participants with PASI50/75/90/100 response, where PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score.&#xD;
The PASI score is an established measure of clinical efficacy for psoriasis medications, which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72, with a lower score indicating a better outcome. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. The endpoint is based on the percent reduction from baseline, summarized as a dichotomous outcome based on achieving over an X% reduction (or PASI X), where X is 50, 75, 90 and 100.&#xD;
The percent reduction from baseline is calculated by % PASI reduction from baseline = ((PASI at baseline - PASI at Visit X) / PASI at baseline) *100, at all visits with PASI collected.</description>
          <population>Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Results are reported by dose sequence group. Only participants with non-missing results are reported.</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="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="45"/>
                <count group_id="O8" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PASI50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="8"/>
                    <measurement group_id="O7" value="33"/>
                    <measurement group_id="O8" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PASI75</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="23"/>
                    <measurement group_id="O8" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PASI90</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="10"/>
                    <measurement group_id="O8" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PASI100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24</title>
        <description>Number of participants with sPGA clear or almost clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome.&#xD;
0= clear (no signs of psoriasis),&#xD;
almost clear;&#xD;
mild;&#xD;
moderate; 4 = severe (e.g. deep dark red coloration).</description>
        <time_frame>At week 24.</time_frame>
        <population>Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Results are reported by dose sequence group. Only participants with non-missing results are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>25 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O2">
            <title>25 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).</description>
          </group>
          <group group_id="O3">
            <title>50 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O4">
            <title>50 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).</description>
          </group>
          <group group_id="O5">
            <title>100 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O6">
            <title>100 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily and were up-titrated to 200 mg BI 730357 once daily until end of study (period 2).</description>
          </group>
          <group group_id="O7">
            <title>200 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O8">
            <title>400 mg BI - 400 mg BI</title>
            <description>Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial. Patients in this group are those part 2 patients who have received treatment for more than 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24</title>
          <description>Number of participants with sPGA clear or almost clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome.&#xD;
0= clear (no signs of psoriasis),&#xD;
almost clear;&#xD;
mild;&#xD;
moderate; 4 = severe (e.g. deep dark red coloration).</description>
          <population>Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Results are reported by dose sequence group. Only participants with non-missing results are reported.</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="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="45"/>
                <count group_id="O8" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="18"/>
                    <measurement group_id="O8" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24</title>
        <description>Number of participants with sPGA clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome.&#xD;
0= clear (No signs of psoriasis),&#xD;
almost clear;&#xD;
mild;&#xD;
moderate; 4 = severe (e.g. deep dark red coloration).</description>
        <time_frame>At week 24.</time_frame>
        <population>Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Results are reported by dose sequence group. Only participants with non-missing results are reported.</population>
        <group_list>
          <group group_id="O1">
            <title>25 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O2">
            <title>25 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O3">
            <title>50 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O4">
            <title>50 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O5">
            <title>100 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O6">
            <title>100 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O7">
            <title>200 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O8">
            <title>400 mg BI - 400 mg BI</title>
            <description>Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial. Patients in this group are those part 2 patients who have received treatment for more than 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24</title>
          <description>Number of participants with sPGA clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome.&#xD;
0= clear (No signs of psoriasis),&#xD;
almost clear;&#xD;
mild;&#xD;
moderate; 4 = severe (e.g. deep dark red coloration).</description>
          <population>Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Results are reported by dose sequence group. Only participants with non-missing results are reported.</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="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="13"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="45"/>
                <count group_id="O8" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response</title>
        <description>The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with PASI50/75/90/100 response at any time and loss of response at the last efficacy assessment is reported.&#xD;
PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score. PASI score is a measure of clinical efficacy for psoriasis medications, which ranges from 0 to 72, with a lower score indicating a better outcome.&#xD;
A patient was a PASI responder if he or she achieved a response at any time from enrollment to 7 days (Residual effect period (REP)) after last dosing date.&#xD;
A patient with the event of loss of response was a responder that lost their PASI response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.</description>
        <time_frame>Up to 802 days.</time_frame>
        <population>Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Only participants with non-missing results are reported. Results are reported per starting dose (50, 100, 200 and 400 mg) for patients who participated only in period 1, and per dose-sequence group for patients who participated in period 1 and period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg BI 730357</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.</description>
          </group>
          <group group_id="O2">
            <title>100 mg BI 730357</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.</description>
          </group>
          <group group_id="O3">
            <title>200 mg BI 730357</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O4">
            <title>400 mg BI 730357</title>
            <description>Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.</description>
          </group>
          <group group_id="O5">
            <title>25 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O6">
            <title>25 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O7">
            <title>50 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2)</description>
          </group>
          <group group_id="O8">
            <title>50 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O9">
            <title>100 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O10">
            <title>100 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O11">
            <title>200 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O12">
            <title>400 mg BI - 400 mg BI</title>
            <description>Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial. Patients in this group are those part 2 patients who have received treatment for more than 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response</title>
          <description>The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with PASI50/75/90/100 response at any time and loss of response at the last efficacy assessment is reported.&#xD;
PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score. PASI score is a measure of clinical efficacy for psoriasis medications, which ranges from 0 to 72, with a lower score indicating a better outcome.&#xD;
A patient was a PASI responder if he or she achieved a response at any time from enrollment to 7 days (Residual effect period (REP)) after last dosing date.&#xD;
A patient with the event of loss of response was a responder that lost their PASI response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.</description>
          <population>Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Only participants with non-missing results are reported. Results are reported per starting dose (50, 100, 200 and 400 mg) for patients who participated only in period 1, and per dose-sequence group for patients who participated in period 1 and period 2.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="41"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="13"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="9"/>
                <count group_id="O11" value="46"/>
                <count group_id="O12" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PASI50 Responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="23"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="13"/>
                    <measurement group_id="O9" value="6"/>
                    <measurement group_id="O10" value="9"/>
                    <measurement group_id="O11" value="46"/>
                    <measurement group_id="O12" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PASI50 Loss of Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="5"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="11"/>
                    <measurement group_id="O12" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PASI75 Responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="12"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="6"/>
                    <measurement group_id="O11" value="32"/>
                    <measurement group_id="O12" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PASI75 Loss of Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="2"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="12"/>
                    <measurement group_id="O12" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PASI90 Responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="5"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="3"/>
                    <measurement group_id="O11" value="21"/>
                    <measurement group_id="O12" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PASI90 Loss of Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="12"/>
                    <measurement group_id="O12" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PASI100 Responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="12"/>
                    <measurement group_id="O12" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PASI100 Loss of Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="3"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="7"/>
                    <measurement group_id="O12" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response</title>
        <description>The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear or almost clear response at any time, and loss of response at the last efficacy assessment is reported.&#xD;
The sPGA is based on the physician's assessment of average thickness, erythema and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome).&#xD;
A patient was an sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date. A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.</description>
        <time_frame>Up to 802 days.</time_frame>
        <population>Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Only participants with non-missing results are reported. Results are reported per starting dose (50, 100, 200 and 400 mg) for patients who participated only in period 1, and per dose-sequence group for patients who participated in period 1 and period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg BI 730357</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.</description>
          </group>
          <group group_id="O2">
            <title>100 mg BI 730357</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.</description>
          </group>
          <group group_id="O3">
            <title>200 mg BI 730357</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O4">
            <title>400 mg BI 730357</title>
            <description>Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.</description>
          </group>
          <group group_id="O5">
            <title>25 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O6">
            <title>25 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O7">
            <title>50 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O8">
            <title>50 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O9">
            <title>100 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O10">
            <title>100 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O11">
            <title>200 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O12">
            <title>400 mg BI - 400 mg BI</title>
            <description>Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial. Patients in this group are those part 2 patients who have received treatment for more than 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response</title>
          <description>The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear or almost clear response at any time, and loss of response at the last efficacy assessment is reported.&#xD;
The sPGA is based on the physician's assessment of average thickness, erythema and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome).&#xD;
A patient was an sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date. A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.</description>
          <population>Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Only participants with non-missing results are reported. Results are reported per starting dose (50, 100, 200 and 400 mg) for patients who participated only in period 1, and per dose-sequence group for patients who participated in period 1 and period 2.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="41"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="13"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="9"/>
                <count group_id="O11" value="46"/>
                <count group_id="O12" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Resonders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="13"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="9"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="6"/>
                    <measurement group_id="O11" value="32"/>
                    <measurement group_id="O12" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="3"/>
                    <measurement group_id="O10" value="2"/>
                    <measurement group_id="O11" value="18"/>
                    <measurement group_id="O12" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response</title>
        <description>The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear response at any time, and loss of response at the last efficacy assessment is reported.&#xD;
The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome).&#xD;
A patient was a sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date.&#xD;
A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.</description>
        <time_frame>Up to 802 days.</time_frame>
        <population>Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Only participants with non-missing results are reported. Results are reported per starting dose (50, 100, 200 and 400 mg) for patients who participated only in period 1, and per dose-sequence group for patients who participated in period 1 and period 2.</population>
        <group_list>
          <group group_id="O1">
            <title>50 mg BI 730357</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 milligram (mg) BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open-label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.</description>
          </group>
          <group group_id="O2">
            <title>100 mg BI 730357</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 milligram (mg) BI 730357 and 3 film-coated tablet of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2) or received an optional up-titration to 200 mg BI 730357.</description>
          </group>
          <group group_id="O3">
            <title>200 mg BI 730357</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 2 film-coated tablets of 100 milligram (mg) BI 730357 and 2 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were assigned to 200 mg BI 730357 open label dose, receiving 2 film-coated tablets of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O4">
            <title>400 mg BI 730357</title>
            <description>Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial.</description>
          </group>
          <group group_id="O5">
            <title>25 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O6">
            <title>25 mg BI - 100 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 25 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O7">
            <title>50 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O8">
            <title>50 mg BI - 100 mg BI - 200 mg</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 50 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O9">
            <title>100 mg BI - 100 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O10">
            <title>100 mg BI - 100 mg - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O11">
            <title>200 mg BI - 200 mg BI</title>
            <description>Patients entering from part 1 of 1407-0030 were administered 1 film-coated tablet of 100 mg BI 730357 and 3 film-coated tablets of placebo orally once daily (q.d.) under fasted conditions for the initial 12 week double-blind treatment period (period 1). At day 1 of week 13 (visit 2) patients were reassigned to the 100 mg BI 730357 open label dose, receiving 1 film-coated tablet of 100 mg BI 730357 orally administered once daily until end of study (period 2).</description>
          </group>
          <group group_id="O12">
            <title>400 mg BI - 400 mg BI</title>
            <description>Patients entering from part 2 of 1407-0030 were administered open label treatment of 4 film-coated tablets of 100 milligram (mg) BI730357 orally once daily (QD) under fed conditions throughout the trial. Patients in this group are those part 2 patients who have received treatment for more than 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response</title>
          <description>The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear response at any time, and loss of response at the last efficacy assessment is reported.&#xD;
The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome).&#xD;
A patient was a sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date.&#xD;
A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.</description>
          <population>Treated Set (TS): All patients who received at least one dose of treatment in the extension trial. Only participants with non-missing results are reported. Results are reported per starting dose (50, 100, 200 and 400 mg) for patients who participated only in period 1, and per dose-sequence group for patients who participated in period 1 and period 2.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="41"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="5"/>
                <count group_id="O8" value="13"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="9"/>
                <count group_id="O11" value="46"/>
                <count group_id="O12" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Resonders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="1"/>
                    <measurement group_id="O11" value="12"/>
                    <measurement group_id="O12" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="3"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="7"/>
                    <measurement group_id="O12" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of treatment until last dose, plus 7 days of residual effect period, up to 802 days.</time_frame>
      <desc>Treated Set (TS): All participants who received at least one dose of treatment in the extension trial. Arms are not mutually exclusive.</desc>
      <group_list>
        <group group_id="E1">
          <title>25 mg BI 730357 (Actual Dose)</title>
          <description>Patients received 25 mg of BI 730357 orally once daily under fasted conditions in period 1. This group includes all subjects who actually received 25 mg BI 730357.</description>
        </group>
        <group group_id="E2">
          <title>50 mg BI 730357 (Actual Dose)</title>
          <description>Patients received 50 mg of BI 730357 orally once daily under fasted conditions in period 1. This group includes all subjects who actually received 50 mg BI 730357.</description>
        </group>
        <group group_id="E3">
          <title>100 mg BI 730357 BI (Actual Dose)</title>
          <description>Patients who received 100 mg of BI 730357 orally once daily under fasted conditions in period 1 and/or period 2. This group includes all subjects who actually received 100 mg BI 730357.</description>
        </group>
        <group group_id="E4">
          <title>200 mg BI 730357 (Actual Dose)</title>
          <description>Patients received 200 mg of BI 730357 orally once daily under fasted conditions in period 1 and/or period 2. This group includes all subjects who actually received 200 mg BI 730357.</description>
        </group>
        <group group_id="E5">
          <title>400 mg BI 730357 (Actual Dose)</title>
          <description>Patients received 400 mg of BI 730357 orally once daily under fed conditions throughout the trial. This group includes all subjects who actually received 400 mg BI 730357.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.0</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="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.0</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="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="78"/>
              </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="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="78"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="72"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="78"/>
              </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>
    <limitations_and_caveats>The trial was ended prematurely by the sponsor. As a consequence, primary and secondary endpoints were limited to descriptive outcome measures. The recruitment was completed as planned.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim, Call Centre</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/NCT03835481
org study id: 1407-0005
secondary id: 2018-003487-31
nct id: NCT03835481
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
To assess long-term safety, tolerability, and efficacy of BI 730357 in patients with moderate
      to severe chronic plaque psoriasis.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
time frame: For part 1 patients in period 1: Up to 117 days. For part 1 patients in period 2: From week 13 onwards, up to 692 days. For part 2 patients (period 1 + 2): Up to 802 days.
description: Number of participants with treatment emergent adverse events (TEAEs). For dose groups 25 mg - 200 mg BI, TEAEs are reported separately for period 1 and period 2.
Period 1: All patients who started in period 1 are reported by starting dose (25, 50, 100 and 200 mg).
Period 2: Only patients who participated in period 2 are reported by dose sequence group.
For dose group 400 mg BI, TEAEs are reported overall (period 1 + period 2). Number of participants with TEAEs is reported.
measure: Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90/PASI100 Response at Week 24
time frame: At baseline and at week 24.
description: Number of participants with PASI50/75/90/100 response, where PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score.
The PASI score is an established measure of clinical efficacy for psoriasis medications, which provides a numeric scoring for patients overall psoriasis disease state, ranging from 0 to 72, with a lower score indicating a better outcome. It is a linear combination of percent of surface area of skin that is affected and the severity of erythema, infiltration, and desquamation over four body regions. The endpoint is based on the percent reduction from baseline, summarized as a dichotomous outcome based on achieving over an X% reduction (or PASI X), where X is 50, 75, 90 and 100.
The percent reduction from baseline is calculated by % PASI reduction from baseline = ((PASI at baseline - PASI at Visit X) / PASI at baseline) *100, at all visits with PASI collected.
measure: Number of Participants With Static Physician Global Assessment (sPGA) Clear or Almost Clear Response at Week 24
time frame: At week 24.
description: Number of participants with sPGA clear or almost clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome.
0= clear (no signs of psoriasis),
almost clear;
mild;
moderate; 4 = severe (e.g. deep dark red coloration).
measure: Number of Participants With Static Physician Global Assessment (sPGA) Clear Response at Week 24
time frame: At week 24.
description: Number of participants with sPGA clear response at week 24. The sPGA is a 5 point score based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The score ranges from 0 - 4, with a lower score indicating a better outcome.
0= clear (No signs of psoriasis),
almost clear;
mild;
moderate; 4 = severe (e.g. deep dark red coloration).
measure: Number of Participants With Psoriasis Area and Severity Index (PASI)50/PASI75/PASI90 or PASI100 Response at Any Time and Loss of PASI Response
time frame: Up to 802 days.
description: The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with PASI50/75/90/100 response at any time and loss of response at the last efficacy assessment is reported.
PASI50/75/90/100 is 50%/75%/90%/100% reduction in PASI score. PASI score is a measure of clinical efficacy for psoriasis medications, which ranges from 0 to 72, with a lower score indicating a better outcome.
A patient was a PASI responder if he or she achieved a response at any time from enrollment to 7 days (Residual effect period (REP)) after last dosing date.
A patient with the event of loss of response was a responder that lost their PASI response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.
measure: Number of Participants With Static Physician's Global Assessment (sPGA) Clear or Almost Clear Response at Any Time and Loss of sPGA Clear or Almost Clear Response
time frame: Up to 802 days.
description: The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear or almost clear response at any time, and loss of response at the last efficacy assessment is reported.
The sPGA is based on the physician's assessment of average thickness, erythema and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome).
A patient was an sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date. A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.
measure: Number of Participants With Static Physician's Global Assessment (sPGA) Clear Response at Any Time and Loss of sPGA Clear Response
time frame: Up to 802 days.
description: The time-to-loss analysis of PASI response was not performed because the analysis would not provide any statistically valid estimates of the parameter due to the premature ending of the trial. Instead, the number of participants with sPGA clear response at any time, and loss of response at the last efficacy assessment is reported.
The sPGA is based on the physician's assessment of the average thickness, erythema, and scaling of all psoriatic lesions. It ranges from 0 to 4, with 0=clear (best outcome), 1=almost clear, 2=mild, 3=moderate and 4=severe (worst outcome).
A patient was a sPGA responder if he or she achieved a response at any time from enrolment to 7 days (residual effect period (REP)) after last dosing date.
A patient with the event of loss of response was a responder that lost their sPGA response at the last efficacy assessment regardless if it was done within 7 days (REP) after the last dosing date or not.
arm group label: 25 mg BI 730357
arm group type: Experimental
description: 25 mg BI 730357 + placebo under fasted conditions.
arm group label: 50 mg BI 730357
arm group type: Experimental
description: 50 mg BI 730357 + placebo under fasted conditions.
arm group label: 100 mg BI 730357
arm group type: Experimental
description: 100 mg BI 730357 + placebo under fasted conditions.
arm group label: 200 mg BI 730357
arm group type: Experimental
description: 200 mg BI 730357 + placebo under fasted conditions
arm group label: 400 mg BI 730357
arm group type: Experimental
description: 400 mg BI 730357 + placebo under fasted conditions.
intervention type: Drug
intervention name: BI 730357
description: Film-coated tablet
arm group label: 100 mg BI 730357
arm group label: 200 mg BI 730357
arm group label: 25 mg BI 730357
arm group label: 400 mg BI 730357
arm group label: 50 mg BI 730357
intervention type: Drug
intervention name: Placebo to match BI 730357
description: Film-coated tablet
arm group label: 100 mg BI 730357
arm group label: 200 mg BI 730357
arm group label: 25 mg BI 730357
arm group label: 50 mg BI 730357
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
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country: Canada
country: Germany
country: United States
url: http://www.mystudywindow.com
description: Related Info
responsible party type: Sponsor
mesh term: Psoriasis
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: 
limitations and caveats: The trial was ended prematurely by the sponsor. As a consequence, primary and secondary endpoints were limited to descriptive outcome measures. The recruitment was completed as planned.
point of contact: 